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1.  Efficacy and safety of the C-Qur™ Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial 
Trials  2014;15(1):378.
Adhesions develop in over 90% of patients after intra-abdominal surgery. Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions. Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery. This agent has limitations through poor handling characteristics because it is sticky on both sides. C-Qur™ Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics. The objective of this study is to assess efficacy and safety of C-Qur™ Film to decrease the incidence of adhesions after colorectal surgery.
This is a prospective, investigator initiated, randomized, double-blinded, multicenter trial. Eligible patients undergoing colorectal resection requiring temporary loop ileostomy or loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the trial. Before closure, patients are randomized 1:1 to either the treatment arm (C-Qur™ Film) or control arm (no adhesion barrier). Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy. During ostomy takedown, adhesions will be evaluated for incidence, extent, and severity. The primary outcome evaluation will be assessment of adhesions to the incision site. It is hypothesized that the use of C-Qur™ Film underneath the primary incision reduces the incidence of adhesion at the incision by 30%. To demonstrate 30% reduction in the incidence of adhesions, a sample size of 84 patients (32 + 10 per group (25% drop out)) is required (two-sided test, α = 0.05, 80% power).
Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic ‘hand-assisted’ colorectal surgery. We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction, secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret. Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention, since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished.
Trial registration Identifier NCT01872650, registration date 6 June 2013.
PMCID: PMC4195905  PMID: 25260232
adhesions; adhesion prevention; anti-adhesive barrier; C-Qur™ film; colorectal surgery
2.  Complication Rates of Ostomy Surgery Are High and Vary Significantly Between Hospitals 
Diseases of the colon and rectum  2014;57(5):632-637.
Structured Abstract
Ostomy surgery is common and has traditionally been associated with high rates of morbidity and mortality, suggesting an important target for quality improvement.
To evaluate the variation in outcomes after ostomy creation surgery within Michigan in order to identify targets for quality improvement.
Retrospective cohort study.
The 34-hospital Michigan Surgical Quality Collaborative (MSQC).
Patients undergoing ostomy creation surgery between 2006-2011.
Main outcome measures
We evaluated hospitals' morbidity and mortality rates after risk-adjustment (age, comorbidities, emergency v. elective, procedure type).
4,250 patients underwent ostomy creation surgery; 3,866 (91.0%) procedures were open and 384 (9.0%) were laparoscopic. Unadjusted morbidity and mortality rates were 43.9% and 10.7%, respectively. Unadjusted morbidity rates for specific procedures ranged from 32.7% for ostomy-creation-only procedures to 47.8% for Hartmann's procedures. Risk-adjusted morbidity rates varied significantly between hospitals, ranging from 31.2% (95%CI 18.4-43.9) to 60.8% (95%CI 48.9-72.6). There were five statistically-significant high-outlier hospitals and three statistically-significant low-outlier hospitals for risk-adjusted morbidity. The pattern of complication types was similar between high- and low-outlier hospitals. Case volume, operative duration, and use of laparoscopic surgery did not explain the variation in morbidity rates across hospitals.
Morbidity and mortality rates for modern ostomy surgery are high. While this type of surgery has received little attention in healthcare policy, these data reveal that it is both common and uncommonly morbid. Variation in hospital performance provides an opportunity to identify quality improvement practices that could be disseminated among hospitals.
PMCID: PMC4197143  PMID: 24819104
stoma care; ostomy surgery; ostomy complications; surgical collaborative
3.  The timing of ostomy closure in infants with necrotizing enterocolitis: a systematic review 
Pediatric Surgery International  2012;28(7):667-672.
The optimal timing of ostomy closure is a matter of debate. We performed a systematic review of outcomes of early ostomy closure (EC, within 8 weeks) and late ostomy closure (LC, after 8 weeks) in infants with necrotizing enterocolitis.
PubMed, EMbase, Web-of-Science, and Cinahl were searched for studies that detailed time to ostomy closure, and time to full enteral nutrition (FEN) or complications after ostomy closure. Patients with Hirschsprung’s disease or anorectal malformations were excluded. Analysis was performed using SPSS 17 and RevMan 5.
Of 778 retrieved articles, 5 met the inclusion criteria. The median score for study quality was 9 [range 8–14 on a scale of 0 to 32 points (Downs and Black, J Epidemiol Community Health 52:377–384, 1998)]. One study described mean time to FEN: 19.1 days after EC (n = 13) versus 7.2 days after LC (n = 24; P = 0.027). Four studies reported complication rates after ostomy closure, complications occurred in 27 % of the EC group versus 23 % of the LC group. The combined odds ratio (LC vs. EC) was 1.1 [95 % CI 0.5, 2.5].
Evidence that supports early or late closure is scarce and the published articles are of poor quality. There is no significant difference between EC versus LC in the complication rate. This systematic review supports neither early nor late ostomy closure.
PMCID: PMC3376257  PMID: 22526553
Ostomy closure; Complications; Infants; Necrotizing enterocolitis; Systematic review
4.  Small Bowel Obstruction Following Restorative Proctocolectomy: Affected by a Laparoscopic Approach? 
The Journal of Surgical Research  2011;170(2):202-208.
Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the gold standard surgical treatment for chronic ulcerative colitis. More recently, this procedure is being performed laparoscopically assisted. Postoperatively, small bowel obstruction (SBO) is one of the more common associated complications. However, it is unknown whether the addition of a laparoscopic approach has changed this risk. This study aims to assess and compare the incidence of SBOs after both open and laparoscopic restorative proctocolectomy.
All subjects who underwent restorative proctocolectomy from 1998–2008 were identified from a prospective Colorectal Surgery Database. Medical records were reviewed for all cases of SBO, confirmed by a combination of clinical symptoms and radiologic evidence. Comparisons were made between laparoscopic and open approaches. The incidence of SBO was also subdivided into pre-ileostomy takedown, early post-ileostomy takedown (30 d post), and late post-ileostomy takedown (30 d to 1 y post). Several potential risk factors were also evaluated. Statistical analysis was performed utilizing Fisher’s exact (for incidence) or t-tests (for means). Significance was defined as P < 0.05
A total of 290 open cases and 100 laparoscopic cases were identified during this time period. The overall incidence of SBO at 1 y post-ileostomy takedown was 14% (n = 42) in the open group and 16% (n = 16) laparoscopic (P = NS). In the pre-ileostomy takedown period the incidence of SBO was 7% (n = 21) open and 13% (n = 13) laparoscopic (P = NS). While in the post-takedown period, the early incidence was 4% (n = 12) open and 1% (n = 1) laparoscopic and late incidence was 3% (n = 9) open and 2% (n = 2) laparoscopic (P = NS). Factors associated with an increased risk of SBO include coronary artery disease, prior appendectomy and W and J pouch configurations.
The burden of postoperative small bowel obstruction after restorative proctocolectomy is not changed with a laparoscopic approach. Most cases occur in the early postoperative period, especially prior to ileostomy reversal.
PMCID: PMC3326606  PMID: 21474147
proctocolectomy; IPAA; ileal pouch; small bowel obstruction
5.  Clinical profile and post-operative lifestyle changes in cancer and non-cancer patients with ostomy 
The aim of this was to investigate some clinical profiles and lifestyle changes in stoma patients.
Stoma patients experienced multiple complications due to their ostomy formation.
Patients and methods
A cross-sectional study performed on 102 random samples of stoma patients. Any patient with adequate physical and mental capability to participate and having had an ostomy in place for at least 3 months was eligible to enter the study. Participants asked to answer study questions concerning age, sex, type of stoma, having permanent or temporary ostomy, underlying cause of stoma formation, type of cancers cause of stoma. Patient also questioned about some lifestyle changes because of stoma including: changing diet, sexual satisfaction (if sexually active after stoma formation), sense of depression, changing job, change clothing style.
Colostomy was the most common type of stoma followed by ileostomy and urostomy. In 80.4% of patients under study the stoma was permanent. Most patients had a stoma because of cancer (77.5%), with colon cancer (41.2%) being the most common malignant diagnosis. The mean age of cancer patients (56.1±10.9) with stoma was significantly higher than non-cancer patients (44.7±12.9) (p < 0.05). A significant differences were found regarding to sexual satisfaction after stoma formation between the two groups (p < 0.05) and the cancer group was less sexually satisfied post-ostomy.
In conclusion, stoma formation can caused multiple problems for both cancer and non-cancer patients. Counseling of patient is an important component of care that could help stoma patients to adjust with new situations.
PMCID: PMC4017481  PMID: 24834234
Ostomy; Cancer; Life style
6.  Quality of Life Outcomes in Patients Living with Stoma 
Indian Journal of Palliative Care  2012;18(3):176-180.
Despite efforts to maintain the intestinal tissue and treat gastrointestinal disease, a large number of patients undergo ostomy surgery each year. Using stoma reduces the patient's quality of life (QOL) greatly. Although there are approximately 3000 patients in Iran; there is little information about the impact of stoma on their QOL.
The study aims to evaluate QOL of stoma patients using a special measurement tool.
Settings and Design:
This survey was a cross-sectional study that was conducted on 102 random samples of stoma patients.
Materials and Methods:
The City of Hope Quality of Life-Ostomy Questionnaire was used for collecting demographic and clinical information and evaluating QOL.
Statistical Analysis Used:
Univariate and multiple regression analyses were performed to identify predictors of QOL.
The mean score for the overall QOL for stoma patients was 7.48 ± 0.9. 70% of patients were dissatisfied with sexual activities. More than half of them reported feelings of depression following stoma surgery. Univariate analysis indicated that factors such as the type of ostomy (temporary/permanent), the underlying disease that had led to the stoma, depression, problem with location of ostomy, and change in clothing style had significant effects on overall QOL and its subscales (P < 0.05). The results of the regression analyses showed that only depression and problem with the location of ostomy were statistically significant in predicting patients’ QOL and its subscales (P < 0.05).
The findings demonstrated that living with stoma influences the overall aspect of QOL. Education for the patients and their families is important for improving the stoma patients’ QOL. Sexual and psychological consultation may also improve patients’ QOL.
PMCID: PMC3573471  PMID: 23439841
Depression; Ostomy; Quality of life; Sexual activity
7.  A study of laparoscopic extraperitoneal sigmoid colostomy after abdomino-perineal resection for rectal cancer 
Gastroenterology Report  2014;2(1):58-62.
Objective: To established a procedure for laparoscopic extraperitoneal ostomy after abdomino-perineal resection (APR) and study safety aspects and complications.
Method: From July 2011 to July 2012, 36 patients with low rectal cancer undergoing APR were included in the study and divided into extraperitoneal ostomy group (n = 18) and intraperitoneal ostomy group (n = 18). Short- and long-term complications were compared between the two groups. All patients were followed up and the median duration was 17 months (range: 12–24).
Results: The rates of short-term complication related to colostomies were comparable between the two groups, except the rate for stoma edema was higher in the extraperitoneal group (33.3% vs 0%; P = 0.008). In the intraperitoneal ostomy group, two patients developed stoma prolapse, one had stoma stenosis, and two had parastomal hernia. In contrast, no long-term complications related to colostomies occurred in the extraperitoneal ostomy group. The rate of long-term complication was lower in the extraperitoneal ostomy group (0% vs 22.2%; P = 0.036).
Conclusion: The laparoscopic extraperitoneal ostomy is a relatively simple and safe procedure, with fewer long-term complications related to colostomy. However the follow-up period was not too long and needs to be extended.
PMCID: PMC3920995  PMID: 24760238
rectal cancer; abdomino-perineal resection (APR); laparoscopy; extraperitoneal ostomy; complication
8.  Is Minimally Invasive Colon Resection Better Than Traditional Approaches? 
JAMA surgery  2014;149(2):177-184.
Minimally invasive colectomies are increasingly popular options for colon resection.
To compare the perioperative outcomes and costs of robot-assisted colectomy (RC), laparoscopic colectomy (LC), and open colectomy (OC).
The US Nationwide Inpatient Sample database was used to examine outcomes and costs before and after propensity score matching across the 3 surgical approaches. This study involved a sample of US hospital discharges from 2008 to 2010 and all patients 21 years of age or older who underwent elective colectomy.
In-hospital mortality, complications, ostomy rates, conversion to open procedure, length of stay, discharge disposition, and cost.
Of the 244 129 colectomies performed during the study period, 126 284 (51.7%) were OCs, 116 261 (47.6%) were LCs, and 1584 (0.6%) were RCs. In comparison with OC, LC was associated with a lower mortality rate (0.4%vs 2.0%), lower complication rate (19.8%vs 33.2%), lower ostomy rate (3.5 vs 13.0%), shorter median length of stay (4 vs 6 days), a higher routine discharge rate (86.1%vs 68.4%), and lower overall cost than OC ($11 742 vs $13 666) (all P < .05). Comparison between RC and LC showed no significant differences with respect to in-hospital mortality (0.0%vs 0.7%), complication rates (14.7%vs 18.5%), ostomy rates (3.0% vs 5.1%), conversions to open procedure (5.7%vs 9.9%), and routine discharge rates (88.7%vs 88.5%) (all P > .05). However, RC incurred a higher overall hospitalization cost than LC ($14 847 vs $11 966, P < .001).
In this nationwide comparison of minimally invasive approaches for colon resection, LC demonstrated favorable clinical outcomes and lower cost than OC. Robot-assisted colectomy was equivalent in most clinical outcomes to LC but incurred a higher cost.
PMCID: PMC4036435  PMID: 24352653
9.  Combined laparoscopic cholecystectomy with ileostomy reversal: A method of delayed definitive management of postoperative gallstone pancreatitis 
Traditional management of gallstone pancreatitis (GP) has been to perform cholecystectomy during the same hospital admission after resolution. However, when GP develops in the immediate postoperative period from a major colorectal operation, cholecystectomy may be fraught with difficulty due to the inflammatory response that occurs. Thus, delaying cholecystectomy until the inflammatory response subsides may be worthwhile, and it maximizes the chances of completing the cholecystectomy laparoscopically. We have described our management of 2 patients with GP occurring after colorectal operations, which required proximal diverting ileostomy. In both cases, we deferred management of GP with either endoscopic retrograde cholangiopancreatography (ERCP) or medical conservative measures during the acute attack and performed laparoscopic cholecystectomy during ostomy reversal surgery utilizing the existing ostomy takedown site for port placement. Both patients tolerated this management well.
PMCID: PMC3902562  PMID: 24501512
Colorectal resection; gall stone pancreatitis; ileostomy; laparoscopic cholecystectomy
10.  Intestinal Adaptation Following Small Bowel Resection in Human Infants 
Journal of pediatric surgery  2011;46(6):1045-1051.
In animal models, the small intestine responds to massive small bowel resection (SBR) through a compensatory process termed adaptation, characterized by increases in both villus height and crypt depth. This study seeks to determine whether similar morphologic alterations occur in humans following SBR.
Clinical data and pathologic specimens of infants who had both a SBR for necrotizing enterocolitis (NEC) and an ostomy takedown from 1999–2009 were reviewed. Small intestine mucosal morphology was compared in the same patients at the time of SBR and the time of ostomy takedown.
For all samples, there was greater villus height (453.6±20.4 vs. 341.2±12.4 μm, p<0.0001) and crypt depth (178.6±7.2 vs. 152.6±6 μm, p<0.01) in the ostomy specimens compared to the SBR specimens. In infants with paired specimens, there was an increase of 31.7±8.3% and 22.1±10.0% in villus height and crypt depth, respectively. There was a significant correlation between the amount of intestine resected and the percent change in villus height (r=0.36, p<0.05).
Mucosal adaptation after SBR in human infants is similar to what is observed in animal models. These findings validate the use of animal models of SBR utilized to understand the molecular mechanisms of this important response.
PMCID: PMC3121576  PMID: 21683196
small intestine; adaptation; small bowel resection; adaptation in humans
11.  Gastrointestinal ostomies and sexual outcomes: a comparison of colorectal cancer patients by ostomy status 
Research examining effects of ostomy use on sexual outcomes is limited. Patients with colorectal cancer were compared on sexual outcomes and body image based on ostomy status (never, past, and current ostomy). Differences in depression were also examined.
Patients were prospectively recruited during clinic visits and by tumor registry mailings. Patients with colorectal cancer (N = 141; 18 past ostomy; 25 current ostomy; and 98 no ostomy history) completed surveys assessing sexual outcomes (medical impact on sexual function, Female Sexual Function Index, International Index of Erectile Function), body image distress (Body Image Scale), and depressive symptoms (Center for Epidemiologic Studies Depression Scale—Short Form). Clinical information was obtained through patient validated self-report measures and medical records.
Most participants reported sexual function in the dysfunctional range using established cut-off scores. In analyses adjusting for demographic and medical covariates and depression, significant group differences were found for ostomy status on impact on sexual function (p <.001), female sexual function (p =.01), and body image (p <.001). The current and past ostomy groups reported worse impact on sexual function than those who never had an ostomy (p <.001); similar differences were found for female sexual function. The current ostomy group reported worse body image distress than those who never had an ostomy (p <.001). No differences were found across the groups for depressive symptoms (p =.33) or male sexual or erectile function (p values≥.59).
Colorectal cancer treatment puts patients at risk for sexual difficulties and some difficulties may be more pronounced for patients with ostomies as part of their treatment. Clinical information and support should be offered.
PMCID: PMC3967444  PMID: 24091721
Colorectal cancer; Oncology; Gastrointestinal ostomies; Sexual function; Body image
12.  Early closure of temporary ileostomy—the EASY trial: protocol for a randomised controlled trial 
BMJ Open  2011;1(1):e000162.
The objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal).
Reversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7–9% and minor complications varying from 4–5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality.
Design and methods
Early closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group ( and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0–12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation).
The aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome.
Clinical trials identifier
Article summary
Article focus
Frequency of complications 0–12 months after initial surgery; comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6, and 12 months after surgery (stoma creation); and comparison of the total costs of the two groups at 6 and 12 months after the initial surgery (stoma creation).
Key messages
The significance of the study is the aim of making evidence-based recommendations for timing of the closure of a temporary ileostomy after surgery for rectal cancer.
Strengths and limitations of the study
The dimensions of the study (sample size: 200 patients) allow us to make recommendations. The recommendations will be of central importance to future patients. The results not only incorporate complications and mortality but integrate patient-reported outcome. The limitation is that the follow-up period is limited to 12 months.
PMCID: PMC3191573  PMID: 22021780
13.  Quality of life in ostomy patients: a qualitative study 
Therapeutic procedures may not only treat disease but also affect patient quality of life. Therefore, quality of life should be measured in order to assess the impact of disease and therapeutic procedures. To identify clients’ problems, it is necessary to assess several dimensions of quality of life, including physical, spiritual, economic, and social aspects. In this regard, we conducted a qualitative study to explore quality of life and its dimensions in ostomy patients referred to the Iranian Ostomy Association.
Fourteen patients were interviewed about their quality of life dimensions by purposeful sampling. Data were gathered by semistructured interviews and analyzed using the content analysis method.
Nine main themes emerged using this approach, including physical problems related to colostomy, impact of colostomy on psychological functioning, social and family relationships, travel, nutrition, physical activity, and sexual function, as well as religious and economic issues.
The findings of the study identified a number of challenges in quality of life for patients with ostomy. The results can be used by health care providers to create a supportive environment that promotes better quality of life for their ostomy patients.
PMCID: PMC3034300  PMID: 21311696
ostomy; colostomy; qualitative study; quality of life
14.  Untreated Peristomal Skin Complications among Long-Term Colorectal Cancer Survivors with Ostomies: Lessons from a Study of Family Caregiving 
This ethnography of family caregiving explored why peristomal skin complications are both common and undertreated among colorectal cancer (CRC) survivors with intestinal ostomies. We sought to identify factors that hinder or facilitate prompt detection and treatment of ostomy and skin problems. We collected data through in-depth interviews with 31 cancer survivors and their family caregivers, fieldwork, structured assessments, and medical records review. We analyzed data using qualitative theme and matrix analyses. We found that survivors who received help changing the skin barrier around their stoma had fewer obstacles to detection and treatment of peristomal skin complications. Half of the survivors received unpaid help with ostomy care. All such help came from spouses. Married couples who collaborated in ostomy care reported that having assistance in placing the ostomy appliance helped with preventing leaks, detecting skin changes, and modifying ostomy care routines. Survivors who struggled to manage ostomy care independently reported more obstacles to alleviating and seeking treatment for skin problems. Nurses who encounter CRC survivors with ostomies can improve treatment of peristomal skin problems by asking patients and caregivers about ostomy care and skin problems, examining the peristomal area, and facilitating routine checkups with a wound, ostomy and continence nurse.
PMCID: PMC4123754  PMID: 22119975
surgical stomas; family caregivers; ethnography; colorectal neoplasms; long-term survivors
15.  Management of parastomal ulcers 
Management of surgically placed ostomies is an important aspect of any general surgical or colon and rectal surgery practice. Complications with surgically placed ostomies are common and their causes are multifactorial. Parastomal ulceration, although rare, is a particularly difficult management problem. We conducted a literature search using MD Consult, Science Direct, OVID, Medline, and Cochrane Databases to review the causes and management options of parastomal ulceration. Both the etiology and treatments are varied. Different physicians and ostomy specialists have used a large array of methods to manage parastomal ulcers; these including local wound care; steroid creams; systemic steroids; and, when conservative measures fail, surgery. Most patients with parastomal ulcers who do not have associated IBD or peristomal pyoderma gangrenosum (PPG) often respond quickly to local wound care and conservative management. Patients with PPG, IBD, or other systemic causes of their ulceration need both systemic and local care and are more likely to need long term treatment and possibly surgical revision of the ostomy. The treatment is complicated, but improved with the help of ostomy specialists.
PMCID: PMC4087953  PMID: 16718830
Parastomal ulcers; Peristomal ulcers; Ostomies; Complications
16.  Struggles, strengths, and strategies: an ethnographic study exploring the experiences of adolescents living with an ostomy 
Adolescents with IBD requiring ostomy surgery experience perioperative needs that may exceed those of patients experiencing other major abdominal surgery [1]. This procedure requires ongoing and vigilant daily care and management. Gastrointestinal symptoms and complications impose psychological and social stresses on young patients [2], and the procedure results in body image changes and daily regimens of self-care. This study aimed to explore adolescents' experiences and quality of life following ostomy surgery.
Ethnographic interviews and a subsequent focus group were conducted with 20 adolescents with an ostomy or j-pouch being treated at the Hospital for Sick Children in Toronto, Canada. Interviews were transcribed verbatim and subjected to theme generation.
Findings suggest that adolescents are profoundly affected by their ostomy. Adolescents convey strength as well as adjustment struggles. Identified impacts include body intrusion and body image changes, decreased independence, secrecy about the ostomy, adjustment over time, challenges for the family, and strategies for constructively moving forward.
Implications address the importance of ensuring meaningful opportunities to understand and reframe the stresses of illness. An ongoing clinical challenge involves the promotion of a healthy self-esteem and psychosocial adjustment for these adolescents and their families. Finding effective ways to minimize stress and embarrassment and reframe personal shame, constitute important clinical priorities. Opportunities for peer support and family dialogue may assist in clarifying worries and easing the burden carried by these young persons. Flexible and adequately funded resources are advocated in fostering quality of life.
PMCID: PMC2626588  PMID: 19091104
Diseases of the Colon and Rectum  2010;53(2):200-212.
Among long-term (≥5 years) colorectal cancer survivors with permanent ostomy or anastomosis, we compared the incidence of medical and surgical complications and examined the relationship of complications with health-related quality of life.
The incidence and effects of complications on long-term health-related quality of life among colorectal cancer survivors are not adequately understood.
Participants (284 ostomy/395 anastomosis) were long-term colorectal cancer survivors enrolled in an integrated health plan. Health-related quality of life was assessed via mailed survey questionnaire in 2002–2005. Information on colorectal cancer, surgery, co-morbidities, and complications was obtained from computerized data and analyzed using survival analysis and logistic regression.
Ostomy and anastomosis survivors were followed an average 12.1 and 11.2 years, respectively. Within 30 days of surgery, 19% of ostomy and 10% of anastomosis survivors experienced complications (p<0.01). From 31 days on, the percentages were 69% and 67% (after adjustment, p<0.001). Bleeding and post-operative infection were common early complications. Common long-term complications included hernia, urinary retention, hemorrhage, skin conditions, and intestinal obstruction. Ostomy was associated with long-term fistula (odds ratio 5.4; 95% CI 1.4–21.2), and among ostomy survivors, fistula was associated with reduced health-related quality of life (p<0.05).
Complication rates remain high despite recent advances in surgical treatment methods. Survivors with ostomy have more complications early in their survivorship period, but complications among anastomosis survivors catch up after 20 years, when the two groups have convergent complication rates. Among colorectal cancer survivors with ostomy, fistula has especially important implications for health-related quality of life.
PMCID: PMC3320086  PMID: 20087096
18.  Correction of Skin Contour Defects in Leaking Stomas by Filler Injection: A Novel Approach for a Difficult Clinical Problem 
Dermatology and Therapy  2014;4(2):271-279.
Stomal leaks can be associated with significant social, psychological and physical morbidity for ostomy patients. Poor fitting of the stoma appliance due to irregularities of skin contours is one cause of stoma leaks which commonly result in secondary irritant dermatitis prompting presentation to a dermatologist. In addition to skin-directed topical therapy and review of stoma appliances, correction of contour defects with intradermal injections of filler materials is one possible treatment to improve adhesion and reduce leaks.
We report eight cases of ostomy patients, who presented with stoma leaks and associated dermatitis, who were treated with intradermal injections of the porcine collagen (Permacol™) or subcutaneous injections of polyacrylamide hydrogel (Aquamid Reconstruction™) for correction of skin contour defects. Resolution or improvement of symptoms was achieved for five patients, and no complications were noted as a result of treatment.
This report represents the largest series of ostomy patients treated for correction of peristomal skin contour defects with injection therapy. Treatment was well tolerated and performed in the outpatient setting under local anesthetic. Attempted correction of peristomal skin contour defects using injection of filler materials represents a potential alternative to surgical intervention and can result in significant benefits for the patient.
Electronic supplementary material
The online version of this article (doi:10.1007/s13555-014-0058-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4257946  PMID: 25005352
Collagen; Colostomy; Filler; Ileostomy; Polyacrylamide hydrogel; Porcine collagen; Stoma; Urostomy
19.  Patient Preferences for Surgical Versus Medical Therapy for Ulcerative Colitis 
Inflammatory bowel diseases  2014;20(1):103-114.
Therapy options for mesalamine-refractory ulcerative colitis (UC) include immunosuppressive medications or surgery. Chronic immunosuppressive therapy increases risks of infection and cancer, whereas surgery produces a permanent change in bowel function. We sought to quantify the willingness of patients with UC to accept the risks of chronic immunosuppression to avoid colectomy.
We conducted a state-of-the-art discrete-choice experiment among 293 patients with UC who were offered a choice of medication or surgical treatments with different features. Random parameters logit was used to estimate patients’ willingness to accept trade-offs among treatment features in selecting surgery versus medical treatment.
A desire to avoid surgery and the surgery type (ostomy versus J-pouch) influenced patients’ choices more than a specified range of 10-year mortality risks from lymphoma or infection, or disease activity (mild versus remission). To avoid an ostomy, patients were willing to accept a >5% 10-year risk of dying from lymphoma or infection from medical therapy, regardless of medication efficacy. However, data on patients’ stated choice indicated perceived equivalence between J-pouch surgery and incompletely effective medical therapy. Patient characteristics and disease history influenced patients’ preferences regarding surgery versus medical therapy.
Patients with UC are willing to accept relatively high risks of fatal complications from medical therapy to avoid a permanent ostomy and to achieve durable clinical remission. However, patients view J-pouch surgery, but not permanent ileostomy, as an acceptable therapy for refractory UC in which medical therapy is unable to induce a durable remission.
PMCID: PMC4137889  PMID: 24280881
inflammatory bowel disease; IBD; DCE; maximum acceptable risk
20.  Changes in Body Mass Index and Stoma Related Problems in the Elderly 
Journal of geriatric oncology  2012;4(1):84-89.
Weight gain can cause retraction of an intestinal stoma, possibly resulting in difficulty with wafer and pouch fit, daily care challenges, and discomfort. This cross-sectional study examined the association between body mass index (BMI) and ostomy-related problems among long-term (>5 years post-diagnosis) colorectal cancer (CRC) survivors.
Materials and Methods
CRC survivors from three Kaiser Permanente Regions completed a mailed survey. The response rate for those with an ostomy was 53% (283/529). Questions included stoma-related problems and time to conduct daily ostomy care. Poisson regression evaluated associations between report of problems and change in BMI. Our analysis sample included 235 survivors.
Sample was 76% ≥65 years of age. Since their surgeries, BMI remained stable in 44% (ST), decreased in 20% (DE), and increased in 35% (IN) of survivors. Compared to ST, male IN (RR 2.15 [1.09–4.25]) and female DE (RR 5.06 [1.26–25.0]) were more likely to spend more than 30 minutes per day on stoma care. IN (vs. ST) were more likely to report interference with clothing (RR 1.51 [1.06–2.17]) and other stoma-related problems (RR 2.32 [1.30–4.14]). Survivors who were obese at time of survey were more likely to report interference with clothing (RR 1.88 [1.38–2.56]) and other stoma-related problems (RR 1.68 [1.07–2.65]).
A change in BMI is associated with ostomy-related problems among long-term CRC survivors. Equipment and care practices may need to be adapted for changes in abdominal shape. Health care providers should caution that a significant increase or decrease in BMI may cause ostomy-related problems.
PMCID: PMC3564631  PMID: 24071496
Colorectal cancer; ostomy; stoma; BMI; body mass index
21.  The Impact of Ileostomy-Related Complications on the Multidisciplinary Treatment of Rectal Cancer 
Annals of surgical oncology  2013;21(2):507-512.
Radical resection is the primary treatment for rectal cancer. When anastomosis is possible, a temporary ileostomy is used to decrease morbidity from a poorly healed anastomosis. However, ileostomies are associated with complications, dehydration, and need for a second operation. Our purpose was to evaluate the impact of ileostomy related complications on the treatment of rectal cancer.
A retrospective cohort study of patients who underwent sphincter preserving surgery between January 2005 and December 2010 at a tertiary cancer center. The primary outcome was the overall rate of ileostomy related complications. Secondary outcomes included complications related to ileostomy status, ileostomy closure, anastomotic complications at primary resection, rate of stoma closure, and completion of adjuvant chemotherapy. Statistical analyses were performed with STATA 12.
A total of 294 patients were analyzed, 32% (n=95) were women. Two hundred seventy-one (92%) received neoadjuvant chemoradiation. The median tumor distance from the anal verge was 7 centimeters (interquartile range 5-10). Two hundred eighty-one (96%) underwent stoma closure at a median 7 months (interquartile range 5.4 – 8.3). The most common complication related to readmission was dehydration (n=32, 11%). Readmission within 60 days of primary resection was associated with delay in initiating adjuvant chemotherapy (OR 3.01, 95% CI 1.42-6.38, p=0.004).
Diverting ileostomies created during surgical treatment of rectal cancers are associated with morbidity; however this is balanced against the risk of anastomosis-related morbidity at rectal resection. Given the potential benefit of fecal diversion, patient-oriented interventions to improve ostomy management, particularly during adjuvant chemotherapy, can be expected to yield marked benefits.
PMCID: PMC4026258  PMID: 24085329
22.  Triple-Tube-Ostomy: A Novel Technique for the Surgical Treatment of Iatrogenic Duodenal Perforation 
Case Reports in Gastroenterology  2011;5(3):672-679.
Although duodenal perforation is currently an infrequent complication of medical procedures, its incidence in the future predictably will increase as endoscopic treatment of duodenal neoplasms becomes more frequently used. In some cases, duodenal perforation is difficult to treat even surgically. We report here a novel technique called ‘triple-tube-ostomy’ for the treatment of iatrogenic duodenal perforation. Since November 2009, there have been three cases of iatrogenic perforation of the duodenum, due to various causes, which we have treated with our novel technique. The main principles of the technique are biliary diversion, decompression of the duodenum, and early enteral nutrition. All patients who underwent the triple-tube-ostomy procedure had good postoperative courses, with few complications. The novel surgical technique we describe in this report is safe, reliable, easy to learn and perform, and led to a good postoperative course in all cases where we performed it.
PMCID: PMC3254034  PMID: 22235196
Duodenal perforation; Endoscopy; Postoperative course
23.  The Role of Surgery in the Management of Patients With Refractory Chronic Granulomatous Disease Colitis 
Diseases of the colon and rectum  2013;56(5):609-614.
Chronic granulomatous disease is a rare immunodeficiency complicated by dysregulated inflammation and granulomatous complications of the gastrointestinal tract. The management of chronic granulomatous disease colitis presents the dilemma of an immunocompromised host requiring immunosuppressive therapy which can potentiate fatal infections.
To identify the types of gastrointestinal surgery performed in patients and determine the role of surgery in the management of refractory colitis.
Design and Settings
A retrospective single institution chart review was performed.
Of 268 patients with chronic granulomatous disease treated at the National Institutes of Health between 1985 and 2011, 98 (37%) were identified as having colitis; 27 (10%) had a history of gastrointestinal luminal surgery.
Main outcome measures
Patient characteristics, type of gastrointestinal surgery and clinical outcomes were documented.
A total of 62 gastrointestinal luminal surgeries were performed in 27 patients with chronic granulomatous disease and colitis. All 27 had a history of perineal disease requiring intervention. Four (15%) had additional surgery performed for reasons other than colitis. Otherwise, 12 (44%) had surgery limited to the perineum, 2 (7%) had a segmental resection and 13 (48%) underwent fecal diversion with ileostomy or colostomy. Despite local procedures, 7 (58%) patients in the perineal only group remained symptomatic. Both patients with a segmental resection had persistent perineal disease and 1 had a recurrent colovesicular fistula. Of the 13 ostomy patients, 11 initially received a diverting ostomy. Eight (73%) of these ultimately required additional procedures for refractory disease and 4 (36%) developed peristomal pyoderma gangrenosum. Four patients who underwent proctocolectomy with end ileostomy, either initially (2) or as a definitive procedure (2), experienced resolution of colitis and perineal disease.
This study is limited by its retrospective design, small sample size and highly selected patient population.
Proctocolectomy with end ileostomy may offer a definitive treatment in a patient with refractory chronic granulomatous disease colitis given current therapeutic limitations.
PMCID: PMC3624095  PMID: 23575400
chronic granulomatous disease; colitis; surgical management
24.  Laparoscopy Improves Short-term Outcomes After Surgery for Diverticular Disease 
Gastroenterology  2010;138(7):2267-2274.e1.
Observational studies and small randomized controlled trials have shown that the use of laparoscopy in colon resection for diverticular disease is feasible and results in fewer complications. We analyzed data from a large, prospectively maintained, multicenter database (National Surgical Quality Initiative Program) to determine whether the use of laparoscopy in the elective treatment of diverticular disease decreases rates of complications compared with open surgery, independent of preoperative comorbid factors.
The analysis included data from 6970 patients who underwent elective surgeries for diverticular disease from 2005 to 2008. Patients with diverticular disease were identified by International Classification of Diseases, 9th revision codes and then categorized into open or laparoscopic groups based on Current Procedural Terminology codes. Preoperative, intraoperative, and postoperative data were analyzed to determine factors associated with increased risk for postoperative complications.
Data were analyzed from 3468 patients who underwent open surgery and 3502 patients who underwent laparoscopic procedures. After correcting for probability of morbidity, American Society of Anesthesiology class, and ostomy creation, overall complications (including superficial surgical site infections, deep incisional surgical site infections, sepsis, and septic shock) occurred with significantly lower incidence among patients who underwent laparoscopic procedures compared with those who received open operations.
The use of laparoscopy for treating diverticular disease, in the absence of absolute contraindications, results in fewer postoperative complications compared with open surgery.
PMCID: PMC3371380  PMID: 20193685
Diverticulitis; Outcomes; Colectomy; Colorectal Surgery
25.  Dietary Patterns and Self-Reported Associations of Diet with Symptoms of Inflammatory Bowel Disease 
Digestive diseases and sciences  2012;58(5):1322-1328.
There are insufficient data to make firm dietary recommendations for patients with inflammatory bowel disease (IBD). Yet patients frequently report that specific food items influence their symptoms. In this study, we describe patients’ perceptions about the benefits and harms of selected foods and patients’ dietary patterns.
CCFA Partners is an ongoing internet-based cohort study of patients with IBD. We used a semi-quantitative food frequency questionnaire to measure dietary consumption patterns and open-ended questions to elicit responses from patients about food items they believe ameliorate or exacerbate IBD. We categorized patients into four mutually exclusive disease categories: CD without an ostomy or pouch (CD), UC without an ostomy or pouch (UC), CD with an ostomy (CD-ostomy), and UC with a pouch (UC-pouch).
Yogurt, rice, and bananas were more frequently reported to improve symptoms whereas non-leafy vegetables, spicy foods, fruit, nuts, leafy vegetables, fried foods, milk, red meat, soda, popcorn, dairy, alcohol, high-fiber foods, corn, fatty foods, seeds, coffee, and beans were more frequently reported to worsen symptoms. Compared to CD patients, CD-ostomy patients reported significantly greater consumption of cheese (odds ratio (OR) 1.56, 95% CI 1.03–2.36), sweetened beverages (OR 2.14, 95% CI 1.02–1.03), milk (OR 1.84, 95% CI 1.35–2.52), pizza (OR 1.57, 95% CI 1.12–2.20), and processed meats (OR 1.40; 95% CI 1.04–1.89).
Patients identified foods that they believe worsen symptoms and restricted their diet. Patients with ostomies ate a more liberal diet. Prospective studies are needed to determine whether diet influences disease course.
PMCID: PMC3552110  PMID: 22923336

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