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1.  Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study) 
BMC Surgery  2014;14:58.
Background
Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure.
Methods/Design
In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs.
Discussion
The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia.
Trail registration number
NCT01927497 (Clinicaltrial.gov).
doi:10.1186/1471-2482-14-58
PMCID: PMC4158342  PMID: 25163547
Abdominoperineal resection; Rectal cancer; Radiotherapy; Primary perineal wound closure; Biological mesh; perineal wound infection; Perineal wound healing
2.  Intentionally curative treatment of locally recurrent rectal cancer: a systematic review 
Canadian Journal of Surgery  2013;56(2):135-144.
Background
There is a lack of outcome data beyond local recurrence rates after primary treatment in rectal cancer, despite more information being necessary for clinical decision-making. We sought to determine patient selection, therapeutic modalities and outcomes of locally recurrent rectal cancer treated with curative intent.
Methods
We searched MEDLINE (1990–2010) using the medical subject headings “rectal neoplasms” and “neoplasm recurrence, local.” Selection of cohort studies was based on the primary intention of treatment and availability of at least 1 outcome variable.
Results
We included 55 cohort studies comprising 3767 patients; 8 studies provided data on the rate of intentionally curative treatment from an unselected consecutive cohort of patients (481 of 1188 patients; 40%). Patients were symptomatic with pain in 50% (796 of 1607) of cases. Overall, 3088 of 3767 patients underwent resection. The R0 resection rate was 56% (1484 of 2637 patients). The rate of external beam radiotherapy was 100% in 9 studies, 0% in 5 studies, and ranged from 12% to 97% in 37 studies. Overall postoperative mortality was 2.2% (57 of 2515 patients). Five-year survival was at least 25%, with an upper limit of 41% in 11 of 18 studies including at least 50 resections. We found a significant increase in reported survival rates over time (r2 = 0.214, p = 0.007).
Conclusion
More uniformity in treatment protocols and reporting on outcomes for locally recurrent rectal cancer is warranted. The observed improvement of reported survival rates in time is probably related to better patient selection and optimized multimodality treatment in specialized centres.
doi:10.1503/cjs.025911
PMCID: PMC3617119  PMID: 23517634
3.  The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery 
BMC Surgery  2011;11:34.
Background
The CARTS study is a multicenter feasibility study, investigating the role of rectum saving surgery for distal rectal cancer.
Methods/Design
Patients with a clinical T1-3 N0 M0 rectal adenocarcinoma below 10 cm from the anal verge will receive neoadjuvant chemoradiation therapy (25 fractions of 2 Gy with concurrent capecitabine). Transanal Endoscopic Microsurgery (TEM) will be performed 8 - 10 weeks after the end of the preoperative treatment depending on the clinical response.
Primary objective is to determine the number of patients with a (near) complete pathological response after chemoradiation therapy and TEM. Secondary objectives are the local recurrence rate and quality of life after this combined therapeutic modality. A three-step analysis will be performed after 20, 33 and 55 patients to ensure the feasibility of this treatment protocol.
Discussion
The CARTS-study is one of the first prospective multicentre trials to investigate the role of a rectum saving treatment modality using chemoradiation therapy and local excision. The CARTS study is registered at clinicaltrials.gov (NCT01273051)
doi:10.1186/1471-2482-11-34
PMCID: PMC3295682  PMID: 22171697
4.  Less adhesiolysis and hernia repair during completion proctocolectomy after laparoscopic emergency colectomy for ulcerative colitis 
Surgical Endoscopy  2011;26(2):368-373.
Background
The aim of this study was to determine whether the need for adhesiolysis during completion proctectomy (CP) with ileopouch anal anastomosis (IPAA) is influenced by the surgical approach of the initial emergency colectomy for ulcerative colitis and the hospital setting.
Methods
One hundred consecutive patients who underwent CP with IPAA in our center between January 1999 and April 2010 were included. Emergency colectomy had been performed laparoscopically in 30 of 52 patients at the Academic Medical Center Amsterdam and in 6 of 48 patients at referring hospitals. Case files of these patients were retrospectively reviewed.
Results
Significantly more extensive adhesiolysis was performed after open compared to laparoscopic colectomy (47 vs. 6%, P < 0.001). In univariate analysis, emergency colectomy at a referring hospital was also predictive for adhesiolysis (P = 0.003), but the open approach for the initial colectomy was the only independent predictive factor for the need for adhesiolysis (P < 0.001) in a multivariable ordinal logistic regression analysis. Operating time of CP was significantly longer when limited [18 (95% CI = 0–36) min] or extensive [55 (35–75) min] adhesiolysis had to be performed. The interval to CP was longer after open colectomy and after colectomy performed at a referring hospital. Significantly more incisional hernia corrections during CP were performed after open emergency colectomy (14 vs. 0%, P = 0.024). Overall morbidity and postoperative hospital stay of CP were not related to the surgical approach or the hospital setting of the emergency colectomy.
Conclusion
Laparoscopic as opposed to open emergency colectomy is associated with less adhesiolysis, fewer incisional hernias, and a shorter interval to completion proctectomy.
doi:10.1007/s00464-011-1880-1
PMCID: PMC3261391  PMID: 21993930
Restorative proctocolectomy; Ulcerative colitis; Abdominal adhesions; Laparoscopy; Incisional hernia
5.  Sexual and urinary functioning after rectal surgery: a prospective comparative study with a median follow-up of 8.5 years 
Purpose
The purpose of this study was to prospectively compare rectal resection (RR) with colonic resection on sexual, urinary and bowel function and quality of life in both short-term and long-term.
Methods
Eighty-three patients who underwent RR were compared to 53 patients who underwent a colonic resection leaving the rectum in situ (RIS). A questionnaire assessing sexual, urinary and bowel functioning with a quality of life questionnaire (SF-36) was sent to all participants preoperatively, 3 and 12 months postoperatively and approximately 8 years after the onset of the study.
Results
Short-term dysfunction included diminished sexual activity in female RR patients at 3 months and significantly more erectile dysfunction in RR patients 1 year postoperatively. Long-term dysfunction included more frequent and more severe erectile dysfunction in RR patients compared to RIS patients. These short-term and long-term outcomes did not influence overall quality of life. The incidence of urinary dysfunction was comparable between both groups. Bowel functioning was significantly better in the RIS group compared to the RR group 3 months and 1 year postoperatively.
Conclusions
Patients who underwent RR experienced up to 1 year postoperatively more sexual and bowel function problems than RIS patients. However, short-term and long-term dysfunction did not influence overall quality of life. Erectile dysfunction in male RR patients persisted in time, whereas other aspects of sexual, urinary and bowel function after RR and colonic resection are similar after a median follow-up of 8.5 years.
doi:10.1007/s00384-011-1288-3
PMCID: PMC3219871  PMID: 21922200
Rectal resection; Colonic resection; Sexual function; Urinary function; Bowel function
6.  Alternative specimen extraction techniques after laparoscopic emergency colectomy in inflammatory bowel disease 
Surgical Endoscopy  2011;26(2):408-412.
Background
Omitting the extraction site incision potentially further decreases the abdominal wall trauma in laparoscopic surgery. The purpose of this study was to report the results of alternative specimen extraction techniques after laparoscopic emergency colectomy in patients with inflammatory bowel disease (IBD).
Methods
Ten consecutive patients with IBD underwent (sub)acute emergency colectomy for refractory disease from October 2009 until December 2010. The specimen was retrieved via the stoma site in three and transrectally in seven patients. Patient data were prospectively collected. In case of later completion proctectomy and pouch procedure, adhesions were systematically scored.
Results
The extraction techniques were all feasible. Median operative time was 219 (interquartile range (IQR), 197–232) min. The pain scores and morphine requirement in patients decreased quickly after surgery. No infectious complications occurred. In five patients, a completion proctectomy was performed at a median time of 7 (IQR, 3.8–9.3) months after colectomy. All patients showed absence of any adhesions in the pelvis. In two patients, limited adhesions of the cut side of the mesentery were present.
Conclusions
Specimen extraction via the rectum or stoma site is a safe, alternative way to extract the specimen after laparoscopic colectomy. No infectious complications were observed postoperatively and no pelvic adhesions were found during completion proctectomy.
doi:10.1007/s00464-011-1888-6
PMCID: PMC3261408  PMID: 21909858
Colitis; Inflammatory bowel disease; Colectomy; Laparoscopy; Extraction
7.  Morbidity related to defunctioning ileostomy closure after ileal pouch-anal anastomosis and low colonic anastomosis 
Purpose
Defunctioning ileostomies are widely performed in order to prevent or treat anastomotic leakage after colorectal surgery. The aim of the present study was to determine morbidity related to stoma closure and to identify predictive factors of a complicated postoperative course.
Methods
A consecutive series of 138 patients were retrospectively analyzed after stoma reversal. Data collection included general demographics and surgery-related aspects. Morbidity related to stoma closure was retrieved from our prospectively collected registry of complications.
Results
In 74 of 138 patients, defunctioning ileostomy was performed after restorative proctocolectomy and ileal pouch-anal anastomosis (IPAA). The remaining ileostomies (n = 64) were constructed after a low colorectal or coloanal anastomosis. A total of 46 complications were recorded in 28 patients resulting in an overall complication rate of 20.3%. Anastomotic leakage rate was 4.3%, and reoperation rate was 8.0%. The number of complications according to the Clavien–Dindo classification was 5 for grade I (10.9%), 26 for grade II (56.5%), 13 for grade III (28.3%), 1 for grade IV (2.2%), and 1 for grade V (2.2%). Multivariate analysis revealed a significantly higher ASA score in the complicated group (P = 0.015, odds ratio 2.6, 95% confidence interval 1.2–5.6).
Conclusions
Closure of a defunctioning ileostomy is associated with 20% morbidity and a reoperation rate of 8%. There is an urgent need for criteria on which a more selective use of a defunctioning ileostomy after low colonic anastomosis or IPAA can be based given its associated morbidity.
doi:10.1007/s00384-011-1276-7
PMCID: PMC3249166  PMID: 21761119
Defunctioning ileostomy; Stoma; Ileostomy; Morbidity
8.  Surgical Treatment of Renal Cell Cancer Liver Metastases: A Population-Based Study 
Annals of Surgical Oncology  2011;18(7):1932-1938.
Background
To evaluate outcomes of surgical treatment in patients with hepatic metastases from renal-cell carcinoma in the Netherlands, and to identify prognostic factors for survival after resection. Renal-cell carcinoma has an incidence of 2,000 new patients in the Netherlands each year (12.5/100,000 inhabitants). According to literature, half of these patients ultimately develop distant metastases with 20% involvement of the liver. Resection of renal-cell carcinoma liver metastases (RCCLM) is performed in only a minority of patients. Hence, little is known about outcome of resectable RCCLM.
Methods
Patients were retrieved from local databases of theNetherlands Task Force for Liver Surgery (14 centers) and from the Dutch collective pathology database. Survival and prognostic factors were determined by Kaplan–Meier analysis and log rank test.
Results
Thirty-three patients were identified who underwent resection (n = 29) or local ablation (n = 4) of RCCLM in the Netherlands between 1990 and 2008. These patients comprise 0.5% to 1% of the total population of patients diagnosed with RCCLM in that period. There was no operative mortality. The overall survival at 1, 3, and 5 years was 79, 47, and 43%, respectively. Metachronous metastases (n = 23, P = 0.03) and radical resection (n = 19, P < 0.001) were statistically significant prognosticators of overall survival. Size < 50 mm (n = 18, P = 0,54), solitary metastases (n = 19, P = 0.93), and presence of extrahepatic metastases (n = 11, P = 0.28) did not have a statistically significant impact on survival.
Conclusions
The favorable 5-year survival rate of 43% without operative mortality as found in this nationwide study indicates that selected patients with RCCLM can benefit from surgical treatment.
doi:10.1245/s10434-010-1526-x
PMCID: PMC3115064  PMID: 21347794
9.  History of sentinel node and validation of the technique 
Breast Cancer Research  2001;3(2):109-112.
Sentinel node biopsy is a minimally invasive technique to select patients with occult lymph node metastases who may benefit from further regional or systemic therapy. The sentinel node is the first lymph node reached by metastasising cells from a primary tumour. Attempts to remove this node with a procedure based on standard anatomical patterns did not become popular. The development of the dynamic technique of intraoperative lymphatic mapping in the 1990s resulted in general acceptance of the sentinel node concept. This hypothesis of sequential tumour dissemination seems to be valid according to numerous studies of sentinel node biopsy with confirmatory regional lymph node dissection. This report describes the history and the validation of the technique, with particular reference to breast cancer.
doi:10.1186/bcr281
PMCID: PMC139441  PMID: 11250756
history; lymphatic dissemination; review; sentinel node

Results 1-9 (9)