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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.  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
3.  Relationship satisfaction in couples confronted with colorectal cancer: the interplay of past and current spousal support 
Journal of Behavioral Medicine  2011;34(4):288-297.
Based on attribution theory, this study hypthesized that past spousal supportiveness may act as a moderator of the link between one partner’s current support behavior and the other partner’s relationship satisfaction. A sample of 88 patients with colorectal cancer and their partners completed questionnaires approximately 3 and 9 months after diagnosis. The data were analyzed employing dyadic data analytic approaches. In the short-term, spousal active engagement—which involved discussing feelings and engaging in joint problem solving—was positively associated with relationship satisfaction in patients as well as in partners, but only when past spousal support was relatively low. Spousal protective buffering—which involved hiding worries and fears and avoiding talking about the disease—was negatively associated with relationship satisfaction in patients, again only when past spousal support was relatively low. If past spousal support was high, participants rated the quality of their relationship relatively high, regardless of their partner’s current support behavior. Over time, past spousal supportiveness was not found to mitigate the negative association between spousal protective buffering and relationship satisfaction. Overall, our results indicate that relationship satisfaction can be maintained if past spousal supportiveness is high even if the partner is currently not very responsive to the individual’s needs, at least in the short-term.
doi:10.1007/s10865-010-9311-7
PMCID: PMC3141841  PMID: 21222025
Active engagement; Protective buffering; Marital quality; Attributions; Cancer; Longitudinal
4.  Elective laparoscopic recto-sigmoid resection for diverticular disease is suitable as a training operation 
Purpose
Some authors state that elective laparoscopic recto-sigmoid resection is more difficult for diverticular disease as compared with malignancy. For this reason, starting laparoscopic surgeons might avoid diverticulitis, making the implementation phase unnecessary long. The aim of this study was to determine whether laparoscopic resection for diverticular disease should be included during the implementation phase.
Methods
All consecutive patients who underwent an elective laparoscopic recto-sigmoid resection in our hospital for diverticulitis or cancer from 2003 to 2007 were analysed.
Results
A total of 256 consecutive patients were included in this prospective cohort study. One hundred and fifty-one patients were operated on for diverticulitis and 105 for cancer. There was no significant difference in operation time (168 vs. 172 min), blood loss (189 vs. 208 ml), conversion rates (9.9% vs. 11.4%), hospital stay (8 vs. 8 days), total number of peroperative (2.3% vs. 1.6%) or postoperative complications (21.9% vs. 26.9%). The occurrence of anastomotic leakages was associated with higher American Society of Anesthesiologists (ASA) classification, which differed between the groups (86.8% vs. 64.8% ASA I–II, p < 0.001).
Conclusion
Since there are no differences in operation time, blood loss, conversion rate and total complications, there is no need to avoid laparoscopic recto-sigmoid resection for diverticular disease early in the learning curve.
doi:10.1007/s00384-010-0875-z
PMCID: PMC2830626  PMID: 20145937
Laparoscopy; Colon cancer; Diverticular disease; Recto-sigmoid resection; Teaching; Malignancy
5.  Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study) 
BMC Surgery  2009;9:4.
Background
Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.
The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.
Methods/design
Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma ≥ 3 cm, located between 1–15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment.
Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures.
Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group.
Discussion
The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas.
Trial registration number
(trialregister.nl) NTR1422
doi:10.1186/1471-2482-9-4
PMCID: PMC2664790  PMID: 19284647

Results 1-5 (5)