Background Radical surgery via total mesorectal excision might not be the optimal first-line treatment for early-stage rectal cancer. An organ-preserving strategy with selective total mesorectal excision could reduce the adverse effects of treatment without substantially compromising oncological outcomes. We investigated the feasibility of recruiting patients to a randomised trial comparing an organ-preserving strategy with total mesorectal excision.Methods TREC was a randomised, open-label feasibility study done at 21 tertiary referral centres in the UK. Eligible participants were aged 18 years or older with rectal adenocarcinoma, staged T2 or lower, with a maximum diameter of 30 mm or less; patients with lymph node involvement or metastases were excluded. Patients were randomly allocated (1:1) by use of a computer-based randomisation service to undergo organ preservation with short-course radiotherapy followed by transanal endoscopic microsurgery after 8-10 weeks, or total mesorectal excision. Where the transanal endoscopic microsurgery specimen showed histopathological features associated with an increased risk of local recurrence, patients were considered for planned early conversion to total mesorectal excision. A non-randomised prospective registry captured patients for whom randomisation was considered inappropriate, because of a strong clinical indication for one treatment group. The primary endpoint was cumulative randomisation at 12, 18, and 24 months. Secondary outcomes evaluated safety, efficacy, and health-related quality of life assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30 and CR29 in the intention-to-treat population. This trial is registered with the ISRCTN Registry, ISRCTN14422743.
The current published literature supports the use of the rhomboid flap excision and the Limberg flap-repair procedures over primary midline suture techniques for the elective management of primary pilonidal disease. Further high-quality studies are necessary to compare flap with off-midline repairs.
Study characteristicsFollowing our data search in January 2018, we included 10 trials with a total of 844 participants, which we assessed using the standard Cochrane Review protocol. The trials compared the incidence of hernia development around a stoma between a group having a mesh placement at the time of stoma formation and a control group having a conventional stoma formation without mesh placement.
Key resultsWe found that mesh placement around the stoma at the time of stoma formation reduces the incidence of future hernia formation. The participants having a mesh fitted had a similar level of complications as those not having a mesh.
Quality of evidenceWe found low-quality evidence favouring the insertion of a mesh into people having a stoma.Prosthetic mesh placement for the prevention of parastomal herniation (Review)
, 1-12%). The rectal infiltration took the form of an anterior rectal mass with or without ulceration in 52%, an annular stricture in 45%, and separate metastasis in 3%. In 40% of patients, a preceding history of prostatic adenocarcinoma was elicited at the time of gastrointestinal presentation, while in 60% it was not elicited. In the study group, 26% of patients underwent surgery; the most commonly performed procedure was a defunctioning colostomy (18%) to alleviate symptoms of large bowel obstruction. Five patients underwent rectal resection because the pre-operative diagnosis was suspected to be primary rectal adenocarcinoma. The median survival was 15 months (95% confidence interval 14-16 months). Survival beyond 30 months was rare.
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