Total colectomy with ileorectal anastomosis versus subtotal colectomy with cecal-rectal anastomosis for slow transit constipation: protocol for a multicenter randomized controlled trial (STOPS trial).

backgroundConstipation, a prevalent gastrointestinal disorder, affects 10%-15% of adults in the USA and approximately 8.2% of China's general population. Slow transit constipation (STC), accounting for 15%-42% of constipation cases, is defined by impaired colonic motility. For patients refractory to conservative treatment who experience chronic, intractable symptoms and diminished quality of life, surgical intervention becomes the treatment of last resort. The primary surgical approach for STC has traditionally been total colectomy with ileorectal anastomosis (TC-IRA). However, over the past two decades, subtotal colectomy with cecorectal anastomosis (SC-CRA) has gained increasing attention among clinicians due to its potential to reduce postoperative diarrhea. Despite this advantage, SC-CRA is also associated with concerns regarding an increased risk of recurrent constipation. The debate surrounding which approach is superior persists. This study aims to resolve this controversy through a comparative analysis of TC-IRA and SC-CRA, evaluating their therapeutic efficacy and safety profiles in refractory STC.

methodsThe STOPS trial is a prospective, randomized, multicenter-controlled clinical trial to compare the effectiveness of TC-IRA versus SC-CRA in treating patients with STC. After screening for eligibility and obtaining informed consent, a total of 252 adult patients will be randomized into two groups in a 1:1 ratio after assuring that none of the exclusion criteria is present. The primary outcome is the Wexner Constipation Score. The secondary outcomes include operative time, conversion rates, blood loss, short- and long-term complications, bowel movements, abdominal pain, bloating, straining, enema use, laxative use, Wexner Incontinence Score, gastrointestinal quality of life index (GIQLI), 36-item Short Form Health Survey (SF-36), and satisfaction. Outcomes will be assessed at baseline and at 1, 3, 6, 12, 24, and 36 months postoperatively. DISCUSSION: This trial will be the first and largest randomized clinical trial to assess whether TC-IRA or SC-CRA should be the standardized surgical treatment for STC in terms of WCS outcomes. We hope that its findings will not only demonstrate the value of the surgical procedure in the treatment of STC, but also provide more reliable clinical evidence for further standardization of STC surgical treatment.

trial registrationSTOPS Trial: A Multicentre Prospective Randomised Clinical Trial Comparing Total Colectomy with Ileorectal Anastomosis Versus Subtotal Colectomy with Cecal-rectal Anastomosis for Slow Transit Constipation ( http://clinicaltrials.gov/ct2/show/NCT05352074 ). Registry identifier: NCT05352074. Registration date: April 3, 2022.