NCT05352074

STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

STOPS Trial: A Multicentre Prospective Randomised Clinical Trial Comparing Total Colectomy With Ileorectal Anastomosis Versus Subtotal Colectomy With Cecal-rectal Anastomosis for Slow Transit Constipation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial.

Detailed description

Constipation, a prevalent gastrointestinal disorder, affects 10%-15% of adults in the United States and approximately 8.2% of China's general population. Slow transit constipation (STC), accounting for 15%-42% of constipation cases, is characterized by impaired colonic motility. For patients refractory to conservative therapies who experience chronic, intractable symptoms and diminished quality of life (QoL), surgical intervention becomes the last-resort treatment. The primary surgical approach for STC has historically been total colectomy with ileorectal anastomosis (TC-IRA). Over the past two decades, however, subtotal colectomy with cecorectal anastomosis (SC-CRA) has garnered growing interest within the surgical community due to its potential to mitigate postoperative diarrhea. Despite this benefit, SC-CRA raises concerns about an elevated risk of recurrent constipation. The debate regarding the superiority of these approaches remains unresolved. This study aims to address this controversy through a comparative analysis of TC-IRA and SC-CRA, evaluating their therapeutic efficacy and safety profiles in refractory STC.

Conditions

• Slow Transit Constipation
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Total colectomy with ileorectal anastomosis	Following complete colonic mobilization without preservation of the ileocolic vascular pedicle, the surgical specimen was extracted by extending the right lower quadrant trocar incision to approximately 4-5 cm. A resection of ileum, 2-3 cm proximal to the ileocecal junction, will be conducted by stapler. The anvil of a 29-mm circular stapler was inserted into the proximal ileal lumen and repositioned intra-abdominally. Ileorectal anastomosis was performed by transanal insertion of the circular stapler, aiming to achieve a tension-free, contamination-minimized reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in layers.
PROCEDURE	Subtotal colectomy with cecal-rectal anastomosis	Following complete colonic mobilization with preservation of the ileocolic vascular pedicle and its branches, the surgical specimen was extracted by extending the right lower quadrant trocar incision to 4-5 cm. After insertion of the anvil from a 29-mm circular stapler through the ascending colon resection margin, a resection about 3 cm distal to the ileocecal junction will be conducted. The cecum was then positioned in the pelvis without rotational torsion, and an antiperistaltic cecorectal anastomosis was created between cecal fundus (after appendectomy) and the rectal stump. The anastomosis was performed via transanal insertion of the circular stapler to ensure tension-free, contamination-controlled reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in a layered fashion.

Timeline

• Start date: 2022-03-27
• Primary completion: 2025-05-01
• Completion: 2028-05-01
• First posted: 2022-04-28
• Last updated: 2026-04-14

Locations

14 sites across 1 country: China