STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

NCT05352074 | Active Not Recruiting DMC

• 1 other identifier: 20211114
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Surgery; Slow Transit Constipation

Keywords

Slow Transit Constipation; Total Colectomy with Ileorectal Anastomosis; Subtotal Colectomy with Caecorectal Anastomosis; Defecation Function; Quality of Life; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Wexner Constipation Score

  The Wexner Constipation Score will be recorded in terms of scores. Questions examine constipation in its clinical expressions. Each question is answered on a scale of 0 to 4. The scale ranges from 0 (best) to 30 (worst)

  From the pre-operation to 36 months following surgery

Secondary Outcomes (12)

• Gastrointestinal Quality of Life Index

  From the pre-operation to 36 months following surgery

• 36-item short-form health survey

  From the pre-operation to 36 months following surgery

• The incidence of complications

  From the pre-operation to 36 months following surgery

• The number of bowel movements per week

  From the pre-operation to 36 months following surgery

• Wexner's incontinence score

  From the pre-operation to 36 months following surgery

Study Arms (2)

Total colectomy with ileorectal anastomosis

ACTIVE COMPARATOR

Total colectomy with ileorectal anastomosis (TC-IRA) serves as the standard surgical treatment for slow transit constipation.

Procedure: Total colectomy with ileorectal anastomosis

Subtotal colectomy with cecal-rectal anastomosis

EXPERIMENTAL

Subtotal colectomy with cecorectal anastomosis (SC-CRA) is selectively employed for slow transit constipation.

Procedure: Subtotal colectomy with cecal-rectal anastomosis

Interventions

Total colectomy with ileorectal anastomosis PROCEDURE

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.

Total colectomy with ileorectal anastomosis

Subtotal colectomy with cecal-rectal anastomosis PROCEDURE

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.

Subtotal colectomy with cecal-rectal anastomosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (≥18 years of age) of either sex
• Patients with conditions in agreement with the Roman IV criteria of functional constipation
• Patients have less than one complete spontaneous bowel movement per week
• Patients rely on laxatives to assist defecation for a long time
• More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
• Patients were refractory to conservative treatment for more than 1 year
• Patients with a strong desire for surgery

You may not qualify if:

• Pregnant or breast-feeding women
• Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
• Patients with colorectal neoplasms
• Patients with small intestinal slow transit
• Patients with constipation-predominant irritable bowel syndrome
• Patients with inflammatory bowel disease
• Patients with ileostomy
• Patients with severe psychiatric disease

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (14)

Army Medical Center (Daping Hospital)

Yuzhong, Chongqing Municipality, 400042, China

Location

No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army

Lanzhou, Gansu, 730050, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

Location

General Hospital of the Eastern Theater Cammand of the PLA

Nanjing, Jiangsu, 210002, China

Location

The First Hospital of China Medical University

Shengyang, Liaoning, 110001, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China

Location

Renji Hospital, Shanghai Jiaotong University

Pudong, Shanghai Municipality, 200127, China

Location

Shanghai Pudong New Area People's Hospital

Pudong, Shanghai Municipality, 201299, China

Location

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

Chengdu Analrectal Hospital

Chengdu, Sichuan, 610017, China

Location

The General Hospital of Western Theater Command

Chengdu, Sichuan, 610036, China

Location

The Second People's Hospital of Yibin

Yibin, Sichuan, 644000, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

Related Publications (6)

• Macha MR. The feasibility of laparoscopic subtotal colectomy with cecorectal anastomosis in community practice for slow transit constipation. Am J Surg. 2019 May;217(5):974-978. doi: 10.1016/j.amjsurg.2019.03.018. Epub 2019 Mar 26.

  PMID: 30948148 RESULT

• Wei D, Cai J, Yang Y, Zhao T, Zhang H, Zhang C, Zhang Y, Zhang J, Cai F. A prospective comparison of short term results and functional recovery after laparoscopic subtotal colectomy and antiperistaltic cecorectal anastomosis with short colonic reservoir vs. long colonic reservoir. BMC Gastroenterol. 2015 Mar 18;15:30. doi: 10.1186/s12876-015-0257-7.

  PMID: 25887580 RESULT

• Perivoliotis K, Baloyiannis I, Tzovaras G. Cecorectal (CRA) versus ileorectal (IRA) anastomosis after colectomy for slow transit constipation (STC): a meta-analysis. Int J Colorectal Dis. 2022 Mar;37(3):531-539. doi: 10.1007/s00384-022-04093-y. Epub 2022 Jan 12.

  PMID: 35020001 RESULT

• Knowles CH, Grossi U, Horrocks EJ, Pares D, Vollebregt PF, Chapman M, Brown S, Mercer-Jones M, Williams AB, Yiannakou Y, Hooper RJ, Stevens N, Mason J; NIHR CapaCiTY working group; Pelvic floor Society and; European Society of Coloproctology. Surgery for constipation: systematic review and practice recommendations: Graded practice and future research recommendations. Colorectal Dis. 2017 Sep;19 Suppl 3:101-113. doi: 10.1111/codi.13775.

  PMID: 28960922 RESULT

• Deng XM, Zhu TY, Wang GJ, Gao BL, Li RX, Wang JT. Laparoscopic total colectomy with ileorectal anastomosis and subtotal colectomy with antiperistaltic cecorectal anastomosis for slow transit constipation. Updates Surg. 2023 Jun;75(4):871-880. doi: 10.1007/s13304-023-01458-y. Epub 2023 Mar 14.

  PMID: 36914915 RESULT

• Tian Y, Guo M, Bu F, Ni L, Liu W, Gao F, Lan H, Cui Z, Fu T, Wang Y, Li F, Xu D, Gao H, Zhang L, Liu X, Huang B, Wang L, Jiang C, Jiang J, Gong W, Tong W. 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). Trials. 2025 Oct 10;26(1):402. doi: 10.1186/s13063-025-09049-5.

  PMID: 41074220 DERIVED

Study Officials

• Weidong Tong, MD

  Army Medical Center (Daping Hospital)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: April 28, 2022
• Study Start: March 27, 2022
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)