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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery; Slow Transit Constipation
• Intervention / Treatment: Procedure: Total colectomy with ileorectal anastomosis; Procedure: Subtotal colectomy with cecal-rectal anastomosis

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.

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Yuzhong, Chongqing Municipality, China, 400042
      • Army Medical Center (Daping Hospital)
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430062
      • Zhongnan Hospital of Wuhan University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • General Hospital of the Eastern Theater Cammand of the PLA
  • Liaoning
    • Shengyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Shandong
    • Qingdao, Shandong, China, 266011
      • Qingdao Municipal Hospital
  • Shanghai Municipality
    • Pudong, Shanghai Municipality, China, 200127
      • Renji Hospital, Shanghai Jiaotong University
    • Pudong, Shanghai Municipality, China, 201299
      • Shanghai Pudong New Area People's Hospital
  • Shanxi
    • Xi’an, Shanxi, China, 710032
      • Xijing Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610036
      • The General Hospital of Western Theater Command
    • Chengdu, Sichuan, China, 610017
      • Chengdu Analrectal Hospital
    • Yibin, Sichuan, China, 644000
      • The Second People's Hospital of Yibin
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

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

Exclusion criteria

1. Pregnant or breast-feeding women
2. Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
3. Patients with colorectal neoplasms
4. Patients with small intestinal slow transit
5. Patients with constipation-predominant irritable bowel syndrome
6. Patients with inflammatory bowel disease
7. Patients with ileostomy
8. Patients with severe psychiatric disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total colectomy with ileorectal anastomosis; Total colectomy with ileorectal anastomosis (TC-IRA) serves as the standard surgical treatment for slow transit constipation.	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.
Experimental: Subtotal colectomy with cecal-rectal anastomosis; Subtotal colectomy with cecorectal anastomosis (SC-CRA) is selectively employed for slow transit constipation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Quality of Life Index	Gastrointestinal Quality of Life Index will be recorded in terms of scores. There are The four possible answers to every question, scored from 0 points (worst) to 4 points (best). The final sum ranges from 0(worst) to 144(best).	From the pre-operation to 36 months following surgery
36-item short-form health survey	There are eight spheres in the SF-36 survey, including physical function, role physical, role emotional, physical pain, vitality, mental health, social function and general health. Results of each sphere will be recorded in terms of scores. Once the questionnaire was applied to the patients, a summary calculation and a linear transformation were performed to obtain a score within a scale from 0(worst) to 100(best).	From the pre-operation to 36 months following surgery
The incidence of complications	Postoperative complications includes short-term and long-term complications, such as ileus, anastomotic leak, small intestinal obstruction, constipation recurrence and so on. Number of Participants with complications will be recorded.	From the pre-operation to 36 months following surgery
The number of bowel movements per week	The number of bowel movements will be recorded in terms of times per week.	From the pre-operation to 36 months following surgery
Wexner's incontinence score	The Wexner's incontinence score will be recorded in terms of scores. the sacles have 5 items to quantify incontinence grade and frequency and its effect on ordinary life. Each question is answered on a scale of 0 to 4, the global score ranging from 0 (best) to 20 (worst).	From the pre-operation to 36 months following surgery
The incidence of abdominal pain	The incidence of abdominal pain will be recorded in terms of percent. no special measurement is needed.	From the pre-operation to 36 months following surgery
The incidence of bloating	The incidence of bloating will be recorded in terms of percent	From the pre-operation to 36 months following surgery
The incidence of diarrhea	The incidence of diarrhea will be recorded in terms of percent.	From the pre-operation to 36 months following surgery
The incidence of straining	The incidence of straining will be recorded in terms of percent.	From the pre-operation to 36 months following surgery
The incidence of laxative use	The incidence of laxative use will be recorded in terms of percent.	From the pre-operation to 36 months following surgery
The incidence of enema use	The incidence of enema use use will be recorded in terms of percent.	From the pre-operation to 36 months following surgery
Intraoperative measures	Operation time (minutes), blood loss (mL), complications (classified according to Clavien-Dindo) for both study groups.	Perioperative period

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Study Director: Weidong Tong, MD, Army Medical Center (Daping Hospital)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2022
• Primary Completion (Actual): May 1, 2025
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 3, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Randomized Controlled Trial; Slow Transit Constipation; Defecation Function; Total Colectomy with Ileorectal Anastomosis; Subtotal Colectomy with Caecorectal Anastomosis
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 20211114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No