STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

STOPS Trial: A Multicentre 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. Subtotal colectomy with caecorectal anastomosis is suggested to be a superior approach. However, the optimal surgical option for slow transit constipation (STC) is controversial.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Slow Transit Constipation
• Intervention / Treatment: Procedure: total colectomy with ileorectal anastomosis; Procedure: subtotal colectomy with cecal-rectal anastomosis

Detailed Description

Constipation is an ever-growing problem and one of the most common gastrointestinal symptoms, affecting 10-15% of adults in the USA and 8.2% of the general population in China. Slow transit constipation(STC), representing 15~30% constipated patients, is characterized by a loss in the colonic motor activity. Factors such as increasing age, female sex, physical inactivity, endocrine,metabolism, neurological factors, drug use, and depression are associated with constipation. While most patients with constipation are mild and treated easily by a behavioral and medical way, a minority of patients suffering from long-term intractable symptoms and poor quality of life and showing no response to any medical interventions are ultimately recommended for surgery.Since the effectiveness of colectomy for constipation was first reported by Lane a century ago, surgical treatment for constipation has been greatly developed, including ileorectal anastomosis (IRA), cecorectal anastomosis(CRA), colonic exclusion, antegrade enemas (the Maloneprocedure), modified Duhamel surgery, and permanent ileostomy. Currently,the main surgical procedures for STC are total colectomy with ileorectal anastomosis (TC-IRA) and subtotal colectomy with caecorectal anastomosis(SC-CRA), which have been widely confirmed to increase bowel-movement frequency in a huge number of patients. However, TC-IRA is a traditional surgical option for slow transit constipation. SC-CRA is suggested to be a superior approach. However, the optimal surgical option for slow transit constipation (STC) is controversial.This study aims to compare TC-IRA versus SC-CRA for STC with respect to the short- and long-term defecation function and overall quality of life during 3-year regular follow-up.

• Study Type: Interventional
• Enrollment (Anticipated): 202
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weidong Tong, MD; Phone Number: 02368757955 02368757955; Email: vdtong@163.com
• Study Contact Backup: Name: Yue Tian, MD; Phone Number: +8602368729357 18523159554; Email: ty11860602@163.com

Study Locations

• China
  • Chongqing
    • Yuzhong, Chongqing, China, 400042
      • Recruiting
      • Army Medical Center
      • Contact: Weidong Tong, MD; Phone Number: 86-23-68757956; Email: vdtong@163.com
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Recruiting
      • No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army
      • Contact: Feng Gao, doctor
  • Guangxi
    • Nanning, Guangxi, China, 530016
      • Recruiting
      • The people's hospital of Guangxi Zhuang Autonomous Region
      • Contact: Liming Pang, doctor
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China, 150007
      • Recruiting
      • The First Affiliated Hospital Of Harbin Medical University
      • Contact: Anlong Zhu, doctor
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Tao Fu, dorctor
    • Wuhan, Hubei, China, 430062
      • Recruiting
      • Zhongnan hospital of Wuhan University
      • Contact: Congqing Jiang, doctor
  • Shanghai
    • Pudong, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Contact: Ji Cui, doctor
    • Pudong, Shanghai, China, 201299
      • Recruiting
      • Shanghai Pudong New Area People's Hospital
      • Contact: Yongbing Wang, doctor
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Xi-Jing Hospital
      • Contact: Jianyong Zheng
  • Sichuan
    • Chengdu, Sichuan, China, 610036
      • Recruiting
      • The General Hospital of Western Theater Command
      • Contact: Lin Zhang, doctor
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Wenjing Gong, doctor

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. The clinical manifestations all met the Roman IV standard for the diagnosis of functional constipation.
2. Patients with severe constipation symptoms were unable to defecate naturally and need laxatives to assist defecation or still unable to defecate.
3. Colonic transport tests showed that the opaque X-ray markers remained more than 20% after 72 hours.
4. All conservative treatment for more than 1 year failed.
5. Patients had a strong desire for surgery, and no other contraindications to surgery.

Exclusion Criteria:

1. Megacolon was detected with barium enema examination.
2. Colonoscopy suggested the presence of intestinal organic lesions or a history of colorectal cancer treatment.
3. Gastric and small intestinal transport dysfunction.
4. rectal inertia.
5. Moderate or severe than depression, anxiety and other mental symptoms.
6. Constipation-predominant irritable bowel syndrome.
7. History of inflammatory bowel disease.
8. enterostomy, without anastomosis.
9. Pregnant Or Lactating Women.

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; After a complete mobilization of the colon, a resection 2-3 cm proximal to the ileocecal junction is conducted. Use a Pfannestiel incision to perform the anastomosis and to remove the resected colon. The ileorectal anastomosis is performed by introducing the stapler via the anus, with the intention of carrying out a ''cleaner,'' ''tensionless'' procedure.	Procedure: total colectomy with ileorectal anastomosis; After a complete mobilization of the colon, a resection 2-3 cm proximal to the ileocecal junction is conducted. Use a Pfannestiel incision to perform the anastomosis and to remove the resected colon. The ileorectal anastomosis (end to end) is performed by introducing the stapler via the anus, with the intention of carrying out a ''cleaner,'' ''tensionless'' procedure.
Experimental: subtotal colectomy with cecal-rectal anastomosis; After a complete mobilization of the colon, a resection 2-3cm distal to the ileocecal junction and at the upper part of the rectal ampulla are conducted; the cecum is then lowered into the pelvis, without any rotation, and an antiperistaltic cecorectal anastomosis is performed between the cecal fundus (after appendectomy) and the rectum, after introduction of a stapler through the cecal resection line. Use a Pfannestiel incision to perform the anastomosis and to remove the resected colon. The cecal-rectal anastomosis is performed by introducing the stapler via the anus, with the intention of carrying out a ''cleaner,'' ''tensionless'' procedure.	Procedure: subtotal colectomy with cecal-rectal anastomosis; The intervention involves, after a complete mobilization of the colon, a resection 2-3 cm distal to the ileocecal junction and at the upper part of the rectal ampulla; the cecum is then lowered into the pelvis, without any rotation, and an antiperistaltic cecorectal anastomosis is performed between the cecal fundus (after appendectomy) and the rectum, after introduction of a stapler through the cecal resection line. In the laparoscopic approach we use 5 trocars (trocar 1 periumbilical, trocars 2-3-4-5 drawing a 15-cm side square around trocar 1), using a Pfannestiel incision to perform the anastomosis and to remove the resected colon. The cecal-rectal anastomosis is performed by introducing the stapler via the anus, with the intention of carrying out a ''cleaner,'' ''tensionless'' procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The scales of Wexner Constipation	the scales of Wexner Constipation 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 the three years following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The scales of Gastrointestinal Quality of Life Index	the scales of Gastrointestinal Quality of Life Index will be recorded in terms of scores. There are 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 the three years following surgery
The results of the short-form(SF)-36 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 the three years 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 the three years 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 the three years following surgery
The scales of Wexner Incontinence	the scales of Wexner Incontinence 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 the three years 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 the three years following surgery
the incidence of bloating	the incidence of bloating will be recorded in terms of percent	from the pre-operation to the three years following surgery
the incidence of diarrhea	the incidence of diarrhea will be recorded in terms of percent.	from the pre-operation to the three years following surgery
the incidence of straining	the incidence of straining will be recorded in terms of percent.	from the pre-operation to the three years following surgery
the incidence of laxative use	the incidence of laxative use will be recorded in terms of percent.	from the pre-operation to the three years 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 the three years following surgery

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Study Chair: Weidong Tong Tong, MD, Army Medical Center

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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2026

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): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Slow Transit Constipation; Total Colectomy With Ileorectal Anastomosis; Subtotal Colectomy With Caecorectal Anastomosis; Defecation Function
• 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