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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05352074
Other study ID # 20211114
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2022
Est. completion date December 31, 2026

Study information

Verified date November 2023
Source Third Military Medical University
Contact Yue Tian, MD
Phone 18523159554
Email ty11860602@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 202
Est. completion date December 31, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China The General Hospital of Western Theater Command Chengdu Sichuan
China the First Affiliated Hospital of Harbin Medical University Ha'erbin Heilongjiang
China Zhejiang Provincial People's Hospital Hangzhou Zhejiang
China No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army Lanzhou Gansu
China the People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi
China Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine Pudong Shanghai
China Shanghai Pudong New Area People's Hospital Pudong Shanghai
China Renmin Hospital of Wuhan University Wuhan Hubei
China Zhongnan Hospital of Wuhan University Wuhan Hubei
China Xi-Jing Hospital Xi'an Shanxi
China Army Medical Center Yuzhong Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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 — View Citation

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. — View Citation

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 — View Citation

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 v — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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