Surgery Clinical Trial
Official title:
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Third Military Medical University |
China,
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
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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