STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Slow Transit Constipation, Surgery

Intervention / Treatment
-----------------
* Procedure: subtotal colectomy with cecal-rectal anastomosis
* Procedure: total colectomy with ileorectal anastomosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The clinical manifestations all met the Roman IV standard for the diagnosis of functional constipation. Patients with severe constipation symptoms were unable to defecate naturally and need laxatives to assist defecation or still unable to defecate. Colonic transport tests showed that the opaque X-ray markers remained more than 20% after 72 hours. All conservative treatment for more than 1 year failed. Patients had a strong desire for surgery, and no other contraindications to surgery. Exclusion Criteria: Megacolon was detected with barium enema examination. Colonoscopy suggested the presence of intestinal organic lesions or a history of colorectal cancer treatment. Gastric and small intestinal transport dysfunction. rectal inertia. Moderate or severe than depression, anxiety and other mental symptoms. Constipation-predominant irritable bowel syndrome. History of inflammatory bowel disease. enterostomy, without anastomosis. Pregnant Or Lactating Women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: total colectomy with ileorectal anastomosis<br>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<br>* 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.<br>|
| Experimental: subtotal colectomy with cecal-rectal anastomosis<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Slow Transit Constipation, Total Colectomy With Ileorectal Anastomosis, Subtotal Colectomy With Caecorectal Anastomosis, Defecation Function, Quality of Life