Postoperative Bowel Function After SPS by Different Reconstruction Methods

NCT03669237 | Completed

• 1 other identifier: Bas-1904
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is one of the most common malignant tumors in the world. Surgery is still the main treatment for rectal cancer. With the popularization of stapler technology and the application of preoperative neoadjuvant therapy, more and more patients with rectal cancer have treated sphincter preservation surgery for rectal cancer. postoperative observation found that some patients with rectal cancer anus-preserving surgery had different degrees of defecation dysfunction after surgery, such as incontinence, tightness, increased frequency of bowel movements, and constipation. These clinical symptoms have been classified as "Low anterior resection syndrome (LARS)" in recent years.Now there is no treatment for LARS.Meanwhile,J-pouch and side-to-end anastomosis can help the patients,but there is few trials can prove this.This trial means to prove weather side-to-end anastomosis can improve bowel of rectal patients afer surgery.

Conditions

Bowel; Functional Syndrome

Keywords

Bowel Function; Sphincter Preservation Surgery; Reconstruction Method

Outcome Measures

Primary Outcomes (1)

• Postoperative bowel function of 1 year after surgery

  Each patients will be interviewed by telephone and asked to answer a copy of LARS score questionnaire. Designed for LARS patients only, the LARS score is a total score questionnaire containing five single choice questions with a corresponding score for each option. Each of the five questions tested a single symptom of the bowel function, including incontinence for flatus(score value from 0 to 7), incontinence for liquid stool (score value from 0 to 3), frequency of bowel movement (score value from 0 to 5), clustering of stools (score value from 0 to 11) and urgency (score value from 0 to 16). According to the total score of each patient, the questionnaire can evaluate the defecation function of the subject, which is divided into three categories from best to worst: no LARS (0 to 20), miner LARS (21 to 29) and major LARS (30 to 42).

  1 year after surgery

Secondary Outcomes (3)

• Operation safety

  Data will be assess during operation and at the last visit before check-off.

• Postoperative bowel function within the first year

  from the first month to the 11th month

• Postoperative bowel function of the long stable result

  16 months after the primary surgery

Study Arms (2)

end-to-side anastomosis

EXPERIMENTAL

All surgeries during the study were performed by the same experienced surgical team and were performed following TME principles. End-to-side anastomosis was used to perform colorectal anastomosis after primary tumor resection.

Procedure: different reconstruction methods

end-to-end anastomosis

NO INTERVENTION

All surgeries during the study were performed by the same experienced surgical team and were performed following TME principles. After resection of the primary tumor, end-to-end anastomosis was used for colorectal anastomosis.

Interventions

different reconstruction methods PROCEDURE

Different reconstruction methods should be performed after sphincter preservation surgery in two groups.The methods include end-to-end anastomosis or end-to-side anastomosis

end-to-side anastomosis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The rectal adenocarcinoma is proved by pathology before surgery
• The lower margin of the tumor is less than 12cm higher from the anal verge under no anesthesia measured
• The tumor can be excised discussed by MDT
• Anus preserving operation can be performed
• ECOG score ranges between 0 and 2
• The estimate life is supposed to be more than 12 months
• The informed consent should be signed

You may not qualify if:

• The patient can not follow the experimental scheme
• The case is an emergency
• The patient is in pregnant or breast-feeding
• TME surgery can not be performed
• One-stage anastomosis can not be performed
• The patient has a history of anus surgery or rectal surgery
• The patient has a history of left hemicolectomy
• The patient has a long history of bowel dysfunction，such as diarrhea or dysporia before surgery
• The patient has cognitive disorder or communication disorder
• The patient has repeat infection or other disorders poorly controlled
• The patient joins other clinical trail that may disturb the bowel function

Sponsors & Collaborators

• YE Yingjiang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yingjiang Ye, M.D. ＆ PhD.

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of GI surgery department

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: October 12, 2018
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

CN (1)