Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.

Phase 3RecruitingNCT07537998

Pei-Rong Ding160 enrolled

Overview

The goal of this clinical trial is to learn if antegrade intestinal fluid reinfusion works to prevent low anterior resection syndrome (LARS) in patients with prophylactic ileal stoma. The main questions it aims to answer are: 1. Does it work to prevent LARS by antegrade intestinal fluid reinfusion before performing the ileostomy reversal surgery? 2. Is antegrade intestinal fluid reinfusion more effective than water infusion in preventing LARS. Participants will: 1. Receive either antegrade intestinal fluid reinfusion or antegrade water infusion through ileal stoma based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal. 2. Keep a diary of their symptoms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Low Anterior Resection Syndrome Rectal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with mid to low rectal cancer (within 10cm of the anal verge) who undergo radical DIXON+ileostomy surgery. * General situation is well and one can take care of themselves. * Anal digital examination confirms that the anastomotic site has fully healed 1 month after surgery. * The anal sphincter function is good, and the ilestomy reverse surgery has not been completed. * Regardless of whether preoperative radiotherapy or chemotherapy has been received. Exclusion Criteria: * Patients with anastomotic leakage after rectal cancer surgery. * The patient's general physical condition is poor and they are unable to take care of themselves. * Expected inability to retract the stoma. * Patients with preoperative inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, etc. * inability to treat according to the plan, poor compliance.

Outcomes

Primary Outcomes

LARS score(m1)

Improvement in LARS score 1 month after ileostomy reversal surgery between the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score).

Time frame: 1 month after ileostomy reversal surgery

Secondary Outcomes

Major LARS rate(m1)

Major LARS rate 1 month after ileostomy reversal

Time frame: 1 month after ileostomy reversal

LARS score (m0-12)

Trajectory of change of LARS score after ileostomy reversal surgery in the two group. Low Anterior Resection Syndrome Score (LARS Score) is a validated specific score for low anterior resection syndrome which ranges from 0 points (normal - best score) to 42 point (LARS major - worst score).

Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

MSKCC BFI

Memorial Sloan Kettering Cancer Centre Bowel Function Instrument

Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

Wexner score

The Wexner scoring system is a clinical tool used to assess the severity of constipation. Mainly used to quantify the constipation symptoms of patients and their impact on their quality of life. Including five aspects: defecation frequency, difficulty in defecation, emptying sensation, abdominal pain, and time spent in the toilet. The total score range is 0-25 points. A score below 7 points is considered mild constipation, 7-15 points is moderate constipation, and above 15 points is severe constipation.

Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

quality of life for rectal cancer patients

quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 )

Time frame: 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months after ileostomy reversal surgery

Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts