The Protective Role of GABA Stimulation Before Ileostomy Closure

June 7, 2023 updated by: Wei Guo, Qilu Hospital of Shandong University

The Protective Role of Preoperative Stimulation of the Distal Limb of the Ileostomy Loop With GABA Before Ileostomy Closure

The goal of this clinical trial is to explore whether preoperative stimulation of the distal limb of the ileostomy loop with gamma aminobutyric acid (GABA) could effectively reduce the incidence of complications after ileostomy closure.

Participants will be divided into two groups. One group included patients treated with stimulation of the efferent loop with GABA prior to transit reconstruction surgery; the other control group was stimulated without giving any substance.

Researchers will compare incidence of complications such as postoperative ileus, diarrhea and other parameters such as time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay, etc.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • over 18 years of age;
  • body mass index (BMI) 18.5-28 kg/m2;
  • having protective ileostomy after colorectal carcinoma surgery free of disease;
  • with endoscopic and histological confirmation of diversion colitis;
  • no oral antibiotics within 3 months;
  • having signed the informed consent.

Exclusion Criteria:

  • under 18 years of age;
  • clinical history, and histological confirmation of inflammatory bowel disease with colorectal involvement;
  • history of neoadjuvant or adjuvant chemoradiotherapy;
  • other serious chronic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, etc;
  • serious perioperative complications such as anastomotic rupture after surgery;
  • oral antibiotics within three months;
  • participation in any other studies within the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery
Preoperative stimulation of the distal limb of the ileostomy loop with GABA was performed during the 5 days prior to surgery every day. During the process and after it, the patient himself registers the appearance of symptoms after each stimulation session: abdominal pain, emission of gas and stool. Sterile Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline. Each preparation was made under sterile conditions and maintaining the cold chain.
Dietary supplement: preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery
Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline.
Sham Comparator: control group was stimulated without giving any substance

Control group was stimulated without giving any substance. During the process and after it, the patient himself registers the appearance of symptoms after each stimulation session: abdominal pain, emission of gas and stool.

After 5 stimulation sessions, reconstructive surgery was performed within the following 24 h.
Dietary supplement: preoperative stimulation of the efferent loop with only physiological saline
Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of 100 ml of 0.9% physiological saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of complications after ileostomy closure
Time Frame: From date of randomization until the date of discharge, assessed up to 20 days
postoperative ileus, diarrhea, time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay.
From date of randomization until the date of discharge, assessed up to 20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose metabolism-related parameters
Time Frame: From date of randomization until the date of discharge, assessed up to 20 days
Insulin, C peptide
From date of randomization until the date of discharge, assessed up to 20 days
microbiota alteration
Time Frame: From date of randomization until the date of discharge, assessed up to 20 days
microbiota alteration before and after GABA stimulation
From date of randomization until the date of discharge, assessed up to 20 days
metabolite alteration
Time Frame: From date of randomization until the date of discharge, assessed up to 20 days
metabolite alteration before and after GABA stimulation
From date of randomization until the date of discharge, assessed up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • KYLL-202212-066-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe