The Protective Role of GABA Stimulation Before Ileostomy Closure

Study Overview
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Brief Summary
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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.

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

Conditions
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Ileostomy; Complications

Intervention / Treatment
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* Dietary Supplement: preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery
* Dietary Supplement: preoperative stimulation of the efferent loop with only physiological saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention 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<br>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<br>* 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.<br>|
| Sham Comparator: control group was stimulated without giving any substance<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of complications after ileostomy closure | 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 | Insulin, C peptide | From date of randomization until the date of discharge, assessed up to 20 days | 
| microbiota alteration | microbiota alteration before and after GABA stimulation | From date of randomization until the date of discharge, assessed up to 20 days | 
| metabolite alteration | metabolite alteration before and after GABA stimulation | From date of randomization until the date of discharge, assessed up to 20 days |