NCT05905393

The Protective Role of GABA Stimulation Before Ileostomy Closure

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ileostomy; Complications

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-06-15
• Last updated: 2023-06-15