Ileostomy; Complications
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTpreoperative 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_SUPPLEMENTpreoperative 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.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of complications after ileostomy closure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| metabolite alteration | From date of randomization until the date of discharge, assessed up to 20 days | metabolite alteration before and after GABA stimulation |
| glucose metabolism-related parameters | From date of randomization until the date of discharge, assessed up to 20 days | Insulin, C peptide |
| microbiota alteration | From date of randomization until the date of discharge, assessed up to 20 days | microbiota alteration before and after GABA stimulation |
Contacts
Primary ContactWei Guo, Dr.
Backup ContactJiajia Mao, Dr.
Outcome results
None listed