Skip to main content
Clinical Trials/CTRI/2026/03/0106336
CTRI/2026/03/0106336RecruitingNot Applicable

Gastric Ultrasonography to assess the effect of Probiotics on Gastric residual volume in Diabetic patients planned for Cancer resection surgery: A Randomised Controlled Trial

All India Institute of Medical Sciences1 site in 1 country146 target enrollmentStarted: March 27, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
146
Locations
1
Primary Endpoint
To assess the effect of probiotics on gastric residual volume evaluated ultrasonographically in diabetics undergoing cancer resection surgery

Study Overview

Brief Summary

Diabetic patients are prone to have gastroparesis with increased gastric content. A full stomach is a well-known risk factor for aspiration in the perioperative period and the development of postoperative pulmonary complications.Little is known about the pathophysiology of gastroparesis in diabetics. Duodenal micro-inflammation due to dysbiosis is one of the pathological signatures of gut-brain axis alterations thought to be responsible for gastroparesis. Probiotics helps in maintaining gut microbiota and thus in preventing gastroparesis. Gastric ultrasound (USG) is non-invasive, easy to perform at the bedside with minimal discomfort,and avoids radiation exposure. It also provides reliable quantitative and qualitative information about the nature of gastric contents before anesthesia. Thus, it is a useful tool for assessing the risk of pulmonary aspiration, which has greatly altered clinical management during anesthesia. Gastric volume measured by USG is a good parameter to establish gastric emptying. Thus we hypothesize that preoperative ingestion of probiotics will decrease residual gastric volume.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • diabetic patients
  • age between 18 to 70 years
  • HBa1C level less than 8
  • undergoing Non-GI surgery.

Exclusion Criteria

  • Refusal to participate 2.Previous history of gastric surgery
  • Any other condition associated with delayed gastric emptying
  • Unable to take orally.

Outcomes

Primary Outcomes

To assess the effect of probiotics on gastric residual volume evaluated ultrasonographically in diabetics undergoing cancer resection surgery

Time Frame: Probiotics drink started 7 days prior to surgery and continued till the night before surgery. Gastric residual volume estimated on the day of surgery

Secondary Outcomes

  • 1) To measure the difference in Perlas grading between both groups(2) To determine the ease of obtaining USG parameters)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Sambit Nandi

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

Study Sites (1)

Loading locations...

Similar Trials