Gastric Ultrasonography to assess the effect of Probiotics on Gastric residual volume in Diabetic patients planned for Cancer resection surgery: A Randomised Controlled Trial
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
Dr Sambit Nandi
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
