Role of Hyaluronic Acid in the Prevention of Post-operative Adhesions: a RCT

Phase 3

• Conditions: Post Operative Adhesions
• Interventions: Drug: NORMAL SALINE; Drug: Hyaluronic Acid

• Registration Number: NCT02790177
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

Brief Summary

The objective of study is to determine the effect of hyaluronic acid on the formation of post-operative adhesions. It will be a randomized control trial comparing the product against normal saline.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-29
• Last Update Submitted: 2016-05-29
• Study Start: 2016-06
• Study First Posted: 2016-06-03
• Last Update Posted: 2016-06-03
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All consenting patients between the ages of 12-80, who undergo exploratory laparotomy and stoma formation

Exclusion Criteria

Previous history of abdominal surgery History of peritoneal dialysis Patients in whom permanent stoma is formed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	NORMAL SALINE	This group will just receive normal saline to ensure blinding.
HiB	Hyaluronic Acid	This group will receive the compound for the reduction of adhesions

Primary Outcome Measures

Name	Time	Method
POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL	3 months