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

May 29, 2016 updated by: Usman Ismat Butt, Services Institute of Medical Sciences, Pakistan

Is Hyaluronic Acid Effective in the Prevention of Post-operative Adhesion?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HiB
This group will receive the compound for the reduction of adhesions
Drug: Hyaluronic Acid
PLACEBO_COMPARATOR: Normal saline
This group will just receive normal saline to ensure blinding.
Drug: NORMAL SALINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 29, 2016

First Posted (ESTIMATE)

June 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 29, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ServicesIMSP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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