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
|
|
|
PLACEBO_COMPARATOR: Normal saline
This group will just receive normal saline to ensure blinding.
|
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.
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.