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

NCT ID: NCT02790177

Last Updated: 2016-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Post Operative Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HiB

This group will receive the compound for the reduction of adhesions

Group Type EXPERIMENTAL

Hyaluronic Acid

Intervention Type DRUG

Normal saline

This group will just receive normal saline to ensure blinding.

Group Type PLACEBO_COMPARATOR

NORMAL SALINE

Intervention Type DRUG

Interventions

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Hyaluronic Acid

Intervention Type DRUG

NORMAL SALINE

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Usman Ismat Butt

Senior Registrar

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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ServicesIMSP

Identifier Type: -

Identifier Source: org_study_id

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