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

Primary Purpose

Post Operative Adhesions

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hyaluronic Acid
NORMAL SALINE
Sponsored by
Services Institute of Medical Sciences, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Adhesions

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    HiB

    Normal saline

    Arm Description

    This group will receive the compound for the reduction of adhesions

    This group will just receive normal saline to ensure blinding.

    Outcomes

    Primary Outcome Measures

    POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL

    Secondary Outcome Measures

    Full Information

    First Posted
    May 23, 2016
    Last Updated
    May 29, 2016
    Sponsor
    Services Institute of Medical Sciences, Pakistan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02790177
    Brief Title
    Role of Hyaluronic Acid in the Prevention of Post-operative Adhesions: a RCT
    Acronym
    HiB
    Official Title
    Is Hyaluronic Acid Effective in the Prevention of Post-operative Adhesion?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Services Institute of Medical Sciences, Pakistan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Adhesions

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HiB
    Arm Type
    Experimental
    Arm Description
    This group will receive the compound for the reduction of adhesions
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    This group will just receive normal saline to ensure blinding.
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic Acid
    Intervention Type
    Drug
    Intervention Name(s)
    NORMAL SALINE
    Primary Outcome Measure Information:
    Title
    POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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