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Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty

Primary Purpose

Ventral Hernia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scarpa's preserving hernio-abdominoplasty
Classical hernio-abdominoplasty
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with complex ventral hernia that are fit for surgery (ASA class I and II) (Saklad, 1941).
  • Patients with class III, IV according to Pitanguy's classification of abdominal deformities (Pitanguy, 1995).

Exclusion Criteria:

  1. Patient with ASA class III, IV, and V.
  2. Morbid obesity (BMI > 40).
  3. Recurrent incisional hernias after mesh hernioplasty.
  4. Strangulated hernias.
  5. Isolated small paraumbilical hernias.
  6. Patients with abdominal organomegaly and/or ascites.
  7. Patients with coagulopathy,
  8. Patients who are heavy smokers, patients with pulmonary problems, and patients with uncontrolled diabetes.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Scarpa's preserving hernio-abdominoplasty

    Classical hernio-abdominoplasty

    Arm Description

    Hernio-abdominoplasty is performed with preservation of Scarpa's fascia.

    Hernio-abdominoplasty is performed with removalof Scarpa's fascia.

    Outcomes

    Primary Outcome Measures

    Volume of postoperative drainage
    The volume of fluid drained through suction drains per 24 hours

    Secondary Outcome Measures

    Full Information

    First Posted
    October 25, 2018
    Last Updated
    October 25, 2018
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03721575
    Brief Title
    Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty
    Official Title
    Scarpa Fascia Preservation Versus Removal During Hernio-abdominoplasty: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2018 (Actual)
    Study Completion Date
    October 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomized trial aimed to assess the efficacy of preservation of Scarpa's fascia during hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to drain removal and recovery, and reducing complication rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventral Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Scarpa's preserving hernio-abdominoplasty
    Arm Type
    Active Comparator
    Arm Description
    Hernio-abdominoplasty is performed with preservation of Scarpa's fascia.
    Arm Title
    Classical hernio-abdominoplasty
    Arm Type
    Active Comparator
    Arm Description
    Hernio-abdominoplasty is performed with removalof Scarpa's fascia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scarpa's preserving hernio-abdominoplasty
    Intervention Description
    Scarpa's fascia is preserved during hernio-abdominoplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Classical hernio-abdominoplasty
    Intervention Description
    Scarpa's fascia is removed during hernio-abdominoplasty
    Primary Outcome Measure Information:
    Title
    Volume of postoperative drainage
    Description
    The volume of fluid drained through suction drains per 24 hours
    Time Frame
    Two weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with complex ventral hernia that are fit for surgery (ASA class I and II) (Saklad, 1941). Patients with class III, IV according to Pitanguy's classification of abdominal deformities (Pitanguy, 1995). Exclusion Criteria: Patient with ASA class III, IV, and V. Morbid obesity (BMI > 40). Recurrent incisional hernias after mesh hernioplasty. Strangulated hernias. Isolated small paraumbilical hernias. Patients with abdominal organomegaly and/or ascites. Patients with coagulopathy, Patients who are heavy smokers, patients with pulmonary problems, and patients with uncontrolled diabetes.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sameh H Emile
    Organizational Affiliation
    Mansoura University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty

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