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
About this trial
This is an interventional treatment trial for Ventral Hernia
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.
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
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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