Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty

Scarpa Fascia Preservation Versus Removal During Hernio-abdominoplasty: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: Scarpa's preserving hernio-abdominoplasty; Procedure: Classical hernio-abdominoplasty

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scarpa's preserving hernio-abdominoplasty; Hernio-abdominoplasty is performed with preservation of Scarpa's fascia.	Procedure: Scarpa's preserving hernio-abdominoplasty; Scarpa's fascia is preserved during hernio-abdominoplasty
Active Comparator: Classical hernio-abdominoplasty; Hernio-abdominoplasty is performed with removalof Scarpa's fascia.	Procedure: Classical hernio-abdominoplasty; Scarpa's fascia is removed during hernio-abdominoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of postoperative drainage	The volume of fluid drained through suction drains per 24 hours	Two weeks after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Sameh H Emile, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: mansoura61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No