Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721575
• Other study ID #: mansoura61
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• Scarpa's preserving hernio-abdominoplasty
Scarpa's fascia is preserved during hernio-abdominoplasty
• Classical hernio-abdominoplasty
Scarpa's fascia is removed during hernio-abdominoplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of postoperative drainage	The volume of fluid drained through suction drains per 24 hours	Two weeks after surgery