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Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty

M

Mansoura University

Status

Completed

Conditions

Ventral Hernia

Treatments

Procedure: Scarpa's preserving hernio-abdominoplasty
Procedure: Classical hernio-abdominoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03721575
mansoura61

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

Scarpa's preserving hernio-abdominoplasty
Active Comparator group
Description:
Hernio-abdominoplasty is performed with preservation of Scarpa's fascia.
Treatment:
Procedure: Scarpa's preserving hernio-abdominoplasty
Classical hernio-abdominoplasty
Active Comparator group
Description:
Hernio-abdominoplasty is performed with removalof Scarpa's fascia.
Treatment:
Procedure: Classical hernio-abdominoplasty

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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