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OpenTrials
Completed

NCT Number: NCT03721575

Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty

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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scarpa's preserving hernio-abdominoplasty

Procedure

Scarpa's fascia is preserved during hernio-abdominoplasty

Classical hernio-abdominoplasty

Procedure

Scarpa's fascia is removed during hernio-abdominoplasty

Primary outcomes

  1. Volume of postoperative drainage

    Time frame: Two weeks after surgery

    The volume of fluid drained through suction drains per 24 hours

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2018
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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