Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty

NCT ID: NCT03721575

Last Updated: 2018-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Scarpa's preserving hernio-abdominoplasty

Hernio-abdominoplasty is performed with preservation of Scarpa's fascia.

Group Type ACTIVE_COMPARATOR

Scarpa's preserving hernio-abdominoplasty

Intervention Type PROCEDURE

Scarpa's fascia is preserved during hernio-abdominoplasty

Classical hernio-abdominoplasty

Hernio-abdominoplasty is performed with removalof Scarpa's fascia.

Group Type ACTIVE_COMPARATOR

Classical hernio-abdominoplasty

Intervention Type PROCEDURE

Scarpa's fascia is removed during hernio-abdominoplasty

Interventions

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Scarpa's preserving hernio-abdominoplasty

Scarpa's fascia is preserved during hernio-abdominoplasty

Intervention Type PROCEDURE

Classical hernio-abdominoplasty

Scarpa's fascia is removed during hernio-abdominoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Other Identifiers

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mansoura61

Identifier Type: -

Identifier Source: org_study_id

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