NCT03721575

Completed

Randomized Trial on Scarpa Fascia Preservation During Hernio...

Mansoura University Source

Compare

Other study identifiers

Sponsor study identifier

mansoura61

Study Type

interventional

Actual enrollment (reported)

50

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 1, 2016

Actual (reported)

Primary Completion

January 1, 2018

Actual (reported)

Study Completion

October 1, 2018

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 50 participants
Study completion date: October 1, 2018
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2016
Actual (reported)
Primary Completion
January 1, 2018
Actual (reported)
Study Completion
October 1, 2018
Actual (reported)
First Submitted
October 25, 2018
Actual (reported)
First Posted
October 26, 2018
Actual (reported)

Last Updated: October 26, 2018
Status Verified: October 2018
Last Update Submitted: October 25, 2018

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

Volume of postoperative drainage
The volume of fluid drained through suction drains per 24 hours
Two weeks after surgery

Study Arms (2)

Scarpa's preserving hernio-abdominoplasty

ACTIVE COMPARATOR

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

Procedure: Scarpa's preserving hernio-abdominoplasty

Classical hernio-abdominoplasty

ACTIVE COMPARATOR

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

Procedure: Classical hernio-abdominoplasty

Interventions

Scarpa's preserving hernio-abdominoplastyProcedure

Scarpa's fascia is preserved during hernio-abdominoplasty

Scarpa's preserving hernio-abdominoplasty

Classical hernio-abdominoplastyProcedure

Scarpa's fascia is removed during hernio-abdominoplasty

Classical hernio-abdominoplasty

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

Mansoura University
Otherlead

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

Sameh H Emile
Mansoura University
PRINCIPAL INVESTIGATOR

Enrollment

50 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Lecturer of general surgery

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 26, 2018

Study Start

January 1, 2016

Actual (reported)

NCT02379858

Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair

Not ApplicableTerminated

NCT02616718

Incisional Hernia Progression Over Time

Not ApplicableCompleted

NCT02408458

Miromatrix Biological Mesh for Ventral Hernia Repair

Not ApplicableWithdrawn

NCT04355819

Patient Centered Outcomes Study

Not ApplicableCompleted

NCT02451176

Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias

Not ApplicableCompleted

NCT02363790

Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial

Not ApplicableUnknown

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

January 1, 2018

Actual (reported)

Study Completion

October 1, 2018

Actual (reported)

Last Updated

October 26, 2018

Record last verified: 2018-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03721575
Data provider: ClinicalTrials.gov
Source updated: 2018-10-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:13 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Scarpa's preserving hernio-abdominoplasty

Classical hernio-abdominoplasty

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record