Laparscopic Hernioplasty in Recurrent Inguinal Hernia

September 21, 2023 updated by: Islam Hisham, Mansoura University

A Prospective Randomized Pilot Study Comparing Transabdominal Properitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Laparoscopic Inguinal Hernioplasty in Recurrent Inguinal Hernia

The purpose of this study was to compare between laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal hernia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective in this study was to compare postoperative pain between the TAPP group and the TEP group. The secondary objective was to compare operative time, intraoperative complications (bleeding, bowel injury, vascular injury), postoperative complications (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with possible risk factors which include gender, age, BMI ,cord lipomas and location of the hernia.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University Hospitl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with unilateral or bilateral recurrent inguinal hernias.
  • Patients between 18 and 70 years old
  • Fit for anesthesia.
  • Agree to participate in the study
  • Both genders were included.

Exclusion Criteria:

  • Unfitness for general anesthesia and operation.
  • Age < 18 years or >70 years.
  • Complicated hernias (acute irreducible, obstruction or strangulation).
  • The presence of mental or psychological disorders.
  • Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transabdominal preperitoneal (TAPP)
patients with recurrent inguinal hernia who had Transabdominal preperitoneal (TAPP) approach
Procedure: Transabdominal preperitoneal (TAPP) using polyprolene mesh
Transabdominal preperitoneal (TAPP) approach for recurrent inguinal hernia using polyprolene mesh
Active Comparator: Total extraperitoneal (TEP) approach
patients with recurrent inguinal hernia who had Total extraperitoneal (TEP) approach
Procedure: Total extraperitoneal (TEP) hernioplasty using polyprolene mesh
Total extraperitoneal (TEP) approach for recurrent inguinal hernia using polyprolene mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 6 months
by use of visual analog scale (VAS) where (0) refereed to no pain and (10) refereed to the severest pain.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 6 months
operative time by minutes was reported to get mean and standard deviation
6 months
complications
Time Frame: 6 months
complications will be described as number and percentages in each group
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Islam Hisham, MSc, Mansoura University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.21.03.439

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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