Comparative Study Between Lap. Dual Approach, Lap. Trans Abdominal Pre-peritoneal and Lichtenstein Procedures

January 7, 2020 updated by: Sulaiman Abdulqader Saif Alshameri, Assiut University

Inguinal Hernioplasty: Comparative Study Between Laparoscopic Dual Approach, Laparoscopic Trans Abdominal Preperitoneal and Lichtenstein Procedures. A Prospective Randomized Controlled Trial

This study designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

inguinal hernioplasty is a procedures where synthetic mesh is used to strengthen the inguinal tissues sites for hernia repair different methods used which is either anterior approach (open Lichtenstein) or laparoscopic posterior approach through the abdomen (TAPP) comparing these two methods by new approach which is considered to some extent a modified TAPP by pneumo-dissection of pre-peritoneal space with abdominal approach by lap. repair

Study Type

Interventional

Enrollment (Actual)

60

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
      • Assiut, Egypt, 71515
        • Assiut University hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult male patient (older than 18y).
  • Not complicated.
  • No previous lower abdominal incisions (lower abdominal midline and lower paramedian incision in the same side of hernia).
  • No contraindication for general anesthesia.
  • Not recurrent.

Exclusion Criteria:

  • any one not in fulfill inclusion criteria

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group A (dual approach lap hernioplasty)
dual approach laparoscopic inguinal hernioplasty by combination of TAPP (group B) and pneumo-dissection preperitoneal instead of sharp dissection
Procedure: dual approach laparoscopic inguinal hernioplasty
after pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached
ACTIVE_COMPARATOR: group B (TAPP)
trans-abdominal preperitoneal hernioplasty (TAPP) after induction of pneumoperitoneum through peritoneal approach peritoneal incision and preperitoneal dissection then mesh fixation done
Procedure: TAPP
pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation
ACTIVE_COMPARATOR: group C (Lichtenstein hernioplasty)
open inguinal hernioplasty (lichtenstein) repair through inguinal incision and dissection of the sac anteriorly , excision of the sac and then mesh fixation in the posterior wall of inguinal canal
Procedure: (lichtenstein) repair
inguinal incision is done and inguinal canal approach anteriorly and then sac dissection and excision then mesh fixation to posterior wall and closure the incision in layers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure.

operative time will be measured in minutes for each procedure.and comparing three groups ( dual approach , TAPP and Lichtenstein ) in operative time which determined as follow:

  • from the inflation of the abdomen till deflation and port closure
  • for Lichtenstein from skin incision to skin closure
from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative injuries
Time Frame: intra operative
abdominal visceral injuries cord structure injuries
intra operative
intra operative bleeding
Time Frame: intraoperative
mild bleeding and oozing controlled by cautery bleeding from inferior epigastric artery or testicular artery major vascular injury
intraoperative
post operative pain
Time Frame: immediately post operative and 6 ,12, 24 hours and two weeks post operative
pain measured by visual analog scale from 0 no pain to 10 the worst pain ever.
immediately post operative and 6 ,12, 24 hours and two weeks post operative
post operative wound complication
Time Frame: 2 weeks post operative ,3 ,6 and 12 months postoperative
wound seroma , hematoma either small with conservative treatment and large need intervention wound infection either superficial skin and S.C. or mesh infection
2 weeks post operative ,3 ,6 and 12 months postoperative
post operative chronic pain
Time Frame: follow up at 3 months , 6 months and one year for pain assessment by VAS
post operative paraesthesia , bricking pain, dull-aching pain. measured by visual analog scale (VAS) from 0 no pain to 10 the worst pain ever
follow up at 3 months , 6 months and one year for pain assessment by VAS
recurrence
Time Frame: 3 months, 6 months and one year
post operative inguinal swelling confirmed clinically as a recurrent hernia
3 months, 6 months and one year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: mostafa A. hamad, professor, Assiut university hospital faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2016

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (ACTUAL)

February 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IHPP3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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