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Clinical Trials/NCT03052023
NCT03052023
Completed
Not Applicable

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

Assiut University1 site in 1 country60 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inguinal Hernioplasty
Sponsor
Assiut University
Enrollment
60
Locations
1
Primary Endpoint
operative time
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
April 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sulaiman Abdulqader Saif Alshameri

general surgeon

Assiut University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • recurrence(3 months, 6 months and one year)
  • post operative pain(immediately post operative and 6 ,12, 24 hours and two weeks post operative)
  • intraoperative injuries(intra operative)
  • intra operative bleeding(intraoperative)
  • post operative wound complication(2 weeks post operative ,3 ,6 and 12 months postoperative)
  • post operative chronic pain(follow up at 3 months , 6 months and one year for pain assessment by VAS)

Study Sites (1)

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