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

Not Applicable

Completed

• Conditions: Inguinal Hernioplasty
• Interventions: Procedure: dual approach laparoscopic inguinal hernioplasty; Procedure: TAPP; Procedure: (lichtenstein) repair

• Registration Number: NCT03052023
• Lead Sponsor: Assiut University

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

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A (dual approach lap hernioplasty)	dual approach laparoscopic inguinal hernioplasty	dual approach laparoscopic inguinal hernioplasty by combination of TAPP (group B) and pneumo-dissection preperitoneal instead of sharp dissection
group B (TAPP)	TAPP	trans-abdominal preperitoneal hernioplasty (TAPP) after induction of pneumoperitoneum through peritoneal approach peritoneal incision and preperitoneal dissection then mesh fixation done
group C (Lichtenstein hernioplasty)	(lichtenstein) repair	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

Primary Outcome Measures

Name	Time	Method
operative time	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 Outcome Measures

Name	Time	Method
recurrence	3 months, 6 months and one year	post operative inguinal swelling confirmed clinically as a recurrent hernia
post operative pain	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.
intraoperative injuries	intra operative	abdominal visceral injuries cord structure injuries
intra operative bleeding	intraoperative	mild bleeding and oozing controlled by cautery bleeding from inferior epigastric artery or testicular artery major vascular injury
post operative wound complication	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
post operative chronic pain	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

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt