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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-04-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Inguinal Hernioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

comparative study between three procedures of inguinal hernioplasty; open (LICHTENSTEIN), TAPP, and laparoscopic DUAL APPROACH (modified TAPP)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

this is a randomized trial where the participants are selected randomly to each of the previous three groups , and the post operative assessment of complication and pain done by different surgical residents whom are not informed about the groups of study.

Study Groups

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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

Group Type EXPERIMENTAL

dual approach laparoscopic inguinal hernioplasty

Intervention Type PROCEDURE

after pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached

group B (TAPP)

trans-abdominal preperitoneal hernioplasty (TAPP) after induction of pneumoperitoneum through peritoneal approach peritoneal incision and preperitoneal dissection then mesh fixation done

Group Type ACTIVE_COMPARATOR

TAPP

Intervention Type PROCEDURE

pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation

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

Group Type ACTIVE_COMPARATOR

(lichtenstein) repair

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

TAPP

pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No