Skip to main content
OpenTrials
Completed

NCT Number: NCT03052023

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inguinal Hernioplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university hospital

Asyut, 71515, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dual approach laparoscopic inguinal hernioplasty

Procedure

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

TAPP

Procedure

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

(lichtenstein) repair

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

Primary outcomes

  1. 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

  1. intraoperative injuries

    Time frame: intra operative

    abdominal visceral injuries cord structure injuries

  2. intra operative bleeding

    Time frame: intraoperative

    mild bleeding and oozing controlled by cautery bleeding from inferior epigastric artery or testicular artery major vascular injury

  3. 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.

  4. 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

  5. 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

  6. recurrence

    Time frame: 3 months, 6 months and one year

    post operative inguinal swelling confirmed clinically as a recurrent hernia

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 14, 2017
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.