search
Back to results

Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

Primary Purpose

Bilateral Inguinal Hernia, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral TAPP Repair
Open PP Repair
Bilateral Lichtenstein Repair
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Inguinal Hernia focused on measuring Bilateral Inguinal Hernia, Laparoscopic versus open mesh repair, Operative outcomes, Recurrence

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years

Exclusion Criteria:

  1. - Immune compromised patients,
  2. - Morbid obesity (BMI > 35 kg/m2)
  3. - Chronic liver or renal disease
  4. - Coagulopathy
  5. - High-risk patients unfit for major surgery (ASA III or IV)
  6. - Recurrent hernias
  7. - Complicated hernias
  8. - Massive scrotal hernias
  9. - Previous infra-umbilical surgery
  10. Persistent groin pain due to other causes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Lap TAPP Group

    Open PP Group

    Bilateral LICHT Group

    Arm Description

    Patients treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers

    Patients treated by open preperitoneal single mesh repair fixated using sutures

    Patients treated by standard bilateral Lichtenstein repair using 2 separate meshes fixed by sutures

    Outcomes

    Primary Outcome Measures

    Operative time
    Operative time (in minutes)
    Postoperative pain 7 days after surgery
    Pain intensity was assessed using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
    Early postoperative complications
    Any complications related to surgery developed within 30 days after the surgery

    Secondary Outcome Measures

    Chronic postoperative pain
    Groin pain related to surgery lasting for more than 3 months after surgery
    Hernia recurrence
    Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery

    Full Information

    First Posted
    April 19, 2020
    Last Updated
    April 19, 2020
    Sponsor
    University of Alexandria
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04357665
    Brief Title
    Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia
    Official Title
    Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia 3 Armed Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    March 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alexandria

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Currently, there is a controversy regarding the best approach for simultaneous repair of bilateral inguinal hernia. The aim of this study was to compare the outcome of laparoscopic versus open repair of bilateral inguinal hernia
    Detailed Description
    This prospective randomized study included 120 consecutive patients with bilateral primary inguinal hernia treated at Alexandria university hospital in the period between June 2014 and February 2017. Patients were randomized by sealed envelopes into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes, Group II treated by open preperitoneal mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, pain, hospital stay, return to normal activity and work, chronic groin pain, patient's satisfaction and 3 years recurrence rate. Statistical Analysis: Numerical data in both groups was expressed as mean ± standard deviation (SD) and compared using One-way analysis of variance while categorical data was expressed as percentages and compared using Chi-squared test. Logistic regression test was used to determine predictors of postoperative complications. Differences were considered significant at p <0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bilateral Inguinal Hernia, Postoperative Complications
    Keywords
    Bilateral Inguinal Hernia, Laparoscopic versus open mesh repair, Operative outcomes, Recurrence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This prospective study included 120 consecutive patients with bilateral primary inguinal hernia managed by simultaneous bilateral repair. Patients were randomized by sealed opaque envelopes containing computer generated random numbers into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes (Lap TAPP), Group II treated by open preperitoneal mesh repair with mesh fixation (Open PP), while Group III treated by standard bilateral Lichtenstein repair (LICHT group).
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lap TAPP Group
    Arm Type
    Active Comparator
    Arm Description
    Patients treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
    Arm Title
    Open PP Group
    Arm Type
    Active Comparator
    Arm Description
    Patients treated by open preperitoneal single mesh repair fixated using sutures
    Arm Title
    Bilateral LICHT Group
    Arm Type
    Active Comparator
    Arm Description
    Patients treated by standard bilateral Lichtenstein repair using 2 separate meshes fixed by sutures
    Intervention Type
    Procedure
    Intervention Name(s)
    Bilateral TAPP Repair
    Intervention Description
    laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
    Intervention Type
    Procedure
    Intervention Name(s)
    Open PP Repair
    Intervention Description
    Open pre-peritoneal repair using single mesh fixed by sutures
    Intervention Type
    Procedure
    Intervention Name(s)
    Bilateral Lichtenstein Repair
    Intervention Description
    Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures
    Primary Outcome Measure Information:
    Title
    Operative time
    Description
    Operative time (in minutes)
    Time Frame
    Same day of surgery
    Title
    Postoperative pain 7 days after surgery
    Description
    Pain intensity was assessed using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
    Time Frame
    7 days after surgery
    Title
    Early postoperative complications
    Description
    Any complications related to surgery developed within 30 days after the surgery
    Time Frame
    30 days after the surgery
    Secondary Outcome Measure Information:
    Title
    Chronic postoperative pain
    Description
    Groin pain related to surgery lasting for more than 3 months after surgery
    Time Frame
    3 months after surgery
    Title
    Hernia recurrence
    Description
    Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery
    Time Frame
    3 years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years Exclusion Criteria: - Immune compromised patients, - Morbid obesity (BMI > 35 kg/m2) - Chronic liver or renal disease - Coagulopathy - High-risk patients unfit for major surgery (ASA III or IV) - Recurrent hernias - Complicated hernias - Massive scrotal hernias - Previous infra-umbilical surgery Persistent groin pain due to other causes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Elmessiry
    Organizational Affiliation
    Ass. Professor of Surgery
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ahmed Gebaly
    Organizational Affiliation
    Ass. Professor of Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No consent to share IPD
    Citations:
    PubMed Identifier
    20960019
    Citation
    Feliu X, Claveria R, Besora P, Camps J, Fernandez-Sallent E, Vinas X, Abad JM. Bilateral inguinal hernia repair: laparoscopic or open approach? Hernia. 2011 Feb;15(1):15-8. doi: 10.1007/s10029-010-0736-2. Epub 2010 Oct 21.
    Results Reference
    background
    PubMed Identifier
    11525372
    Citation
    Sarli L, Iusco DR, Sansebastiano G, Costi R. Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach. Surg Laparosc Endosc Percutan Tech. 2001 Aug;11(4):262-7. doi: 10.1097/00129689-200108000-00007.
    Results Reference
    background
    PubMed Identifier
    12802653
    Citation
    Mahon D, Decadt B, Rhodes M. Prospective randomized trial of laparoscopic (transabdominal preperitoneal) vs open (mesh) repair for bilateral and recurrent inguinal hernia. Surg Endosc. 2003 Sep;17(9):1386-90. doi: 10.1007/s00464-002-9223-x. Epub 2003 Jun 17.
    Results Reference
    background

    Learn more about this trial

    Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

    We'll reach out to this number within 24 hrs