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
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
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
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
NCT ID
NCT04357665
First Posted
April 19, 2020
Last Updated
April 19, 2020
Sponsor
University of Alexandria
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
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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
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Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia
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