Bilateral Inguinal HerniaNCT04357665
Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia
A study testing Bilateral TAPP Repair, Open PP Repair and Bilateral Lichtenstein Repair in people with Bilateral Inguinal Hernia and Postoperative Complications, run by University of Alexandria.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bilateral Inguinal Hernia, Postoperative Complications
- What is being tested?
- Bilateral TAPP Repair, Open PP Repair and Bilateral Lichtenstein Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years
Who cannot join
- - 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
Show all 10Show fewer
- - Complicated hernias
- - Massive scrotal hernias
- - Previous infra-umbilical surgery
- Persistent groin pain due to other causes
About this study
Official title: Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia 3 Armed Randomized Trial
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
Read the 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.
- Being tested
- Bilateral TAPP Repair, Open PP Repair, Bilateral Lichtenstein Repair
- Keywords
- Bilateral Inguinal Hernia, Laparoscopic versus open mesh repair, Operative outcomes, Recurrence
- Medical subject headings
- Postoperative Complications, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral TAPP RepairProcedure or surgery
laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
Open PP RepairProcedure or surgery
Open pre-peritoneal repair using single mesh fixed by sutures
Bilateral Lichtenstein RepairProcedure or surgery
Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures
| Study group | Role | What they receive |
|---|---|---|
| Lap TAPP Group | Active comparator | Patients treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers Receives: Procedure: Bilateral TAPP Repair |
| Open PP Group | Active comparator | Patients treated by open preperitoneal single mesh repair fixated using sutures Receives: Procedure: Open PP Repair |
| Bilateral LICHT Group | Active comparator | Patients treated by standard bilateral Lichtenstein repair using 2 separate meshes fixed by sutures Receives: Procedure: Bilateral Lichtenstein Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time (in minutes)
Measured: Same day of surgery
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)
Measured: 7 days after surgery
Early postoperative complications
Any complications related to surgery developed within 30 days after the surgery
Measured: 30 days after the surgery
Secondary outcomes (2)
Chronic postoperative pain
Groin pain related to surgery lasting for more than 3 months after surgery
Measured: 3 months after surgery
Hernia recurrence
Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study startJun 2014
- Primary completionJan 2017
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bilateral Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El Messiry, University of Alexandria
- Investigators
- Mohamed Elmessiry, Principal investigator, Ass. Professor of SurgeryAhmed Gebaly, Principal investigator, Ass. Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357665
- Sponsor's protocol ID
- 0302765
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No consent to share IPD
Publications
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.
PubMed 20960019Sarli 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.
PubMed 11525372Mahon 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.
PubMed 12802653
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia 3 Armed Randomized Trial
- ClinicalTrials.gov ID
- NCT04357665
- Acronym / sponsor ID
- 0302765
- Keywords
- Bilateral Inguinal Hernia, Laparoscopic versus open mesh repair, Operative outcomes, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Lap TAPP Group | Active comparator | Procedure: Bilateral TAPP RepairPatients treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers |
| Open PP Group | Active comparator | Procedure: Open PP RepairPatients treated by open preperitoneal single mesh repair fixated using sutures |
| Bilateral LICHT Group | Active comparator | Procedure: Bilateral Lichtenstein RepairPatients treated by standard bilateral Lichtenstein repair using 2 separate meshes fixed by sutures |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years
Key exclusion criteria (10 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral TAPP Repairlaparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers | Procedure or surgery | Lap TAPP Group |
| Open PP RepairOpen pre-peritoneal repair using single mesh fixed by sutures | Procedure or surgery | Open PP Group |
| Bilateral Lichtenstein RepairBilateral Lichtenstein Repair using 2 separate meshes fixed by sutures | Procedure or surgery | Bilateral LICHT Group |
Primary outcome
Operative time
Time frame: Same day of surgery
Operative time (in minutes)
Postoperative pain 7 days after surgery
Time frame: 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
Time frame: 30 days after the surgery
Any complications related to surgery developed within 30 days after the surgery
2 secondary outcomes
Chronic postoperative pain
Time frame: 3 months after surgery
Hernia recurrence
Time frame: 3 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Background: PubMed 20960019Feliu 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.
- Background: PubMed 11525372Sarli 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.
- Background: PubMed 12802653Mahon 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.
- Individual participant dataSharing planned: No. No consent to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Elmessiry principal investigator
Ass. Professor of Surgery
Ahmed Gebaly principal investigator
Ass. Professor of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral TAPP Repair, Open PP Repair and Bilateral Lichtenstein Repair in people with Bilateral Inguinal Hernia and Postoperative Complications, run by University of Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Same day of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357665, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.