Bilateral Inguinal HerniaNCT04437784
Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia
A study testing Laparoscopic Trans-Abdominal Pre-Peritoneal, Open pre-peritoneal repair and Bilateral Lichtenstein repair in people with Bilateral Inguinal Hernia, run by Alexandria University.
Trial summary
The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Bilateral Inguinal Hernia
- What is being tested?
- Laparoscopic Trans-Abdominal Pre-Peritoneal, Open pre-peritoneal 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
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with painless uncomplicated primary bilateral inguinal hernias
Who cannot join
- Immune compromised patients
- Coagulopathy
- Chronic liver or renal disease
- High-risk patients unfit for major surgery (ASA III or IV),
- Massive scrotal hernias, Recurrent or Complicated hernias
- Groin pain due to any other pathology
- Previous infra-umbilical surgery
About this study
Official title: Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia; 3 Armed Randomized Study
The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia
Read the detailed description
This prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.
.
- Conditions
- Bilateral Inguinal Hernia
- Being tested
- Laparoscopic Trans-Abdominal Pre-Peritoneal, Open pre-peritoneal repair, Bilateral Lichtenstein repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Trans-Abdominal Pre-PeritonealProcedure or surgery
Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
Open pre-peritoneal repairProcedure or surgery
Open pre-peritoneal single mesh repair with suture fixation
Bilateral Lichtenstein repairProcedure or surgery
Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group)) | Active comparator | Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers Receives: Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal |
| Open Pre-Peritoneal Repair ( Open PP group) | Active comparator | Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation Receives: Procedure: Open pre-peritoneal repair |
| Bilateral Lichtenstein repair (LICHT group) | Active comparator | treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation 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: From skin incision until incision closure at the end of surgery
Postoperative pain after 24 hours
Pain intensity was assessed 24 hours after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
Measured: 24 hours after surgery
Postoperative pain after 7 days
Pain intensity was assessed 7 days after surgery 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
All complication related to surgery developed within 30 days after the surgery
Measured: Within 30 days after the surgery
Secondary outcomes (3)
Chronic Groin pain
Groin pain lasting for more than 3 months after surgery
Measured: After 3 months postoperatively
3 years hernia recurrence rate
Unilateral or bilateral - residual or recurrent hernia
Measured: within 3 years after surgery
Patient's satisfaction score
Patient satisfaction was assessed using 1 to 10 scale where: 9-10 means very satisfied, 7-8: satisfied, 6-7: neutral, 4-5: dissatisfied, <4: very dissatisfied
Measured: within 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 posted18 Jun 2020
- Study startJun 2014
- Primary completionJun 2017
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bilateral Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El Messiry, Alexandria University
- Investigators
- Mohamed Elmessiry, MD, PhD, Principal investigator, Assistant Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437784
- Sponsor's protocol ID
- 302765
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11525372Feliu 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 20960019
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 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 Study
- ClinicalTrials.gov ID
- NCT04437784
- Acronym / sponsor ID
- 302765
- Conditions
- Bilateral Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 18 Jun 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.
The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia
Detailed description
This prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group)) | Active comparator | Procedure: Laparoscopic Trans-Abdominal Pre-PeritonealBoth hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers |
| Open Pre-Peritoneal Repair ( Open PP group) | Active comparator | Procedure: Open pre-peritoneal repairBoth hernias were treated by open pre-peritoneal single mesh repair with suture fixation |
| Bilateral Lichtenstein repair (LICHT group) | Active comparator | Procedure: Bilateral Lichtenstein repairtreated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with painless uncomplicated primary bilateral inguinal hernias
Key exclusion criteria (7 listed)
- Immune compromised patients
- Coagulopathy
- Chronic liver or renal disease
- High-risk patients unfit for major surgery (ASA III or IV),
- Massive scrotal hernias, Recurrent or Complicated hernias
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 |
|---|---|---|
| Laparoscopic Trans-Abdominal Pre-PeritonealLaparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers | Procedure or surgery | Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group)) |
| Open pre-peritoneal repairOpen pre-peritoneal single mesh repair with suture fixation | Procedure or surgery | Open Pre-Peritoneal Repair ( Open PP group) |
| Bilateral Lichtenstein repairBilateral standard Lichtenstein repair using 2 separate meshes with suture fixation | Procedure or surgery | Bilateral Lichtenstein repair (LICHT group) |
Primary outcome
Operative time
Time frame: From skin incision until incision closure at the end of surgery
Operative time (in minutes)
Postoperative pain after 24 hours
Time frame: 24 hours after surgery
Pain intensity was assessed 24 hours after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
Postoperative pain after 7 days
Time frame: 7 days after surgery
Pain intensity was assessed 7 days after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
Early postoperative complications
Time frame: Within 30 days after the surgery
All complication related to surgery developed within 30 days after the surgery
3 secondary outcomes
Chronic Groin pain
Time frame: After 3 months postoperatively
3 years hernia recurrence rate
Time frame: within 3 years after surgery
Patient's satisfaction score
Time frame: within 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 18 Jun 2020.
- 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 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.
- Individual participant dataSharing planned: No
Related trials for Bilateral Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Ultrasound-guided Quadratus Lumborum Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Children Undergoing Elective Open Lower Abdominal Surgeries
Bilateral Inguinal Hernia Repair, Open Upper Abdominal Surgeries
RecruitingPhase 1
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
Inguinal Hernia Unilateral, Inguinal Hernia Bilateral
Not yet recruiting
Bilateral vs Unilateral Inguinal Hernia Repairs With an Asymptomatic Inguinal Hernia in Bilateral Hernias
Inguinal Hernia Bilateral
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, MD, PhD principal investigator
Assistant Professor of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Trans-Abdominal Pre-Peritoneal, Open pre-peritoneal repair and Bilateral Lichtenstein repair in people with Bilateral Inguinal Hernia, run by Alexandria University.
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 7 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 18 Jun 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: From skin incision until incision closure at the end of surgery). The study lists 4 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 NCT04437784, which also lists 2 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 18 Jun 2020.