Clinical trial NCT04357665: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Inguinal Hernia
Postoperative Complications
Keywords: Bilateral Inguinal Hernia
Laparoscopic versus open mesh repair
Operative outcomes
Recurrence
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time
timeFrame: Same day of surgery
measure: Postoperative pain 7 days after surgery
timeFrame: 7 days after surgery
measure: Early postoperative complications
timeFrame: 30 days after the surgery
Secondary outcomes:
measure: Chronic postoperative pain
timeFrame: 3 months after surgery
measure: Hernia recurrence
timeFrame: 3 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Ass. Professor of Surgery
name: Mohamed Elmessiry
role: PRINCIPAL_INVESTIGATOR
affiliation: Ass. Professor of Surgery
name: Ahmed Gebaly
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.