Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia

Postoperative Complications Clinical Trial

Official title:

Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia 3 Armed Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357665
• Other study ID #: 0302765
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: March 2020

Study information

• Verified date: April 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2020
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Inguinal Hernia
• Hernia
• Hernia, Inguinal
• Postoperative Complications

Intervention

Procedure:
• Bilateral TAPP Repair
laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
• Open PP Repair
Open pre-peritoneal repair using single mesh fixed by sutures
• Bilateral Lichtenstein Repair
Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

References & Publications (3)

Feliu X, Clavería R, Besora P, Camps J, Fernández-Sallent E, Viñas 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. — View 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. Epub 2003 Jun 17. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Operative time (in minutes)	Same day of surgery
Primary	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)	7 days after surgery
Primary	Early postoperative complications	Any complications related to surgery developed within 30 days after the surgery	30 days after the surgery
Secondary	Chronic postoperative pain	Groin pain related to surgery lasting for more than 3 months after surgery	3 months after surgery
Secondary	Hernia recurrence	Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery	3 years after surgery