Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

Bilateral Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437784
• Other study ID #: 302765
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 2020

Study information

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

Clinical 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

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.

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2020
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with painless uncomplicated primary bilateral inguinal hernias

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bilateral Inguinal Hernia
• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Laparoscopic Trans-Abdominal Pre-Peritoneal
Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
• Open pre-peritoneal repair
Open pre-peritoneal single mesh repair with suture fixation
• Bilateral Lichtenstein repair
Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

References & Publications (2)

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

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)	From skin incision until incision closure at the end of surgery
Primary	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)	24 hours after surgery
Primary	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)	7 days after surgery
Primary	Early postoperative complications	All complication related to surgery developed within 30 days after the surgery	Within 30 days after the surgery
Secondary	Chronic Groin pain	Groin pain lasting for more than 3 months after surgery	After 3 months postoperatively
Secondary	3 years hernia recurrence rate	Unilateral or bilateral - residual or recurrent hernia	within 3 years after surgery
Secondary	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	within 3 years after surgery