Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04437784

Enrollment

180

Registered

2020-06-18

Start date

2014-06-30

Completion date

2020-06-30

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Inguinal Hernia

Brief 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

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. .

Interventions

PROCEDURELaparoscopic Trans-Abdominal Pre-Peritoneal

Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers

PROCEDUREOpen pre-peritoneal repair

Open pre-peritoneal single mesh repair with suture fixation

PROCEDUREBilateral Lichtenstein repair

Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Sealed opaque envelopes containing computer generated random numbers

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Operative time	From skin incision until incision closure at the end of surgery	Operative time (in minutes)
Postoperative pain after 24 hours	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	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	Within 30 days after the surgery	All complication related to surgery developed within 30 days after the surgery

Secondary

Measure	Time frame	Description
3 years hernia recurrence rate	within 3 years after surgery	Unilateral or bilateral - residual or recurrent hernia
Patient's satisfaction score	within 3 years after surgery	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
Chronic Groin pain	After 3 months postoperatively	Groin pain lasting for more than 3 months after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026