Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia; 3 Armed Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bilateral Inguinal Hernia
- Sponsor
- Alexandria University
- Enrollment
- 180
- Primary Endpoint
- Operative time
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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. .
Investigators
Mohamed El Messiry
Assistant professor of Surgery
Alexandria University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Operative time
Time Frame: From skin incision until incision closure at the end of surgery
Operative time (in minutes)
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
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)
Secondary Outcomes
- 3 years hernia recurrence rate(within 3 years after surgery)
- Patient's satisfaction score(within 3 years after surgery)
- Chronic Groin pain(After 3 months postoperatively)