Bilateral Inguinal Hernia, Postoperative Complications
Conditions
Keywords
Bilateral Inguinal Hernia, Laparoscopic versus open mesh repair, Operative outcomes, Recurrence
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.
Interventions
PROCEDUREBilateral TAPP Repair
laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
PROCEDUREOpen PP Repair
Open pre-peritoneal repair using single mesh fixed by sutures
PROCEDUREBilateral Lichtenstein Repair
Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures
Sponsors
University of Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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).
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Same day of surgery | Operative time (in minutes) |
| Postoperative pain 7 days after surgery | 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) |
| Early postoperative complications | 30 days after the surgery | Any complications related to surgery developed within 30 days after the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic postoperative pain | 3 months after surgery | Groin pain related to surgery lasting for more than 3 months after surgery |
| Hernia recurrence | 3 years after surgery | Unilateral or bilateral - residual or recurrent hernia within 3 years after surgery |
Outcome results
None listed