Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia
A Comparative Longitudinal Study Between Bilateral Totally Extraperitoneal Repair and Unilateral Totally Extraperitoneal Repair Among Patients of Unilateral Inguinal Hernia at a Tertiary Care Hospital in Eastern Nepal
The goal of this clinical trial is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed by laparoscopic bilateral TEP repair in all cases with a contralateral occult hernia and to compare complications, recurrence rates, postoperative pain, and operative duration with prospectively performed unilateral repairs in young to middle-aged patients presenting with unilateral hernias in the surgery outpatient department.
The main questions it aims to answer are:
- To compare complications, recurrence rates, postoperative pain, and operative duration between both groups.
- Incidence of occult contralateral hernia Patients attending the OPD for unilateral inguinal hernia were counseled about the trial and fully encouraged to understand the difference between two procedures for unilateral hernia: bilateral exploration and bilateral TEP repair, upon which if a contralateral occult inguinal hernia was observed, documented, and controls were taken from the patients who denied bilateral exploration and underwent unilateral TEP repair. The allotment of patients was done in two groups of 30 patients each.
Researchers will compare Group A( bilateral TEP) with Group B (unilateral TEP) to see if complications, recurrence rates, postoperative pain, and operative duration occur in each group
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction Today, laparoscopic total extraperitoneal (TEP) surgery has emerged as the preferred and standard approach in today's era of technology, owing to the various benefits of laparoscopic surgery. Patients with unilateral inguinal hernia have a lifetime risk of 33% of developing hernia on the contralateral side.1 A study by Bochkarev, V. and Lal, P. et al. showed approximately 22% of bilateral defects in patients with unilateral inguinal hernia at TEP. 2,3 Another study found reasonable (20-25%) chance of discovering an occult contralateral hernia on exploration of the clinically asymptomatic side in unilateral hernias.3 Moreover, Studies have reported an incidence rate of 5%-58% for occult contralateral hernias at the time.4 The patient is at high risk of fibrous adhesions, bowel and bladder injury, and port site hernia if repeat TEP is planned for contralateral inguinal hernia repair. Thus, performing a bilateral repair for a unilateral hernia with/without an occult contralateral defect renders the patient free of the possibility of developing a contralateral primary inguinal hernia later in life, and this can be done in a single sitting or a single hospital stay. The patient holds various benefits (decreased chances of repeat anesthesia-related complications, risk of intra-peritoneal adhesions, bowel perforation, monitoring advantage) except for a minor increase in surgery time.5
Laparoscopic inguinal hernia repair is the standard procedure in our department and is highly demanding, complex, and at times controversial. No data is available till date regarding operative duration, complications, and recurrence rates in the Nepalese population. So, this study is designed to evaluate the constraints of this problem in the context of our developing country, measuring the outcomes between these two groups. The purpose of this study is to have a specific management plan for laparoscopic inguinal hernia repair, provide rationale for a current management plan, and try to formulate a protocol for our hospital. Whether clinically diagnosed unilateral inguinal hernias allow bilateral exploration, a bilateral repair would benefit the patient in the long term or not, and we anticipate evolving policy changes in the days ahead.
Method:
A total of 60 patients were included in this prospective longitudinal study from March 2018 to March 2019. Patients attending the OPD for unilateral inguinal hernia were counseled about the trial. Patients who gave consent for bilateral inguinal exploration and repair were kept in Group A, and those who did not consent for bilateral exploration and underwent unilateral repair were kept in Group B. The allotment of patients was done in two groups of 30 patients each.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Koshi
-
Dharān Bāzār, Koshi, Nepal, 56700
- Bikash Kumar Sah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age group of 16-55 years
- clinically diagnosed unilateral inguinal hernia
Exclusion Criteria:
- complicated hernia (obstructed and strangulated);
- past history of pelvic radiotherapy
- patient unfit for general anesthesia; and
- patient not giving consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bilateral TEP group
Bilateral TEP repair
|
TEP repair
|
|
Active Comparator: Unilateral TEP group
Unilateral TEP repair
|
TEP repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair.
Time Frame: 6 months
|
The postoperative pain was recorded by a pictorial Visual Analogue Scale (VAS) at 6 hours, 12 hours, and 24 hours during the hospital stay, and during follow up in the outpatient department on the 10th day, 1 month, 3 months, and 6 months, respectively.
|
6 months
|
|
To measure incidence of intra- and post-operative complication between patients of unilateral and bilateral TEP repair
Time Frame: 6 months
|
intraoperative complications: Visceral injury, Subcutaneous emphysema Postoperative: seroma, wound infection, and recurrence assessed during the hospital stay and during follow-up in the outpatient department on the 10th day, 1 month, 3 months, and 6 months, respectively.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rakesh Kumar Gupta, MS, B. P. Koirala Institute of Health Science
Publications and helpful links
General Publications
- Kara H, Arikan AE, Dulgeroglu O, Moldur DE, Uras C. Management of Occult Contralateral Inguinal Hernia: Diagnosis and Treatment With Laparoscopic Totally Extra Peritoneal Repair. Surg Laparosc Endosc Percutan Tech. 2020 Jun;30(3):245-248. doi: 10.1097/SLE.0000000000000765.
- Bochkarev V, Ringley C, Vitamvas M, Oleynikov D. Bilateral laparoscopic inguinal hernia repair in patients with occult contralateral inguinal defects. Surg Endosc. 2007 May;21(5):734-6. doi: 10.1007/s00464-007-9196-x. Epub 2007 Feb 20.
- Pawanindra Lal, Philips P, Chander J, Ramteke VK. Is unilateral laparoscopic TEP inguinal hernia repair a job half done? The case for bilateral repair. Surg Endosc. 2010 Jul;24(7):1737-45. doi: 10.1007/s00464-009-0841-4. Epub 2010 Feb 5.
- Tiwary SK, Kumar S, More R, Shankar V, Kumar S, Dwivedi AND. A study of contralateral occult inguinal hernia in adult male patients undergoing total extraperitoneal herniorraphy. J Family Med Prim Care. 2020 Jun 30;9(6):2975-2979. doi: 10.4103/jfmpc.jfmpc_207_20. eCollection 2020 Jun.
- Kockerling F, Schug-Pass C, Adolf D, Keller T, Kuthe A. Bilateral and Unilateral Total Extraperitoneal Inguinal Hernia Repair (TEP) have Equivalent Early Outcomes: Analysis of 9395 Cases. World J Surg. 2015 Aug;39(8):1887-94. doi: 10.1007/s00268-015-3055-z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRC/1386/018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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