Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia

B

B.P. Koirala Institute of Health Sciences

Status

Completed

Conditions

Inguinal Hernia

Treatments

Procedure: Totally Extra Peritoneal repair (TEP) repair

Study type

Interventional

Funder types

Other

Identifiers

NCT06380621
IRC/1386/018

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

16 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. age group of 16-55 years
  2. clinically diagnosed unilateral inguinal hernia

Exclusion criteria

  1. complicated hernia (obstructed and strangulated);
  2. past history of pelvic radiotherapy
  3. patient unfit for general anesthesia; and
  4. patient not giving consent

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Bilateral TEP group
Experimental group
Description:
Bilateral TEP repair
Treatment:
Procedure: Totally Extra Peritoneal repair (TEP) repair
Unilateral TEP group
Active Comparator group
Description:
Unilateral TEP repair
Treatment:
Procedure: Totally Extra Peritoneal repair (TEP) repair

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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