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

NCT06380621 | Completed DMC

• 1 other identifier: IRC/1386/018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inguinal Hernia

Keywords

totally extra peritoneal (TEP)repair; Occult contralateral hernia; Inguinal hernia

Outcome Measures

Primary Outcomes (2)

• To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair.

  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

  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

Study Arms (2)

Bilateral TEP group

EXPERIMENTAL

Bilateral TEP repair

Procedure: Totally Extra Peritoneal repair (TEP) repair

Unilateral TEP group

ACTIVE COMPARATOR

Unilateral TEP repair

Procedure: Totally Extra Peritoneal repair (TEP) repair

Interventions

Totally Extra Peritoneal repair (TEP) repair PROCEDURE

TEP repair

Bilateral TEP group; Unilateral TEP group

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age group of 16-55 years
• clinically diagnosed unilateral inguinal hernia

You may not qualify if:

• complicated hernia (obstructed and strangulated);
• past history of pelvic radiotherapy
• patient unfit for general anesthesia; and
• patient not giving consent

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Bikash Kumar Sah

Dharān, Koshi, 56700, Nepal

Location

Related Publications (5)

• 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.

  PMID: 32032331 BACKGROUND

• 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.

  PMID: 17310298 BACKGROUND

• 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.

  PMID: 20135181 BACKGROUND

• 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.

  PMID: 32984158 BACKGROUND

• 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.

  PMID: 25832474 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tetraethylpyrazine; Wound Healing

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Rakesh kumar Gupta, Ms

  B. P. Koirala institute of health science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture (General Surgery)

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: April 24, 2024
• Study Start: March 15, 2018
• Primary Completion: February 15, 2019
• Study Completion: March 15, 2019
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

NE (1)