An interventional study of Totally Extra Peritoneal repair (TEP) repair in Inguinal Hernia, sponsored by B.P. Koirala Institute of Health Sciences. Completed at 1 site in Nepal. Open to participants aged 16 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by B.P. Koirala Institute of Health Sciences · Not applicable, Interventional, and Treatment
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:
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
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →B.P. Koirala Institute of Health Sciences is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Bilateral TEP repair
Procedure: Totally Extra Peritoneal repair (TEP) repair
Unilateral TEP repair
Procedure: Totally Extra Peritoneal repair (TEP) repair
TEP repair
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.
Time frame: 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.
Time frame: 6 months
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B.P. Koirala Institute of Health Sciences