Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380621
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-03-16
Brief Title:
Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia
Sponsor:
BP Koirala Institute of Health Sciences
Organization:
BP Koirala Institute of Health Sciences
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Introduction Today laparoscopic total extraperitoneal TEP surgery has emerged as the preferred and standard approach in todays 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 side1 A study by Bochkarev V and Lal P et al showed approximately 22 of bilateral defects in patients with unilateral inguinal hernia at TEP 23 Another study found reasonable 20-25 chance of discovering an occult contralateral hernia on exploration of the clinically asymptomatic side in unilateral hernias3 Moreover Studies have reported an incidence rate of 5-58 for occult contralateral hernias at the time4 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 withwithout 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 time5
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None