Inguinal HerniaNCT06380621
Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia
A study testing Totally Extra Peritoneal repair (TEP) repair in people with Inguinal Hernia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Totally Extra Peritoneal repair (TEP) repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNepal
- Study dates
- 15 Mar 2018to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age group of 16-55 years
- clinically diagnosed unilateral inguinal hernia
Who cannot join
- complicated hernia (obstructed and strangulated);
- past history of pelvic radiotherapy
- patient unfit for general anesthesia; and
- patient not giving consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Totally Extra Peritoneal repair (TEP) repair
- Keywords
- totally extra peritoneal (TEP)repair, Occult contralateral hernia, Inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally Extra Peritoneal repair (TEP) repairProcedure or surgery
TEP repair
| Study group | Role | What they receive |
|---|---|---|
| Bilateral TEP group | Experimental | Bilateral TEP repair Receives: Procedure: Totally Extra Peritoneal repair (TEP) repair |
| Unilateral TEP group | Active comparator | Unilateral TEP repair Receives: Procedure: Totally Extra Peritoneal repair (TEP) repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start15 Mar 2018
- Primary completion15 Feb 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bikash kumar sah, B.P. Koirala Institute of Health Sciences
- Investigators
- Rakesh kumar Gupta, Ms, Principal investigator, B. P. Koirala institute of health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380621
- Sponsor's protocol ID
- IRC/1386/018
- Status last verified
- Apr 2024
- First submitted
- 16 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32032331Bochkarev 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.
PubMed 17310298Pawanindra 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.
PubMed 20135181Tiwary 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.
PubMed 32984158Kockerling 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.
PubMed 25832474
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06380621
- Acronym / sponsor ID
- IRC/1386/018
- Conditions
- Inguinal Hernia
- Keywords
- totally extra peritoneal (TEP)repair, Occult contralateral hernia, Inguinal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral TEP group | Experimental | Procedure: Totally Extra Peritoneal repair (TEP) repairBilateral TEP repair |
| Unilateral TEP group | Active comparator | Procedure: Totally Extra Peritoneal repair (TEP) repairUnilateral TEP repair |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age group of 16-55 years
- clinically diagnosed unilateral inguinal hernia
Key exclusion criteria (4 listed)
- complicated hernia (obstructed and strangulated);
- past history of pelvic radiotherapy
- patient unfit for general anesthesia; and
- patient not giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totally Extra Peritoneal repair (TEP) repairTEP repair | Procedure or surgery | Bilateral TEP group, Unilateral TEP group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 32032331Kara 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.
- Background: PubMed 17310298Bochkarev 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.
- Background: PubMed 20135181Pawanindra 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.
- Background: PubMed 32984158Tiwary 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.
- Background: PubMed 25832474Kockerling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh kumar Gupta, Ms principal investigator
B. P. Koirala institute of health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Totally Extra Peritoneal repair (TEP) repair in people with Inguinal Hernia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380621, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.