Inguinal HerniaNCT05107986
Laparoscopy in Complicated Groin Hernia
An observational study of Inguinal Hernia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
This study assessed the outcomes of laparoscopic repair in complicated groin hernia. Laparoscopic approach in cases of complicated groin hernia can achieve desirable patient outcomes without major complications, provided good patient selection and expertise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- laparoscopic repair
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteNepal
- Study dates
- 1 Sep 2017to 30 Sep 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of complicated groin hernia
Who may be able to join
- Patients with age greater than 18 years with diagnosis of complicated groin hernia
Who cannot join
- Patients with features of peritonitis, history of previous abdominal surgery and those unfit for general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Laparoscopic Repair in Complicated Groin Hernia: a Single Institutional Based Cohort Study in Nepal
This study assessed the outcomes of laparoscopic repair in complicated groin hernia. Laparoscopic approach in cases of complicated groin hernia can achieve desirable patient outcomes without major complications, provided good patient selection and expertise. This study provides an insight to the outcomes from the procedure in low resource setting of Nepal.
- Conditions
- Inguinal Hernia
- Being tested
- laparoscopic repair
- Keywords
- Complicated groin hernia, Totally extra-peritoneal repair, Transabdominal preperitoneal repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic repairProcedure or surgery
All patients of cohort underwent laparoscopic repair.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with complicated groin hernia | Not described Receives: Procedure: laparoscopic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative complications
- Bleeding (epigastric / testicular vessels) 2. Bowel injury 3. Peritoneal tear
Measured: during surgical procedure
Postoperative complications
- Seroma 2.Urinary Retention 3. Wound infection
Measured: upto 6 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Sep 2017
- Primary completion20 May 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhawani Khanal, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107986
- Sponsor's protocol ID
- IRC/1217/018
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Laparoscopic Repair in Complicated Groin Hernia: a Single Institutional Based Cohort Study in Nepal
- ClinicalTrials.gov ID
- NCT05107986
- Acronym / sponsor ID
- IRC/1217/018
- Conditions
- Inguinal Hernia
- Keywords
- Complicated groin hernia, Totally extra-peritoneal repair, Transabdominal preperitoneal repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 4 Nov 2021 (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.
This study assessed the outcomes of laparoscopic repair in complicated groin hernia. Laparoscopic approach in cases of complicated groin hernia can achieve desirable patient outcomes without major complications, provided good patient selection and expertise. This study provides an insight to the outcomes from the procedure in low resource setting of Nepal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with complicated groin hernia | – | Procedure: laparoscopic repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of complicated groin hernia
Key inclusion criteria (1 listed)
- Patients with age greater than 18 years with diagnosis of complicated groin hernia
Key exclusion criteria (1 listed)
- Patients with features of peritonitis, history of previous abdominal surgery and those unfit for general anesthesia
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 |
|---|---|---|
| laparoscopic repairAll patients of cohort underwent laparoscopic repair. | Procedure or surgery | Patients diagnosed with complicated groin hernia |
Primary outcome
intraoperative complications
Time frame: during surgical procedure
1. Bleeding (epigastric / testicular vessels) 2. Bowel injury 3. Peritoneal tear
Postoperative complications
Time frame: upto 6 months post operatively
1. Seroma 2.Urinary Retention 3. Wound infection
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 4 Nov 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 1 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 4 Nov 2021. 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?
intraoperative complications (time frame: during surgical procedure). 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?
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 4 Nov 2021.