NCT05107986

Brief 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. This study provides an insight to the outcomes from the procedure in low resource setting of Nepal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

October 7, 2021

Last Update Submit

October 23, 2021

Conditions

Inguinal Hernia

Keywords

Complicated groin herniaTotally extra-peritoneal repairTransabdominal preperitoneal repair

Outcome Measures

Primary Outcomes (2)

  • intraoperative complications

    1\. Bleeding (epigastric / testicular vessels) 2. Bowel injury 3. Peritoneal tear

    during surgical procedure

  • Postoperative complications

    1\. Seroma 2.Urinary Retention 3. Wound infection

    upto 6 months post operatively

Study Arms (1)

Patients diagnosed with complicated groin hernia

Procedure: laparoscopic repair

Interventions

laparoscopic repairPROCEDURE

All patients of cohort underwent laparoscopic repair.

Patients diagnosed with complicated groin hernia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of complicated groin hernia

You may qualify if:

  • Patients with age greater than 18 years with diagnosis of complicated groin hernia

You may not qualify if:

  • Patients with features of peritonitis, history of previous abdominal surgery and those unfit for general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BP Koirala Institute of Health Sciences

Dharān, Koshi, 56700, Nepal

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

October 7, 2021

First Posted

November 4, 2021

Study Start

September 1, 2017

Primary Completion

May 20, 2018

Study Completion

September 30, 2018

Last Updated

November 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)