Laparoscopy in Complicated Groin Hernia | NCT05107986

Studies
Laparoscopy in Complicated Groin Hernia

NCT05107986

Sponsor

B.P. Koirala Institute of Health Sciences

Status

Completed

Last Update Posted

Nov 4, 2021Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Inguinal Hernia

Interventions

laparoscopic repair

Countries

Nepal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

May 20, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

Oct 7, 2021

First Submission Date that Met QC Criteria

Oct 23, 2021

First Posted Date

Nov 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2021

Last Update Posted Date

Nov 4, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bhawani Khanal, Asisstant Professor, B.P. Koirala Institute of Health SciencesPrincipal Investigator

Lead Sponsor

B.P. Koirala Institute of Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients diagnosed with complicated groin hernia			Procedure: laparoscopic repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic repair	Procedure	All patients of cohort underwent laparoscopic repair.	Patients diagnosed with complicated groin hernia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with diagnosis of complicated groin hernia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BP Koirala Institute of Health Sciences		Dharān	Koshi	56700	Nepal

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided