Length of Hospital Stay in Laparoscopic Transabdominal Pr... | NCT05159232

Studies
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial

NCT05159232

Sponsor

Memon Medical Institute

Status

Completed

Last Update Posted

Dec 16, 2021Actual

Enrollment

334Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

hospital stay

Countries

Pakistan

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

Dec 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, 2018Actual

Primary Completion Date

Oct 30, 2020Actual

Completion Date

Oct 30, 2020Actual

First Submitted Date

Nov 30, 2021

First Submission Date that Met QC Criteria

Dec 13, 2021

First Posted Date

Dec 16, 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

Dec 13, 2021

Last Update Posted Date

Dec 16, 2021Actual

Name	Class
Khyber Teaching Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To compare the mean length of hospital stay in laparoscopic trans abdominal preperitoneal repair versus open mesh repair in patients undergoing inguinal hernia repair with mesh.

Detailed Description

A total of 334 patients of male gender with Inguinal hernias of any side and ASA score I and II were included in the study. History of Immunosuppression, associated with other abdominal hernias and recurrent hernia were excluded. 167 patients were in Group A or laparoscopic trans abdominal preperitoneal repair group while 167 patients were in Group B or open mesh repair. Data regarding length of hospital stay from both groups was recorded by researcher himself on especially designed proforma.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

334Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopic trans abdominal preperitoneal repair	Active Comparator	length of hospital stay	Procedure: hospital stay
open mesh repair of inguinal hernia	Active Comparator	length of hospital stay	Procedure: hospital stay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hospital stay	Procedure	hospital stay in in inguinal hernia repair	laparoscopic trans abdominal preperitoneal repair open mesh repair of inguinal hernia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of hospitals stay	hospital stay in hours after surgery	1-2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Age 18-60 years
- Inguinal hernias of any side as per operational definition
- ASA score I and II

Exclusion Criteria:

• H/o Immunosuppression
- Associated with other abdominal hernias
- H/o recurrent hernia

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

all male patients

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Salma khan, FCPS	rehman Medical Institute hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Khyber Teaching Hospital		Peshawar	KPK	250000	Pakistan

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

Intervention Browse Module

MeSH Terms

ID	Term
D007902	Length of Stay

Ancestor Terms

ID	Term
D006760	Hospitalization
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided