NCT05159232

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

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, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

2.2 years

First QC Date

November 30, 2021

Last Update Submit

December 13, 2021

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Duration of hospitals stay

    hospital stay in hours after surgery

    1-2 days

Study Arms (2)

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

hospital stayPROCEDURE

hospital stay in in inguinal hernia repair

laparoscopic trans abdominal preperitoneal repairopen mesh repair of inguinal hernia

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsall male patients
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 250000, Pakistan

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Length of Stay

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HospitalizationPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Salma khan, FCPS

    rehman Medical Institute hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: non-probability consecutive sampling
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof Surgery

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 16, 2021

Study Start

September 1, 2018

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)