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

December 13, 2021 updated by: salma khan, Memon Medical Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 250000
        • Khyber Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparoscopic trans abdominal preperitoneal repair
length of hospital stay
Procedure: hospital stay
hospital stay in in inguinal hernia repair
Active Comparator: open mesh repair of inguinal hernia
length of hospital stay
Procedure: hospital stay
hospital stay in in inguinal hernia repair

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memon Medical Institute

Collaborators

Khyber Teaching Hospital

Investigators

  • Principal Investigator: Salma khan, FCPS, rehman Medical Institute hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IREB#194-SUR-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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