Back to resultsLength of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
hospital stay
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
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
Sites / Locations
- Khyber Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
laparoscopic trans abdominal preperitoneal repair
open mesh repair of inguinal hernia
Arm Description
length of hospital stay
length of hospital stay
Outcomes
Primary Outcome Measures
Duration of hospitals stay
hospital stay in hours after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT05159232
First Posted
November 30, 2021
Last Updated
December 13, 2021
Sponsor
Memon Medical Institute
Collaborators
Khyber Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05159232
Brief Title
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial
Official Title
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memon Medical Institute
Collaborators
Khyber Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non-probability consecutive sampling
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic trans abdominal preperitoneal repair
Arm Type
Active Comparator
Arm Description
length of hospital stay
Arm Title
open mesh repair of inguinal hernia
Arm Type
Active Comparator
Arm Description
length of hospital stay
Intervention Type
Procedure
Intervention Name(s)
hospital stay
Intervention Description
hospital stay in in inguinal hernia repair
Primary Outcome Measure Information:
Title
Duration of hospitals stay
Description
hospital stay in hours after surgery
Time Frame
1-2 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
all male patients
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salma khan, FCPS
Organizational Affiliation
rehman Medical Institute hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khyber Teaching Hospital
City
Peshawar
State/Province
KPK
ZIP/Postal Code
250000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial
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