Back to resultsQOL in Incarcerated Inguinal Hernias: TAPP Vs Open Repair
Primary Purpose
Inguinal Hernia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open modified Lichtenstein repair
Laparoscopic TAPP inguinal hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and older
- Both genders
- Unilateral inguinal hernias
- Incarcerated inguinal hernias
- Elective setting
Exclusion Criteria:
- Anaesthesiologists) Grade > 2
- Recurrence
- Inguinal-scrotal hernias
- Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
- Pregnancy
- Refusal for general anaesthesia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Open modified Lichtenstein repair
Laparoscopic TAPP inguinal hernia repair
Arm Description
Outcomes
Primary Outcome Measures
Quality of life scores as measured by Carolinas Comfort Scale
Carolina Comfort Scale during the duration of follow-up
Secondary Outcome Measures
Operating Time in Minutes
Comparing the duration of operation between open and laparoscopic surgeries.
Duration of Hospitalization in Days
Comparing the duration of post operative stay between open and laparoscopic surgeries.
Recurrence of Hernia after Operation
Comparing the recurrences between open and laparoscopic surgeries.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02788812
Brief Title
QOL in Incarcerated Inguinal Hernias: TAPP Vs Open Repair
Official Title
The Comparison of the Quality of Life and Outcomes in Patient's With Incarcerated Inguinal Hernias: Laparoscopic Transabdominal Pre-peritoneal (TAPP) Versus Modified Lichtenstein Hernioplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sarawak General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic transabdominal pre-peritoneal (TAPP) or modified Lichtenstein hernioplasty
Detailed Description
Patients presenting with incarcerated inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open modified Lichtenstein repair
Arm Type
Active Comparator
Arm Title
Laparoscopic TAPP inguinal hernia repair
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Open modified Lichtenstein repair
Intervention Description
Open Lichtenstein Hernioplasty
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic TAPP inguinal hernia repair
Intervention Description
Laparoscopic TAPP Hernioplasty
Primary Outcome Measure Information:
Title
Quality of life scores as measured by Carolinas Comfort Scale
Description
Carolina Comfort Scale during the duration of follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Operating Time in Minutes
Description
Comparing the duration of operation between open and laparoscopic surgeries.
Time Frame
12 months
Title
Duration of Hospitalization in Days
Description
Comparing the duration of post operative stay between open and laparoscopic surgeries.
Time Frame
12 months
Title
Recurrence of Hernia after Operation
Description
Comparing the recurrences between open and laparoscopic surgeries.
Time Frame
12 monthts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age and older
Both genders
Unilateral inguinal hernias
Incarcerated inguinal hernias
Elective setting
Exclusion Criteria:
Anaesthesiologists) Grade > 2
Recurrence
Inguinal-scrotal hernias
Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
Pregnancy
Refusal for general anaesthesia
12. IPD Sharing Statement
Plan to Share IPD
No
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QOL in Incarcerated Inguinal Hernias: TAPP Vs Open Repair
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