- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02788812
QOL in Incarcerated Inguinal Hernias: TAPP Vs Open Repair
May 28, 2016 updated by: Siow Sze Li, Sarawak General Hospital
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
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Open modified Lichtenstein repair
|
Open Lichtenstein Hernioplasty
|
Active Comparator: Laparoscopic TAPP inguinal hernia repair
|
Laparoscopic TAPP Hernioplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life scores as measured by Carolinas Comfort Scale
Time Frame: 12 months
|
Carolina Comfort Scale during the duration of follow-up
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operating Time in Minutes
Time Frame: 12 months
|
Comparing the duration of operation between open and laparoscopic surgeries.
|
12 months
|
Duration of Hospitalization in Days
Time Frame: 12 months
|
Comparing the duration of post operative stay between open and laparoscopic surgeries.
|
12 months
|
Recurrence of Hernia after Operation
Time Frame: 12 monthts
|
Comparing the recurrences between open and laparoscopic surgeries.
|
12 monthts
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2016
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
May 21, 2016
First Submitted That Met QC Criteria
May 28, 2016
First Posted (Estimate)
June 2, 2016
Study Record Updates
Last Update Posted (Estimate)
June 2, 2016
Last Update Submitted That Met QC Criteria
May 28, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMRR-16-453-29942
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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