Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis (WOLAP)
Primary Purpose
Inguinal Hernia
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TAPP
TEP
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Woman, Inguinal Hernia, TAPP, TEP, Outpatient Surgery, Ambulatory Surgery
Eligibility Criteria
Inclusion Criteria:
- Inguinofemoral hernia, EHS (European Hernia Society) classification.
- Patient over 18 years old.
- Signed informed consent form.
- Female
- Meeting of outpatient discharge criteria, determined by Aldrete´s test
Exclusion Criteria:
- Loss of domain.
- Abdominal skin grafts.
- Previous preperitoneal (open or laparoscopic) prosthetic mesh.
- Incarcerated hernia.
- Previous complications such as infection, fistulae…
- Not candidate for ambulatory surgery
- Pregnancy or desire for pregnancy in the first postoperative year
Sites / Locations
- Virgen del Rocío University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TAPP (Trans Abdominal PrePeritoneal)
TEP (Totally Extra Peritoneal)
Arm Description
Trans Abdominal PrePeritoneal approach to inguinal hernia repair
Totally Extra Peritoneal approach to inguinal hernia repair
Outcomes
Primary Outcome Measures
Post operative pain
Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)
Recurrence
Recurrence of inguinal hernia in the one-year follow-up
Complications
Postoperative complications including wound complications (seroma, haematoma, infection), gastrointestinal complications (ileus, fistula), urological complications (acute retention, haematuria) and hernia complications (recurrence, chronic groin pain) will be reported. Occurrence of major complications will be registered, including intestinal injury, major vascular lesion, bleeding over 500cc and peritonitis.
Secondary Outcome Measures
Operating time
Operating time from first incision to closure
Hospital stay
length of hospital stay will be measured in hours between the end of the surgery and the time of discharge.
Full Information
NCT ID
NCT04114344
First Posted
September 12, 2019
Last Updated
July 26, 2022
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
1. Study Identification
Unique Protocol Identification Number
NCT04114344
Brief Title
Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis
Acronym
WOLAP
Official Title
Randomized Clinical Trial to Compare TAPP vs TEP Approach for Women's Inguinal Hernia on an Outpatient Basis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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
Open prospective randomised clinical trial enrolling women who suffer from inguinal or femoral hernia, to evaluate if TEP approach is superior to TAPP concerning postoperative development, principally postoperative pain, with no increase of recurrent hernia at the one-year follow-up visit.
Detailed Description
Randomised phase IV clinical trial enrolling women suffering from inguinal hernia in Virgen del Rocío University Hospital influence area, from March 2019 to March 2021.
The aim of the study is to conclusively stablish whether there is real and significant benefit in using TEP approach over TAPP, in an outpatient basis, concerning postoperative evolution. Secondary objectives are the assessment of postoperative pain, using VAS (visual analogic scale), of both techniques, and evaluation of hernia recurrence during the first postoperative year The individuals will be assigned to each group according to simple random sampling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Woman, Inguinal Hernia, TAPP, TEP, Outpatient Surgery, Ambulatory Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAPP (Trans Abdominal PrePeritoneal)
Arm Type
Active Comparator
Arm Description
Trans Abdominal PrePeritoneal approach to inguinal hernia repair
Arm Title
TEP (Totally Extra Peritoneal)
Arm Type
Experimental
Arm Description
Totally Extra Peritoneal approach to inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
TAPP
Intervention Description
Trans Abdominal Pre Peritoneal approach
Intervention Type
Procedure
Intervention Name(s)
TEP
Intervention Description
Total Extra Peritoneal approach
Primary Outcome Measure Information:
Title
Post operative pain
Description
Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)
Time Frame
24 hours
Title
Recurrence
Description
Recurrence of inguinal hernia in the one-year follow-up
Time Frame
One year
Title
Complications
Description
Postoperative complications including wound complications (seroma, haematoma, infection), gastrointestinal complications (ileus, fistula), urological complications (acute retention, haematuria) and hernia complications (recurrence, chronic groin pain) will be reported. Occurrence of major complications will be registered, including intestinal injury, major vascular lesion, bleeding over 500cc and peritonitis.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Operating time
Description
Operating time from first incision to closure
Time Frame
180 minutes
Title
Hospital stay
Description
length of hospital stay will be measured in hours between the end of the surgery and the time of discharge.
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inguinofemoral hernia, EHS (European Hernia Society) classification.
Patient over 18 years old.
Signed informed consent form.
Female
Meeting of outpatient discharge criteria, determined by Aldrete´s test
Exclusion Criteria:
Loss of domain.
Abdominal skin grafts.
Previous preperitoneal (open or laparoscopic) prosthetic mesh.
Incarcerated hernia.
Previous complications such as infection, fistulae…
Not candidate for ambulatory surgery
Pregnancy or desire for pregnancy in the first postoperative year
Facility Information:
Facility Name
Virgen del Rocío University Hospital
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis
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