Inguinal HerniaWOLAPNCT04114344
Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis
A study testing TAPP and TEP in people with Inguinal Hernia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- TAPP and TEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Compare TAPP vs TEP Approach for Women's Inguinal Hernia on an Outpatient Basis
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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- TAPP, TEP
- Keywords
- Woman, Inguinal Hernia, TAPP, TEP, Outpatient Surgery, Ambulatory Surgery
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPPProcedure or surgery
Trans Abdominal Pre Peritoneal approach
TEPProcedure or surgery
Total Extra Peritoneal approach
| Study group | Role | What they receive |
|---|---|---|
| TAPP (Trans Abdominal PrePeritoneal) | Active comparator | Trans Abdominal PrePeritoneal approach to inguinal hernia repair Receives: Procedure: TAPP |
| TEP (Totally Extra Peritoneal) | Experimental | Totally Extra Peritoneal approach to inguinal hernia repair Receives: Procedure: TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)
Measured: 24 hours
Recurrence
Recurrence of inguinal hernia in the one-year follow-up
Measured: One year
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.
Measured: One year
Secondary outcomes (2)
Operating time
Operating time from first incision to closure
Measured: 180 minutes
Hospital stay
length of hospital stay will be measured in hours between the end of the surgery and the time of discharge.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 May 2019
- Primary completionOct 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Tinoco González, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114344
- Sponsor's protocol ID
- WO_LAP
- Acronym
- WOLAP
- Status last verified
- Jul 2022
- First submitted
- 12 Sep 2019
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Compare TAPP vs TEP Approach for Women's Inguinal Hernia on an Outpatient Basis
- ClinicalTrials.gov ID
- NCT04114344
- Acronym / sponsor ID
- WOLAP / WO_LAP
- Conditions
- Inguinal Hernia
- Keywords
- Woman, Inguinal Hernia, TAPP, TEP, Outpatient Surgery, Ambulatory Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAPP (Trans Abdominal PrePeritoneal) | Active comparator | Procedure: TAPPTrans Abdominal PrePeritoneal approach to inguinal hernia repair |
| TEP (Totally Extra Peritoneal) | Experimental | Procedure: TEPTotally Extra Peritoneal approach to inguinal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Loss of domain.
- Abdominal skin grafts.
- Previous preperitoneal (open or laparoscopic) prosthetic mesh.
- Incarcerated hernia.
- Previous complications such as infection, fistulae…
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAPPTrans Abdominal Pre Peritoneal approach | Procedure or surgery | TAPP (Trans Abdominal PrePeritoneal) |
| TEPTotal Extra Peritoneal approach | Procedure or surgery | TEP (Totally Extra Peritoneal) |
Primary outcome
Post operative pain
Time frame: 24 hours
Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO)
Recurrence
Time frame: One year
Recurrence of inguinal hernia in the one-year follow-up
Complications
Time frame: One year
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.
2 secondary outcomes
Operating time
Time frame: 180 minutes
Hospital stay
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAPP and TEP in people with Inguinal Hernia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.