- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04211142
Pain and Quality of Life After Inguinal Hernia Repair: Laparoscopic Versus Open Repair. (QoL-TAPP)
Pain and Quality of Life After Inguinal Hernia Repair. Randomized Study Comparing Laparoscopic TAPP Repair With Open Lichtenstein Repair (QoL-TAPP Study)
Study Overview
Status
Conditions
Detailed Description
Inguinal hernia repair is one of the most frequently performed surgical operations. Since the introduction of mesh repair, recurrence rates have fallen dramatically and chronic pain, as a side-effect of surgery, is becoming increasingly important.
Chronic pain is defined as pain or discomfort that lasts for more than 3 months after surgery. The reported incidence of chronic pain varies between 0 and 75 per cent after open mesh repair, and between 0 and 29 per cent after laparoscopic repair. Prospective trials suggest that there is less chronic pain after laparoscopic than open repair.
Although pain is an important parameter determining the Quality of Life (QoL) after a hernia operation, other aspects, like restriction of activities and esthetical outcome, are also of importance.
This investigation will be a double-armed, randomized prospective study designed to compare open (Lichtenstein Technique) versus laparoscopic (TAPP) repair of primary unilateral inguinal hernia.
Chronic pain, restriction of activities and esthetical outcome will be evaluated preoperatively and postoperatively, at 1, 4 and 12 months, using the European Registry for Abdominal Wall Hernias Quality of Life score (EuraHS-QoL score). The EuraHS-QoL score is a validated hernia specific questionnaire with 9 questions that can be scored by the patient in an 11-point scale from 0-10. The EuraHS-QoL questions are divided in 3 domains: "Pain" (range 0-30), "Restriction of activities" (range 0-40), and "Esthetical discomfort" (range 0-20). The total score ranges from 0-90, with the lower scores being the most favourable outcome.
The EuraHS-QoL score can be downloaded in several languages from EuraHS web pages ( http://www.eurahs.eu/EuraHS-QoL-download.php). EuraHS QoL score was previously validated and the results have been already reported in Surgery (Muysoms FE., Surgery. 2016 ;160:1344-1357)
Up to 216 patients will need to be enrolled for this study (n=108/group) and each subject will be followed for up to 12 months after the surgical intervention. The sample size was calculated to explore differences in chronic postoperative pain between the groups, accepting an α risk of 0.05 and a statistical power defined as 90 per cent (β risk = 0.1) in a two-sided test.
The study will be carried out at the Hospital Plató in Barcelona (Spain). Hospital Plató is a district general hospital serving an aggregate population of over 150.000. Hospital surgery department undertakes conventional open and laparoscopic treatment for inguinal hernia on a regular basis.
The hernia repair will be performed in all patients of both arms using the same lightweight polypropylene mesh (Optilene® 60 g/m2 ; B. Braun, Melsungen, Germany): A tailored 7.5 × 15 cm mesh for repairs in the open Lichtenstein arm, and a tailored 15 x 15 cm mesh for all patients in the laparoscopic TAPP arm. To avoid biases, meshes will be fixed in all patients (both groups) by applying liquid drops of n-butyl-2-cyanoacrylate (Histoacryl®; B. Braun Surgical, Rubí, Barcelona, Spain).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Salvador Guillaumes, MD, PhD
- Phone Number: + 34 687 79 54 58
- Email: guillaumes@clinic.cat
Study Contact Backup
- Name: Irene Bachero, MD
- Phone Number: +34 627 31 59 56
- Email: ibachero@clinic.cat
Study Locations
-
-
-
Barcelona, Spain, 08006
- Recruiting
- Hospital Clínic
-
Contact:
- Irene Bachero, MD
- Email: ibachero@clinic.cat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- primary inguinal hernia
- unilateral hernia
Exclusion Criteria:
- bilateral hernia
- recurrent hernia
- incarcerated hernia
- large scrotal hernia
- known femoral hernia
- need for associated procedures
- not able to understand the questionaire
- immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
- chronic renal failure (hemodialysis)
- active infection
- pregnancy
- allergy to polypropylene or cyanoacrylate
- patient's refusal and/or absence of informed consent
Study Plan
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: Laparoscopic repair
Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)
|
Laparoscopic inguinal hernia repair
|
Active Comparator: Open repair
Open Inguinal Hernia Repair (Lichtenstein repair)
|
Open Inguinal Hernia Repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic pain
Time Frame: 1 year
|
Pain scores (0-10) using the European Registry for Abdominal Wall Hernias Quality of Life Instrument (EuraHS Quality of Life questionnaire).
Each question has a scale from 0-10, whereas 0 is considered the best outcome.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restrictions of activities
Time Frame: 1 year
|
Restrictions of activities because of pain or discomfort at the site of the hernia.
Scores (0-10) using the EuraHS Quality of Life questionnaire.
Each question has a scale from 0-10, whereas 0 is considered the best outcome.
|
1 year
|
Cosmetic discomfort
Time Frame: 1 year
|
Cosmetic discomfort with abdomen shape o site of the hernia .
Scores (0-10) using the EuraHS Quality of Life questionnaire.
Each question has a scale from 0-10, whereas 0 is considered the best outcome.
|
1 year
|
Duration of surgery
Time Frame: Surgery
|
Time from start of incision to skin closure
|
Surgery
|
Rate of postoperative complications
Time Frame: 30 days
|
Rate of postoperative complications (i.e., re-admission, urinary retention, symptomatic seroma, surgical-site infection).
The severity of complications will be reported using the Clavien-Dindo classification system.
|
30 days
|
Early recurrences
Time Frame: 1-year
|
Clinical recurrence or those confirmed by ultrasound examination
|
1-year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nils Jimmy Hidalgo, MD, Hospital Clinic of Barcelona
- Principal Investigator: Salvador Guillaumes, MD, PhD, Hospital Clinic of Barcelona
- Principal Investigator: Irene Bachero, MD, Hospital Clinic of Barcelona
Publications and helpful links
General Publications
- Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14.
- Hoyuela C, Juvany M, Carvajal F, Veres A, Troyano D, Trias M, Martrat A, Ardid J, Obiols J, Lopez-Cano M. Randomized clinical trial of mesh fixation with glue or sutures for Lichtenstein hernia repair. Br J Surg. 2017 May;104(6):688-694. doi: 10.1002/bjs.10488. Epub 2017 Feb 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QoL-TAPP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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