Pain and Quality of Life After Inguinal Hernia Repair: Laparoscopic Versus Open Repair. (QoL-TAPP)

February 27, 2024 updated by: Hospital Clinic of Barcelona

Pain and Quality of Life After Inguinal Hernia Repair. Randomized Study Comparing Laparoscopic TAPP Repair With Open Lichtenstein Repair (QoL-TAPP Study)

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).

Study Overview

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

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

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: 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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

January 20, 2020

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 22, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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