Pain and Quality of Life After Inguinal Hernia Repair: Laparoscopic Versus Open Repair.

NCT ID: NCT04211142

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2025-08-01

Brief Summary

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).

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).

Conditions

Hernia, Inguinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic repair

Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)

Group Type: ACTIVE_COMPARATOR

Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)

Intervention Type: PROCEDURE

Laparoscopic inguinal hernia repair

Open repair

Open Inguinal Hernia Repair (Lichtenstein repair)

Group Type: ACTIVE_COMPARATOR

Open Inguinal Hernia Repair (Lichtenstein repair)

Intervention Type: PROCEDURE

Open Inguinal Hernia Repair

Interventions

Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)

Laparoscopic inguinal hernia repair

Intervention Type: PROCEDURE

Open Inguinal Hernia Repair (Lichtenstein repair)

Open Inguinal Hernia Repair

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvador Guillaumes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Nils Jimmy Hidalgo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Irene Bachero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clínic

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Salvador Guillaumes, MD, PhD

Role: CONTACT

guillaumes@clinic.cat

+ 34 687 79 54 58

Irene Bachero, MD

Role: CONTACT

ibachero@clinic.cat

+34 627 31 59 56

Facility Contacts

Irene Bachero, MD

Role: primary

ibachero@clinic.cat

References

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.

Reference Type: BACKGROUND

PMID: 28218406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27316825 (View on PubMed)

Other Identifiers

QoL-TAPP

Identifier Type: -

Identifier Source: org_study_id