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

Hernia, Inguinal Clinical Trial

— QoL-TAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211142
• Other study ID #: QoL-TAPP
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: August 1, 2025

Study information

• Verified date: February 2024
• Source: Hospital Clinic of Barcelona
• Contact: Salvador Guillaumes, MD, PhD
• Phone: + 34 687 79 54 58
• Email: guillaumes[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)
Laparoscopic inguinal hernia repair
• Open Inguinal Hernia Repair (Lichtenstein repair)
Open Inguinal Hernia Repair

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain	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	Restrictions of activities	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
Secondary	Cosmetic discomfort	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
Secondary	Duration of surgery	Time from start of incision to skin closure	Surgery
Secondary	Rate of postoperative complications	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
Secondary	Early recurrences	Clinical recurrence or those confirmed by ultrasound examination	1-year