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

Sponsor

Hospital Plató (Other)

Overall Status

Recruiting

CT.gov ID

NCT04211142

Collaborator

(none)

216

Enrollment

Location

Arms

48.4

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal	Procedure: Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair) Procedure: Open Inguinal Hernia Repair (Lichtenstein repair)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 20, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopic repair Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)	Procedure: Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair) Laparoscopic inguinal hernia repair
Active Comparator: Open repair Open Inguinal Hernia Repair (Lichtenstein repair)	Procedure: Open Inguinal Hernia Repair (Lichtenstein repair) Open Inguinal Hernia Repair

Arm

Intervention/Treatment

Active Comparator: Laparoscopic repair

Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)

Procedure: Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)

Laparoscopic inguinal hernia repair

Active Comparator: Open repair

Open Inguinal Hernia Repair (Lichtenstein repair)

Procedure: Open Inguinal Hernia Repair (Lichtenstein repair)

Open Inguinal Hernia Repair

Outcome Measures

Primary Outcome Measures

Chronic pain [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.

Secondary Outcome Measures

Restrictions of activities [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.
Cosmetic discomfort [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.
Duration of surgery [Surgery]
Time from start of incision to skin closure
Rate of postoperative complications [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.
Early recurrences [1-year]
Clinical recurrence or those confirmed by ultrasound examination