Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair

Evaluate the early postoperative course of patients undergoing laparoscopic inguinal hernia repair with either a conventional or a robot assisted approach and with or without the injection of the trocar wounds with a local anesthetic.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: l-TAPP; Procedure: local anesthetics; Procedure: r-TAPP

Detailed Description

Introduction Inguinal hernia is a common disease with a high lifetime risk; 27 % for men and 3% for women. These hernias can be categorized as lateral, medial or femoral according to the classification of the European Hernia Society. The manifestations may vary from an asymptomatic swelling till an incarcerated or strangulated hernia requiring an urgent operation.

The introduction of mesh reinforcement for groin hernia repair has resulted in reducing the rate of recurrences and chronic pain. Moreover, laparoscopic repair techniques made it possible to place the mesh in de pre-peritoneal space by a transperitoneal (TAPP) or pre-peritoneal (TEP) approach. These minimally invasive techniques are not only associated with less chronic pain or numbness, but also with an earlier return to normal activities or work. A favor for one of the two techniques has not yet been proven.

At the Hernia Center Maria Middelares a laparoscopic transabdominal pre-peritoneal (l-TAPP) approach is favored in the majority of adult patients presenting with a groin hernia since more than 20 years. The investigators have adopted a technique using one large pre-peritoneal self-fixating mesh that covers both groins in bilateral laparoscopic repairs. In September 2016 the investigators started to use a robot assisted laparoscopic approach (r-TAPP) for groin hernia repair and built proficiency in this technique with 120 cases operated in the first year of adoption. Barriers to adopting robot assisted groin hernia repair are insufficient availability of the robot, perception of longer operative time, perceived lack of clinical benefit for the patient and increased cost for instrumentation.

In a learning curve study using the daVinci Xi robotic system the investigators have shown that after about 25 cases the skin to skin operating time for r-TAPP equals the skin to skin operating time for l-TAPP. Similarly the overall OR time (patient in and out of the OR) is not increased for r-TAPP compared to l-TAPP if the whole team including nurses and anesthetists have become proficient in robotic assisted surgery (Clinical Trials identifier: NCT0975401).

The investigators standard technique for repair of bilateral groin hernias is to use a self-fixating mesh placed in a pre-peritoneal position with a TAPP approach. The investigator prefers to use one large mesh covering the myopectineal orifice of both groins with a width of 28 cm and a length of 13 cm. The mesh used is a Progrip self-fixating mesh (Medtronic, US), which is a monofilament polyester mesh to which resorbable PLA grips have been added to fixate the mesh to the underlying tissue during the period of mesh ingrowth and incorporation. This technique has been studied in our department in a prospective study focusing on early and one year outcome and has shown favorable results (Clinical Trials identifier: NCT02525666 ).

This study aims to differentiate between the early postoperative recovery after laparoscopic repair of bilateral groin hernias treated either with r-TAPP or with l-TAPP.

A total of 200 male and female patients will be entered in the trial in Maria Middelares Ghent, for which an inclusion period of 24 months is anticipated. Patients will be screened and invited to participate at the outpatient clinic.

Study set-up:

• Based on clinical examination and/or ultrasonography 200 patients will be selected.
• Preoperative, during the outpatients' visit, patients will be asked to sign Informed Consent and to fill out the EuraHS-QoL (Quality of Life score) questionnaire.
• Patients will be randomized, to receive either conventional laparoscopic repair (100 patients) or robot assisted laparoscopic repair (100 patients). Patients will be blinded to the surgical method.
• Furthermore patients will be randomized to either receive local anesthetics (50 patients in each group) or none (50 patients in each group)
• Postoperatively, patients will be invited for clinical follow-up with quality of life evaluations with the EuraHS-QoL score at 1 month and at 12 months.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Filip Muysoms, MD,PhD; Phone Number: +32477325710; Email: filip.muysoms@gmail.com
• Study Contact Backup: Name: Rita Baumgartner, MSc; Phone Number: 0494845897; Email: rita.baumgartner@azmmsj.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Maria Middelares
    • Contact: Filip Muysoms, MD, PhD; Phone Number: 0032-92467400; Email: filip.muysoms@azmmsj.be
    • Contact: Rita Baumgartner, MSc; Phone Number: 0032 - 92467451; Email: rita.baumgartner@azmmsj.be
    • Principal Investigator: Filip Muysoms, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients presenting with a bilateral inguinal hernia planned for a minimal invasive laparoscopic repair

Exclusion Criteria:

• Age below 18 years
• unilateral groin hernia repair
• incarcerated hernias
• open hernia repair
• no informed consent
• pregnant women
• ASA score 4 or more
• patient included in another study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: l-TAPP without local anesthetics; These patients will undergo a laparoscopic surgery without local anaesthetics.	Procedure: l-TAPP; Laporoscopic repair
Other: l-TAPP with local anesthetics; These patients will undergo a laparoscopic surgery with local anaesthetics.	Procedure: l-TAPP; Laporoscopic repair; Procedure: local anesthetics; local anesthetics will be administred
Other: r-TAPP without local anesthetics; These patients will undergo a robot-assisted surgery without local anaesthetics.	Procedure: r-TAPP; Robot-assisted repair
Other: r-TAPP with local anesthetics; These patients will undergo a robot-assisted surgery with local anaesthetics.	Procedure: local anesthetics; local anesthetics will be administred; Procedure: r-TAPP; Robot-assisted repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in PADSS score	Time postoperative for the patient to get fit for discharge as determined by a PADSS score (Post Anesthesia Discharge Scoring System) to reach ≥ 9 (10 is maximum). The score will be taken at 2 hourly intervals after surgery (0 hours,2 hours,4 hours,6 hours,8 hours,10 hours,12 hours,14 hours,16 hours,18 hours,20 hours,22 hours,24 hours) up to 24 hours or unitl score is ≥ 9.	change of Baseline PADSS score up to 24h after surgery or unitl score is ≥ 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	Recurrence rate will be assessed at 12 months post-operatively	at 12 month
Quality of Life assessment: EuraHS Quality of Life questionnaire	Quality of Life assessment using the EuraHS Quality of Life questionnaire. The questionnaire consists of 9 questions. Each question has a scale from 0-10, wherease 0 is considered the best outcome. Total score (max.90) is assessed by summerizing the scale of each question.	1 month and 12 months post-operatively

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Filip Muysoms, MD,PhD, Algemeen Ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: Coraline Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No