Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT03904888

Recruitment Status : Recruiting

First Posted : April 5, 2019

Last Update Posted : March 8, 2023

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Sponsor:

Information provided by (Responsible Party):

Filip Muysoms, Algemeen Ziekenhuis Maria Middelares

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Inguinal Hernia	Procedure: r-TAPP Procedure: l-TAPP Procedure: local anesthetics	Not Applicable

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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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Diagnostic
Official Title:	Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair
Actual Study Start Date :	September 23, 2019
Estimated Primary Completion Date :	December 2023
Estimated Study Completion Date :	December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

change in PADSS score [ Time Frame: change of Baseline PADSS score up to 24h after surgery or unitl score is ≥ 9 ]
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.

Secondary Outcome Measures :

Recurrence rate [ Time Frame: at 12 month ]
Recurrence rate will be assessed at 12 months post-operatively
Quality of Life assessment: EuraHS Quality of Life questionnaire [ Time Frame: 1 month and 12 months post-operatively ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904888

Contacts

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Contact: Filip Muysoms, MD,PhD	+32477325710	filip.muysoms@gmail.com
Contact: Rita Baumgartner, MSc	0494845897	rita.baumgartner@azmmsj.be

Locations

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

Sponsors and Collaborators

Algemeen Ziekenhuis Maria Middelares

Investigators

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

More Information

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Responsible Party:	Filip Muysoms, Head of Surgery Department, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier:	NCT03904888
Other Study ID Numbers:	Coraline Study
First Posted:	April 5, 2019 Key Record Dates
Last Update Posted:	March 8, 2023
Last Verified:	March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Hernia Hernia, Inguinal Pathological Conditions, Anatomical Hernia, Abdominal Anesthetics	Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

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