Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair
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| ClinicalTrials.gov Identifier: NCT03904888 |
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Recruitment Status :
Recruiting
First Posted : April 5, 2019
Last Update Posted : March 8, 2023
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| Tracking Information | |||||||||
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| First Submitted Date ICMJE | March 19, 2019 | ||||||||
| First Posted Date ICMJE | April 5, 2019 | ||||||||
| Last Update Posted Date | March 8, 2023 | ||||||||
| Actual Study Start Date ICMJE | September 23, 2019 | ||||||||
| Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair | ||||||||
| Official Title ICMJE | Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair | ||||||||
| 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. | ||||||||
| 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:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Inguinal Hernia | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2024 | ||||||||
| Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Belgium | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03904888 | ||||||||
| Other Study ID Numbers ICMJE | Coraline Study | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Filip Muysoms, Algemeen Ziekenhuis Maria Middelares | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | Algemeen Ziekenhuis Maria Middelares | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Algemeen Ziekenhuis Maria Middelares | ||||||||
| Verification Date | March 2023 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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