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Randomized Controlled Trial Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias

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ClinicalTrials.gov Identifier: NCT04150796
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Clayton Petro, The Cleveland Clinic

Brief Summary:

Ventral hernias can be repaired using a variety of techniques, with smaller defects often being amenable to minimally invasive surgical (MIS) approaches. For many years, the standard of care MIS approach to ventral hernias has been the laparoscopic intraperitoneal onlay mesh (IPOM) approach, in which a large piece of mesh is placed inside of the abdomen and fixed to the inner abdominal wall using a combination of sutures and/or mechanical tacks. For selected patients, the IPOM approach has demonstrated benefits over open repair, including decreased postoperative length of stay and decreased incidence of surgical site infection.

However, concern regarding long-term outcomes of placing mesh inside the abdomen have spurred the search for alternate approaches to MIS ventral hernia repair. This includes the enhanced-view totally extraperitoneal (eTEP) approach, in which the retromuscular plane is accessed and developed so a large piece of mesh may be implanted outside of the abdominal cavity. The theoretical benefits of this approach are that patients may experience reduced pain because mechanical mesh fixation is not required (as compared to traditional IPOM approaches in which mesh is fixed to the inner abdominal wall) and that mesh is kept outside of the abdominal cavity and away from the viscera, allowing use of less expensive, uncoated mesh and theoretically reducing risk for long-term mesh related complications. While popularity of eTEP has grown, literature published regarding this approach has been mostly retrospective, consists of relatively small series of patients, and suffers from selection bias. For the one prospective study of eTEP published by Radu, et al, there was no comparator arm.

We will conduct a registry-based randomized controlled trial comparing MIS approaches for repair of small to medium-sized ventral hernias, specifically eTEP versus IPOM. This will occur through the Americas Hernia Society Quality Collaborative (AHSQC).

Our hypotheses are multiple: 1) Patients with ventral hernias undergoing eTEP will experience a 30% decrease in pain scores by postoperative day 1 compared to patients undergoing IPOM; 2) eTEP will be associated with higher median direct costs per case versus IPOM; 3) eTEP will be associated with equivalent 1-year hernia recurrence rates versus IPOM; 4) eTEP will be associated with significantly increased intraoperative surgeon workload compared to IPOM.


Condition or disease Intervention/treatment Phase
Ventral Hernia Umbilical Hernia Epigastric Hernia Procedure: Ventral Hernia Repair Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Registry Based, Randomized Controlled Trial Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernia Repair
Estimated Study Start Date : October 25, 2019
Estimated Primary Completion Date : October 25, 2021
Estimated Study Completion Date : October 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Enhanced-view Totally Extraperitoneal (eTEP) Hernia Repair
Initial access into the retromuscular space is achieved using an optical trocar. Insufflation of CO2 is performed under direct visualization. Multiple assistant ports will be placed medial to the semilunar line to continue developing the retromuscular space. The medial insertion of the posterior rectus sheath will be incised to enter the preperitoneal plane and facilitate reduction of hernia contents. The contralateral posterior rectus sheath will be incised and the contralateral retrorectus space will be matured. Suture will be used to close any defect in the hernia sac. The defect will be measured, as will be the retrorectus space. The fascial defect will be closed with suture. Non-barrier coated mesh will be placed in the retrorectus space and flat positioning will be confirmed. Ports will be removed under direct visualization, and the abdomen desufflated. Anterior fascia of any larger ports (8mm or greater) will be closed.
Procedure: Ventral Hernia Repair
Participants will undergo ventral hernia repair according to the assigned treatment arm.

Active Comparator: Intraperitoneal Onlay Mesh (IPOM) Hernia Repair
Access is achieved using an optical trocar. Insufflation of CO2 is performed. Two additional trocars are placed on the left side along the anterior axillary line. If necessary, auxiliary ports may be placed on the right side. When present, hernia contents are reduced using graspers. Adhesions between abdominal contents and the abdominal wall are lysed. The hernia defect is identified and measured internally with a sterile plastic ruler with the abdomen insufflated. Defect closure is performed using nonabsorbable suture. Mesh repair is performed using polypropylene mesh with an absorbable hydrogel barrier. Mesh is chosen to achieve a minimum 3 to 5-centimeter overlap from the edges of the closed defect. Inside the abdomen, the mesh is unrolled and positioning against the anterior abdominal wall is confirmed. Mesh edges are fixed circumferentially with permanent fixation. Ports are removed and the abdomen is desufflated. The anterior fascia of the 12mm port is closed.
Procedure: Ventral Hernia Repair
Participants will undergo ventral hernia repair according to the assigned treatment arm.




Primary Outcome Measures :
  1. Pain on postoperative day 1 [ Time Frame: postoperative day 1 ]
    Pain will be assessed by Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey and the Numeric Pain Rating Scale (NRS-11). The PROMIS pain intensity 3a survey is a National Institutes of Health developed and validated tool that focuses on patient-reported pain characteristics . The NRS-11 is a frequently utilized pain assessment that consists of an easily administered 0 to 10 Likert scale, in which higher scores reflect greater pain intensity.


Secondary Outcome Measures :
  1. Pain in post-anesthesia care unit (PACU), on postoperative day 7, at 30-day (15-45 day) follow-up, and at 1-year (9-15 month) follow-up. [ Time Frame: immediately postoperatively in post-anesthesia care unit (PACU), on postoperative day 7, at 30-day (15-45 day) follow-up, and at 1-year (9-15 month) ]
    Pain will be assessed by Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey and the Numeric Pain Rating Scale (NRS-11). The PROMIS pain intensity 3a survey is a National Institutes of Health developed and validated tool that focuses on patient-reported pain characteristics . The NRS-11 is a frequently utilized pain assessment that consists of an easily administered 0 to 10 Likert scale, in which higher scores reflect greater pain intensity.

  2. Postoperative narcotic requirements [ Time Frame: at 30-day (15-45 day) follow-up ]
    Patient-reported in morphine equivalent doses (MEDs) on standard of care postoperative survey

  3. Direct costs [ Time Frame: index surgical encounter ]
    Direct costs for the index operation will include operating room supply and time, intensive care unit, anesthesia, floor care, laboratory tests, radiology and endoscopy, pharmacy, and in-hospital rehabilitation therapies. The operating room supply direct costs for index surgeries will be further categorized into the following groups: mesh and general supply costs. Indirect costs and total charges will be excluded.

  4. Hernia recurrence rates [ Time Frame: 1 year (9-15 month) follow-up ]
    Hernia recurrence will be assessed with the Ventral Hernia Recurrence Inventory survey (VHRI), radiographically, and with clinical exam at 365 (± 90) days. The VHRI, which uses patient-reported outcomes to detect hernia recurrence, is a validated tool that has been shown to detect ventral hernia recurrence with a sensitivity of 85% and a specificity of 81%. If patients do not follow up in person, the VHRI will be applied over the phone by research fellows or coordinators to determine whether hernia recurrence has occurred. If patients follow up in person and have CT scans available, clinical and radiographic assessments of recurrence will be used to determine whether a recurrence has occurred rather than VHRI.

  5. Intraoperative Surgeon Workload [ Time Frame: index surgery ]
    We plan to measure surgeon workload using the NASA Task Load Index (NASA-TLX) inventory, which is a subjective workload assessment tool for individuals working with human-machine interfaces. This consists of self-reported scales rating an individual's mental demand, physical demand, temporal demand, performance, effort, and frustration. These will be collected from participating surgeons immediately after each operation.

  6. Abdominal wall-specific quality of life [ Time Frame: Baseline, 30-day, 1-year postoperative ]
    Measured using Hernia-related quality of life survey (HerQLes)

  7. Wound events [ Time Frame: at 30(± 15) days and 365 (± 90) days. ]
    as surgical site infection (SSI), surgical site occurrence (SSO) and surgical site occurrences requiring procedural intervention (SSOPI), as defined by the Ventral Hernia Working Group. Wound events will be assessed by a physical exam at 30(± 15) days and 365 (± 90) days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patient
  • Primary ventral or incisional hernia defects
  • Midline defect with an expected hernia width equal to or less than 7 centimeters
  • Elective hernia repair
  • Considered eligible for hernia repair through a minimally-invasive approach
  • Able to tolerate general anesthesia
  • Able to give consent for participation

Exclusion Criteria:

  • Defects greater than 7 centimeters
  • Hernia defects considered to require an open approach
  • Prior mesh placement in the retrorectus space
  • Patients not able to understand and sign a written consent form

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): NCT04150796


Contacts
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Contact: Clayton C Petro, MD 216 444-3501 PETROC@ccf.org
Contact: Samuel J Zolin, MD 216-308-2412 zolins@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clayton C Petro, MD    216-444-3501    PETROC@ccf.org   
Contact: Samuel J Zolin, MD    2163082412    zolins@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Clayton C Petro, MD Assistant Professor of Surgery

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Responsible Party: Clayton Petro, Staff Surgeon, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04150796     History of Changes
Other Study ID Numbers: 19-1288
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
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
Keywords provided by Clayton Petro, The Cleveland Clinic:
Hernia Repair
Minimally-invasive surgery
General surgery
Additional relevant MeSH terms:
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Hernia, Umbilical
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases