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

NCT04150796 | Completed

• 1 other identifier: 19-1288
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. The investigators 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.

Conditions

Ventral Hernia; Umbilical Hernia; Epigastric Hernia

Keywords

Hernia Repair; Minimally-invasive surgery; General surgery

Outcome Measures

Primary Outcomes (1)

• Pain on 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.

  postoperative day 1

Secondary Outcomes (7)

• 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.

  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)

• Postoperative narcotic requirements

  at 30-day (15-45 day) follow-up

• Direct costs

  index surgical encounter

• Hernia recurrence rates

  1 year (9-15 month) follow-up

• Intraoperative Surgeon Workload

  index surgery

Study Arms (2)

Enhanced-view Totally Extraperitoneal (eTEP) Hernia Repair

EXPERIMENTAL

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

Intraperitoneal Onlay Mesh (IPOM) Hernia Repair

ACTIVE COMPARATOR

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

Interventions

Ventral Hernia Repair PROCEDURE

Participants will undergo robotic ventral hernia repair according to the assigned treatment arm.

Enhanced-view Totally Extraperitoneal (eTEP) Hernia Repair; Intraperitoneal Onlay Mesh (IPOM) Hernia Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Petro CC, Maskal SM, Renton DB, Yunis JP, Meara MP, Diaz K, Wilber M, McKenzie K, Tu C, Phillips SE, Miller BT, Beffa LR, Rosen MJ, Prabhu AS. Robotic Enhanced-View Totally Extraperitoneal vs Intraperitoneal Onlay Mesh Evaluation: 1-Year Exploratory Outcomes of the REVEAL Randomized Clinical Trial. J Am Coll Surg. 2023 Oct 1;237(4):614-620. doi: 10.1097/XCS.0000000000000784. Epub 2023 Jun 13.

  PMID: 37310015 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Hernia, Umbilical

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clayton C Petro, MD

  Assistant Professor of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: November 4, 2019
• Primary Completion: November 30, 2021
• Study Completion: October 31, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)