Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04150796 |
| Other study ID # |
19-1288 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 4, 2019 |
| Est. completion date |
October 31, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
The Cleveland Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
This will be a prospective, registry-based, single-blind, randomized controlled trial with a
1:1 allocation ratio. No important changes to the methods are anticipated. This will be a
single-institution study performed at the Cleveland Clinic Foundation in Cleveland, and the
AHSQC will serve as our platform for data collection. All enrollments and surgeries in this
study will take place at Cleveland Clinic Main Campus.
The study will consist of 2 interventions: IPOM or eTEP. Two expert hernia surgeons with
advanced MIS training will enroll patients and perform the operations.
A computer-generated randomization scheme will be built. Randomization will take place on the
Research Electronic Data Capture (REDCap®) database program. Patients will be randomized to
IPOM or eTEP in the operating room after induction of general anesthesia.
The primary outcome measure is early postoperative pain. Secondary outcome measures are cost,
hernia recurrence, and surgeon workload as determined by the NASA Task Load Index (NASA-TLX).
The investigators will also collect outcomes pertaining to abdominal wall-specific quality of
life (measured by Hernia-Related Quality of Life inventory - HerQLes), and 30-day wound
events. No changes to trial outcomes are anticipated, and no interim analyses will be
performed. No stopping guidelines are needed, as both eTEP and IPOM represent current
standards of care for ventral hernia repair.
Subjects will be blinded to the intervention. A similar number of incisions will be present
on the abdomen in similar locations following each intervention, preventing patients from
knowing which intervention they received. The investigators are unable to blind the operating
surgeon to the intervention arm. The investigators are unable to blind the data collector,
the research fellow, to the patients within each intervention arm. However, by utilizing data
largely determined from the patients themselves, who will not be informed of the operation
that they have received until after study completion, The investigators believe that they are
presenting accurate data with limited bias. No subgroup analyses are planned. Patients will
not be included for analysis at any time point for which their data is unavailable. Following
their 1-year visit, patients will be informed regarding the intervention that they received.
Outcomes to be investigated are based on the study hypotheses and are listed below:
Specific Aim #1: To determine if patients with ventral hernias undergoing eTEP experience a
30% decrease in pain scores by postoperative day 1 compared to patients undergoing IPOM.
The primary outcome is early postoperative pain. 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. PROMIS Pain Intensity
3a survey pain scores will be assessed at baseline (at the time of enrollment), at 30 (± 15)
and 365 (± 90) days. NRS-11 scores, often used to measure acute pain, will be obtained in the
post-anesthesia care unit, and on postoperative days 1 (± 1 days), 7 (± 3 days) and 30 (± 15
days). The NRS-11 scores will be obtained either in person while the patients are
hospitalized, or by telephone interview following hospital discharge. Postoperative narcotic
requirements, as recorded on standard of care 30-day follow-up forms, will be collected.
Specific Aim #2: To determine if eTEP is associated with higher direct costs compared to
IPOM.
A secondary outcome is direct cost at the index surgical admission. Cost data will be
obtained from the Cleveland Clinic financial department and will include direct costs. 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. Capital costs, including the
robotic system if used, laparoscopic towers, and non-disposable equipment, will not be
included.
Specific Aim #3: To determine if eTEP is associated with equivalent one-year recurrence rates
compared to IPOM.
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.
Specific Aim #4: To determine if eTEP is associated with increased intraoperative surgeon
workload compared to IPOM.
The investigators 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.
Additional outcomes include abdominal wall-specific quality of life and 30-day wound events.
Abdominal wall-specific quality of life will be determined by the HerQLes questionnaire.
HerQLes is a 12-question hernia-specific survey that has been previously validated in
patients undergoing ventral hernia repair. This will be assessed at baseline, at 30 days (±
15 days) and at 365 days (± 90 days). Wound events are defined 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. This information is already
routinely collected for all patients included in the AHSQC. Additionally, the investigators
will plan to obtain yearly follow-up going forward via quality of life surveys and CT scans
that are standard of care for our group.
