Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation

June 21, 2023 updated by: Ajita Prabhu, MD, The Cleveland Clinic

Two-armed Single Blinded Non-inferiority Registry Based Randomized Control Trial Comparing Transfascial Sutures for Mesh Fixation to No Mesh Fixation for Open Retromuscular Repairs

This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. The primary outcome of interest is recurrence measured one year postoperatively as per standard of care at Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI). Study population will include all adult patients (18 years or older) undergoing elective open ventral hernia repair of a clean (Wound class I) defect, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included

Study Overview

Detailed Description

The techniques of mesh fixation in open incisional hernia repair is an active area of discussion and debate. When first described, the posterior component separation with the transversus abdominis muscle release involved placing the mesh in the retromuscular space, and fixating it circumferentially with transfascial sutures. These sutures penetrate the entire length of the abdominal wall and can be a significant source of pain. This study aims to evaluate the effect of using no fixation on recurrence rates, compared to the standard of care of using transfacial sutures. The investigators hypothesize that recurrences rates for patients who receive no fixation will be non-inferior to those receiving transfascial sutures.

This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. This will be a two-arm trial with intervention 1: intervention 2 and control allocation ratio of 1:1. The Americas Hernia Society Quality Collaborative (AHSQC) will serve as the platform for data collection. The AHSQC is a multicenter, nationwide quality improvement effort with the mission of improving the quality of hernia care. Data points not recorded in the AHSQC will be collected by a trained research coordination or research fellow and uploaded into a Research Electronic Data Capture (RedCAP®) database hosted at the Cleveland Clinic

Study population will include all adult patients (≥ 18 years) undergoing elective open ventral hernia repair, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included. Exclusion criteria include patients unable to give consent, vulnerable populations, parastomal hernias, hernia width measuring more than 20cm intraoperatively, patients planned for minimally invasive approaches or open repairs with mesh placed in a position other than retromuscular, or those who were not able to undergo successful retromuscular mesh placement. Finally, open repairs performed through a different incision than the standard midline approach will also be considered exclusion criteria, as well as the inability to close the midline fascia.

Study Interventions:

  • Intervention 1 (Control): Mesh will be placed in the retromuscular space, with wide overlap on all sides. Full thickness transfascial sutures will be placed circumferentially to secure the mesh using slowly absorbable no. 1 sutures. A total of six transfascial sutures will be placed universally for all patients with additional sutures allowed according to each surgeon's discretion. Additional bone or ligament sutures for mesh fixation will be allowed according to each surgeon's discretion.
  • Intervention 2: Mesh will be placed in the retromuscular space, with wide overlap on all sides. No fixation method will be used. Bone or ligament sutures for mesh fixation will not be allowed.

Specific Aims:

  • Aim 1: To investigate the non-inferiority of recurrence rates in patients receiving no fixation for a mesh placed in retromuscular position compared to those receiving circumferential transfascial suture fixation. Either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI) will be used to measure recurrence at one-year follow up.
  • Aim 2: To determine if no mesh fixation results in less pain in the immediate postoperative period, measured by the Numeric Pain Rating Scale (NRS-11).
  • Aim 3: To determine if no mesh fixation results in less pain on 30 day follow up, measured by using the Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey
  • Aim 4: To determine if in-hospital intravenous and oral opioid consumption will differ between those who received transfascial sutures and those who did not receive any fixation.
  • Aim 5: To determine if length of stay will differ between those who received transfascial sutures and those who did not receive any fixation.

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Center for Abdominal Core Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing elective open ventral hernia repair, where the midline fascia can be approximated and mesh will be placed in the retromuscular position
  • A midline approach to hernia repair
  • Hernia widths equal to or less than 20cm measured intraoperatively

Exclusion Criteria:

  • Patients unable to give consent and vulnerable populations.
  • Parastomal hernias
  • Hernia width measuring more than 20cm intraoperatively
  • Patients planned for minimally invasive approaches or open repairs with mesh placed in a position other than retromuscular, or those who were not able to undergo successful retromuscular mesh placement.
  • Open repairs performed through a different incision than the standard midline approach
  • Inability to close the midline fascia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transfascial sutures for mesh fixation
Mesh will be placed in the retromuscular space, with wide overlap on all sides. Full thickness transfascial sutures will be placed circumferentially to secure the mesh using slowly absorbable no. 1 sutures. A total of at least six transfascial sutures will be placed universally for all patients with additional sutures allowed according to each surgeon's discretion. Additional bone or ligament sutures for mesh fixation will be allowed according to each surgeon's discretion.
Sutures that pass through the full thickness of the abdominal wall, which are used routinely for mesh fixation
No Intervention: No mesh fixation
Mesh will be placed in the retromuscular space, with wide overlap on all sides. No fixation method will be used. Bone or ligament sutures for mesh fixation will not be allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: One year
primary outcome of interest is recurrence measured one year postoperatively as per standard of care at the Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI), either during a physical or a virtual clinic visit and/or using the telephone. The VHRI is a validated patient reported outcomes tool, a three-question survey that can be administered directly to patients without clinical interaction.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: Baseline and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.
Pain scores will be measured by Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey. The PROMIS pain intensity 3a survery is a National Institute of Health-developed validated tool, which focuses on PROs of pain characteristics.
Baseline and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.
Post-operative pain
Time Frame: Baseline, first 7 days post-operatively, and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.
Pain scores will be measured using the Numeric Pain Rating Scale (NRS-11). The NRS-11 is Likert scale where the patient mark their current pain on scale from 1 to 10.
Baseline, first 7 days post-operatively, and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.
Daily opioid requirements
Time Frame: first 7 days of the post-operative period
Opioid requirements will be assessed by measuring the cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations. The total dose of opioid consumption will be converted to morphine equivalence.
first 7 days of the post-operative period
Length of stay
Time Frame: From date of admission to hospital until the date of discharge from hospital, assessed up to 60 weeks
Length of in-hospital stay will be measured
From date of admission to hospital until the date of discharge from hospital, assessed up to 60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ajita S Prabhu, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2019

Primary Completion (Actual)

December 18, 2022

Study Completion (Actual)

December 18, 2022

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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