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

NCT ID: NCT03938688

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2022-12-18

Brief Summary

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

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.

Conditions

Ventral Hernia; Incisional Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Mesh placement with Transfascial Sutures

Intervention Type: PROCEDURE

Sutures that pass through the full thickness of the abdominal wall, which are used routinely for mesh fixation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mesh placement with Transfascial Sutures

Sutures that pass through the full thickness of the abdominal wall, which are used routinely for mesh fixation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ajita Prabhu, MD

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajita S Prabhu

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, United States

Countries

United States

References

Ellis RC, Petro CC, Krpata DM, Beffa LRA, Miller BT, Montelione KC, Maskal SM, Tu C, Huang LC, Lau B, Fafaj A, Rosenblatt S, Rosen MJ, Prabhu AS. Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs: A Randomized Clinical Trial. JAMA Surg. 2023 Aug 1;158(8):789-795. doi: 10.1001/jamasurg.2023.1786.

Reference Type: DERIVED

PMID: 37342018 (View on PubMed)

Other Identifiers

19-333

Identifier Type: -

Identifier Source: org_study_id