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

NCT03938688 | Completed DMC

• 1 other identifier: 19-333
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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

Conditions

Ventral Hernia; Incisional Hernia

Keywords

ventral hernia repair; mesh; pain; incisional hernia

Outcome Measures

Primary Outcomes (1)

• Recurrence

  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 Outcomes (4)

• Post-operative pain

  Baseline and 30 day follow up. The 30-day follow up period will extend from 15 - 45 days postoperatively.

• Post-operative pain

  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

  first 7 days of the post-operative period

• Length of stay

  From date of admission to hospital until the date of discharge from hospital, assessed up to 60 weeks

Study Arms (2)

Transfascial sutures for mesh fixation

OTHER

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.

Procedure: Mesh placement with Transfascial Sutures

No mesh fixation

NO INTERVENTION

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.

Interventions

Mesh placement with Transfascial Sutures PROCEDURE

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

Transfascial sutures for mesh fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 37342018 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia; Pain

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ajita S Prabhu

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 6, 2019
• Study Start: October 21, 2019
• Primary Completion: December 18, 2022
• Study Completion: December 18, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)