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

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938688
• Other study ID #: 19-333
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: December 18, 2022

Study information

• Verified date: June 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 18, 2022
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Hernia

Intervention

Procedure:
• Mesh placement with Transfascial Sutures
Sutures that pass through the full thickness of the abdominal wall, which are used routinely for mesh fixation

Locations

Country	Name	City	State
United States	Cleveland Clinic Center for Abdominal Core Health	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative pain	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.
Secondary	Post-operative pain	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.
Secondary	Daily opioid requirements	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
Secondary	Length of stay	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