Fascial Defect Closure for Minimally Invasive Parastomal Hernia Repair

NCT ID: NCT05514600

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2023-05-20

Brief Summary

Fascial closure was not originally a routine component of minimally invasive parastomal hernia repairs, but several recent advancements have made fascial closure more common in this context. These include barbed self-locking sutures that aid intracorporeal fascial closure under tension, and wristed instrumentation offered by the robotic platform when available. The investigator aims to characterize the clinical significance of closing the fascia adjacent to the stoma during a MIS parastomal hernia repair.

The investigator hypothesizes that fascial closure will not have a significant impact on postoperative stoma specific quality of life but will reduce long-term recurrence.

Detailed Description

This trial will follow the same methodology of data collection employed in previous randomized controlled trials (RCTs) performed by the Cleveland Clinic Center for Abdominal Core Health. The Abdominal Core Health Quality Collaborative (ACHQC) registry will serve as the main platform for data collection. This will be a single-institution study, performed at the Cleveland Clinic Foundation (CCF) hospital in Ohio. Enrollment and surgeries are anticipated to occur at Cleveland Clinic Center for Abdominal Core Health located at Main Campus.

After minimally invasive access and completion of adhesiolysis the surgeon will determine if a minimally invasive intraperitoneal Sugarbaker repair can be achieved. Those patients who cannot be repaired by a minimally invasive intraperitoneal Sugarbaker technique or who convert to an open procedure will be considered screen failures. For those able to be repaired with a minimally invasive intraperitoneal Sugarbaker technique, patients will be randomized to parastomal fascial closure with a running #1 Stratafix symmetric or not. Management of concomitant non-stoma defects that will also be covered with intraperitoneal mesh will be managed at the surgeon's discretion. Surgeons should achieve at least 4cm of mesh overlap from the edge of the parastomal fascial edge before closure. The edge of the mesh can be secured with sutures or tacks at the surgeon's discretion and details will be collected per standard of care in the ACHQC.

Baseline patient demographic information, medical co-morbidities, hernia characteristics, operative details, and 30-day outcomes are already captured within the ACHQC database, allowing for follow-up, and data capture with decreased effort outside of routine care. Baseline patient eligibility criteria will be obtained at initial patient recruitment, and baseline ACHQC questionnaires will be completed following patient consent. Standard of care questionnaires include information on baseline opioid consumption, the PROMIS Pain Intensity instrument, and Hernia Related Quality-of-Life Survey (HerQles). Patients will be required to complete these forms at each clinic visit, or via telephone contact, as this is standard procedure for all patients in our hernia practice. Follow-up will be targeted at 30 +/- 15 days, 1 year ± 4 months, and 2 years ± 6 months with CT scans of the abdomen and pelvis done at the 1 and 2 year time points which is the standard of care for Cleveland Clinic.

Non-standard of care outcome measures, operative time, parastomal defect dimensions (can be separate and distinct in the presence of a concomitant ventral hernia) and randomization will be stored in RedCAP®. Additional tools include the Colostomy Impact Score, which assesses stoma-specific quality of life and will be attained at baseline, 30-days, 1 year, and 2 years. Finally, decision regret using the decision regret scale will be assessed at 30-days, 1 year, and 2 years.

Conditions

Parastomal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fascial closure

This arm will have the parastomal fascial defect closed with a running barbed suture prior to mesh placement.

Group Type: ACTIVE_COMPARATOR

closure of parastomal hernia fascial defect

Intervention Type: PROCEDURE

For subjects randomized to the fascial closure arm, the parastomal defect will be closed using barbed, running suture prior to placement of the mesh.

No fascial closure

This arm will undergo mesh placement +/- fixation without the fascial defect being closed prior.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

closure of parastomal hernia fascial defect

For subjects randomized to the fascial closure arm, the parastomal defect will be closed using barbed, running suture prior to placement of the mesh.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients 18 years or older
• End or loop-end stoma with a parastomal defect - candidate for minimally invasive Sugarbaker repair at the discretion of the staff surgeon.
• Anticipated parastomal fascial defect should not exceed 7cm in any direction
• Patient able to tolerate a minimally invasive repair, the surgeon can achieve minimally invasive access and complete a minimally invasive adhesiolysis.
• Bowel able to be lateralized at least 4cm beyond the edge of the parastomal fascial defect

Exclusion Criteria

• Loop stoma
• Parastomal fascial defect >7cm
• Concomitant ventral defect or complexity of the repair warrants open repair at the discretion of the staff surgeon
• Minimally invasive Sugarbaker repair with intraperitoneal mesh cannot be achieved.

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

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Clayton Petro

MD, FACS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

22-634

Identifier Type: -

Identifier Source: org_study_id