Clinical trial NCT05514600: Fascial Defect Closure for Minimally Invasive Parastomal Hernia Repair
Official title: The Impact of Fascial Defect Closure for Minimally Invasive Parastomal Hernia Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parastomal Hernia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Stoma specific quality of life score (1 year)
timeFrame: 1 year
Secondary outcomes:
measure: Stoma specific quality of life score (30 days)
timeFrame: 30 days
measure: Stoma specific quality of life score (2 years)
timeFrame: 2 years
measure: Recurrence
timeFrame: 2 years
measure: Pain Intensity
timeFrame: 2 years
measure: Abdominal Wall Specific Quality of Life
timeFrame: 2 years
measure: Length of stay
timeFrame: 30 days
measure: Ileus
timeFrame: 30 days
measure: Opioid consumption
timeFrame: 30 days
measure: Wound morbidity
timeFrame: 30 days
measure: Decision Regret
timeFrame: 2 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References: