Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT05514600 |
Other study ID # |
22-634 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 8, 2022 |
Est. completion date |
May 20, 2023 |
Study information
Verified date |
July 2023 |
Source |
The Cleveland Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.