Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques

November 30, 2023 updated by: Clayton Petro

Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques: A Registry-Based Randomized Controlled Trial

This will be a randomized controlled trial comparing the incidence of radiographic hernia recurrence 2 years after parastomal hernia repair utilizing the retro-muscular Sugarbaker technique compared to the retro-muscular keyhole mesh technique. The primary endpoint will be recurrence at two years. Secondary endpoints will be the incidence of mesh-related complications, all 30-day complication rates, and hospital length of stay. Patients eligible for the study will be 18 years or older with a parastomal hernia that requires open repair retromuscular repair without ostomy reversal as determined by one of five hernia surgeons who will participate in this study at the investigators' institution. All patients will be marked for a new stoma site preoperatively. Patients who have insufficient bowel length suitable for either technique will be excluded intraoperatively. Patients enrolled in the study will be entered in the Americas Hernia Society Quality Collaborative database by the attending surgeon. The database houses patient demographics, medical comorbidities, operative details, and postoperative outcomes - all entered by the attending surgeon.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent estimates approximate that 120,000 ostomies are created yearly, with an overall prevalence greater than 800,000. Parastomal hernia formation is the most common complication thereof, as most reviews acknowledge a rate of 50%, which increases to 75% for patients with a waist circumference >100cm. As patients live longer and rates of obesity climb, the sequelae of parastomal hernias do as well, including difficulty fitting stoma appliances, parastomal skin breakdown, pain, and obstructive episodes - all negatively impacting the patient's quality of life and compelling them to seek repair.

Recent data from the Americas Hernia Society Quality Collaborative (AHSQC) - a quality improvement hernia registry of surgeon-entered patient demographics, operative details, and outcomes - found that only 22% of stomas were reversible at the time of their parastomal hernia operation.[7] So in the vast majority of cases, the surgeon must decide the optimal technique for repair in the presence of a persistent stoma. Decision-making includes open versus laparoscopic approaches, stoma re-siting versus leaving it in situ, use of mesh, and mesh orientation relative to the bowel. The same AHSQC analysis found that mesh is used in 94% of repairs, and almost 80% are repaired open, likely due to the need for repair of a concomitant midline incisional hernia that frequently exists. As a high-volume hernia center, the investigators' preference has been to perform an open retromuscular repair with a transversus abdominis release (TAR) and retromuscular mesh placement, allowing for reinforcement of the midline, stoma, and prior stoma site if the stoma was re-sited. The stoma can be brought through a keyhole incision in the retromuscular mesh. The investigators' hernia recurrence rate at just 13-months mean follow-up was previously found to be 11%. A more recent audit of parastomal hernia repairs among the investigators using the aforementioned "keyhole" technique with a minimum of 1-year follow-up found a 17% rate of radiographic recurrence and 33% "composite" recurrence rate - patients who feel a bulge, regardless of their radiographic results. Recently, Pauli et al. reported the results of a novel technique for parastomal hernia repair at the 2018 International Hernia Congress with exciting early results. The technique is similar to the investigators' approach with a bilateral transversus abdominis release and placement of a retromuscular mesh reinforcement. However, rather than bringing the stoma through a keyhole defect in the mesh, it is draped over the mesh in the retromuscular space akin to a Sugarbaker repair offsetting the defect in the mesh and the fascia. Six surgeons reported their results of 44 patients with a mean follow-up of 10 months, with a 4.5% (n=2) recurrence rate, with no reports of mesh erosion or stoma necrosis. Given the excellent early results of this novel approach, the investigators hypothesize that the retromuscular Sugarbaker technique would dramatically reduce hernia recurrence compared to the traditional keyhole repair.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Center for Abdominal Core Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient is willing and able to give informed consent
  • Patient has one parastomal hernia
  • Patient is willing to undergo mesh-based repair
  • Patient is considered eligible to undergo open retromuscular repair without ostomy reversal
  • The patient can tolerate general anesthesia
  • Repair being performed in an elective situation

Exclusion Criteria:

  • The subject is <18 years of age
  • Patient has more than one stoma
  • The patient is unable to give informed consent
  • Patient is not willing to undergo mesh-based repair due to any reason
  • Patient not eligible for open retromuscular repair without ostomy reversal
  • Patient is unable to tolerate general anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sugarbaker
For the Sugarbaker group, the bowel will be brought through the peritoneum lateral to the edge of the retromuscular mesh and then draped over the mesh before bringing it through the anterior fascia medially.
Procedure: Sugarbaker technique for repairing parastomal hernia
The bowel will be brought through the peritoneum lateral to the edge of the retromuscular mesh and then draped over the mesh before bringing it through the anterior fascia medially.
Other: Keyhole
For the Keyhole group the stoma will be taken down and rematured through a cruciate incision (keyhole)
Procedure: Keyhole technique for repairing parastomal hernia
The bowel will be brought through defects in the posterior rectus sheath or contiguous peritoneum, mesh, and anterior fascia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic hernia recurrence 2 years after parastomal hernia repair
Time Frame: Two years after the last surgery
To compare the incidence of radiographic hernia recurrence 2 years after parastomal hernia repair utilizing a retromuscular Sugarbaker technique compared to the retromuscular keyhole mesh technique.
Two years after the last surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of mesh-related complications
Time Frame: Two years after the last surgery
To compare the incidence of mesh-related complications between the two study groups.
Two years after the last surgery
30-day complication rates
Time Frame: 30 days after the last surgery
To compare all 30-day complication rates for the two study groups.
30 days after the last surgery
Hospital length-of-stay
Time Frame: An average of 1 week after the last surgery
To compare hospital length-of-stay for the two study groups.
An average of 1 week after the last surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clayton Petro

Investigators

  • Principal Investigator: Clayton Petro, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2019

Primary Completion (Actual)

November 27, 2023

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-398

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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