NCT03972553

Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques

Completed NA Last updated 4 December 2023

What this trial tests

NA trial testing Sugarbaker technique for repairing parastomal hernia in Parastomal Hernia in 150 participants. Completed in 27 November 2023.

Timeline

25 April 2019

Primary endpoint
27 November 2023

27 November 2023

Quick facts

Lead sponsor	Clayton Petro
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	25 April 2019
Primary completion	27 November 2023
Estimated completion	27 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Sugarbaker technique for repairing parastomal hernia
• Keyhole technique for repairing parastomal hernia

Conditions studied

• Parastomal Hernia — all drugs for Parastomal Hernia →

Sponsor

Clayton Petro

Who can join

18 and older, any sex, with Parastomal Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial.
   Maskal SM, Ellis RC, Fafaj A, Costanzo A, et al · · 2024 · cited 14× · PMID 38865142 · DOI 10.1001/jamasurg.2024.1686
2. Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial.
   Miller BT, Thomas JD, Tu C, Costanzo A, et al · · 2022 · cited 7× · PMID 35379311 · DOI 10.1186/s13063-022-06207-x
3. Characterizing a clinically significant radiographic parastomal hernia recurrence: post hoc analysis of a randomized controlled trial.
   Bennett WC, Maskal SM, Conner AS, Woo KP, et al · · 2025 · PMID 40789771 · DOI 10.1007/s00464-025-11988-8
4. Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial
   Miller BT, Thomas JD, Tu C, Costanzo A, et al · · 2022 · DOI 10.21203/rs.3.rs-970693/v1