Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques
NCT ID: NCT03972553
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2019-04-25
2023-11-27
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Keyhole
For the Keyhole group the stoma will be taken down and rematured through a cruciate incision (keyhole)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Clayton Petro
OTHER
Responsible Party
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Clayton Petro
Associate Staff
Principal Investigators
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Clayton Petro, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, United States
Countries
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References
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Turnbull GB. Ostomy statistics: the $64,000 question. Ostomy Wound Manage. 2003 Jun;49(6):22-3. No abstract available.
Hotouras A, Murphy J, Thaha M, Chan CL. The persistent challenge of parastomal herniation: a review of the literature and future developments. Colorectal Dis. 2013 May;15(5):e202-14. doi: 10.1111/codi.12156.
Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220.
De Raet J, Delvaux G, Haentjens P, Van Nieuwenhove Y. Waist circumference is an independent risk factor for the development of parastomal hernia after permanent colostomy. Dis Colon Rectum. 2008 Dec;51(12):1806-9. doi: 10.1007/s10350-008-9366-5. Epub 2008 May 16.
Gavigan T, Stewart T, Matthews B, Reinke C. Patients Undergoing Parastomal Hernia Repair Using the Americas Hernia Society Quality Collaborative: A Prospective Cohort Study. J Am Coll Surg. 2018 Oct;227(4):393-403.e1. doi: 10.1016/j.jamcollsurg.2018.07.658. Epub 2018 Aug 4.
Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF. Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12.
Raigani S, Criss CN, Petro CC, Prabhu AS, Novitsky YW, Rosen MJ. Single-center experience with parastomal hernia repair using retromuscular mesh placement. J Gastrointest Surg. 2014 Sep;18(9):1673-7. doi: 10.1007/s11605-014-2575-4. Epub 2014 Jun 19.
Maskal SM, Ellis RC, Fafaj A, Costanzo A, Thomas JD, Prabhu AS, Krpata DM, Beffa LRA, Tu C, Zheng X, Miller BT, Rosen MJ, Petro CC. Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):982-989. doi: 10.1001/jamasurg.2024.1686.
Miller BT, Krpata DM, Petro CC, Beffa LRA, Carbonell AM, Warren JA, Poulose BK, Tu C, Prabhu AS, Rosen MJ. Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial. J Am Coll Surg. 2022 Sep 1;235(3):401-409. doi: 10.1097/XCS.0000000000000275. Epub 2022 Aug 10.
Miller BT, Thomas JD, Tu C, Costanzo A, Beffa LRA, Krpata DM, Prabhu AS, Rosen MJ, Petro CC. Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial. Trials. 2022 Apr 4;23(1):251. doi: 10.1186/s13063-022-06207-x.
Other Identifiers
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19-398
Identifier Type: -
Identifier Source: org_study_id