Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques

NCT03972553 | Completed

• 1 other identifier: 19-398
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parastomal Hernia

Keywords

Sugarbaker; keyhole; Open parastomal hernia repair

Outcome Measures

Primary Outcomes (1)

• Radiographic hernia recurrence 2 years after parastomal hernia repair

  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 Outcomes (3)

• Incidence of mesh-related complications

  Two years after the last surgery

• 30-day complication rates

  30 days after the last surgery

• Hospital length-of-stay

  An average of 1 week after the last surgery

Study Arms (2)

Sugarbaker

OTHER

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

Keyhole

OTHER

For the Keyhole group the stoma will be taken down and rematured through a cruciate incision (keyhole)

Procedure: Keyhole technique for repairing parastomal hernia

Interventions

Sugarbaker technique for repairing parastomal hernia PROCEDURE

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

Keyhole technique for repairing parastomal hernia PROCEDURE

The bowel will be brought through defects in the posterior rectus sheath or contiguous peritoneum, mesh, and anterior fascia.

Keyhole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clayton Petro: lead

Study Sites (1)

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, 44195, United States

Location

Related Publications (10)

• Turnbull GB. Ostomy statistics: the $64,000 question. Ostomy Wound Manage. 2003 Jun;49(6):22-3. No abstract available.

  PMID: 12874481 BACKGROUND

• 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.

  PMID: 23374759 BACKGROUND

• Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220.

  PMID: 12854101 BACKGROUND

• 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.

  PMID: 18483825 BACKGROUND

• 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.

  PMID: 30081081 BACKGROUND

• 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.

  PMID: 24238119 BACKGROUND

• 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.

  PMID: 24944155 BACKGROUND

• 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.

  PMID: 38865142 DERIVED

• 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.

  PMID: 35588504 DERIVED

• 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.

  PMID: 35379311 DERIVED

Study Officials

• Clayton Petro, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Staff

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 3, 2019
• Study Start: April 25, 2019
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

US (1)