Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

NCT04440514 | Recruiting

• 1 other identifier: 137157
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.

Conditions

Parastomal Hernia

Keywords

hernia; parastomal; robotic; laparoscopic; transversus abdominis release; repair; incisional

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Per- and post-operative complications

  1 month

Secondary Outcomes (2)

• Late complications

  2 years

• Recurrence of hernia

  2 years

Interventions

endoscopic preperitoneal repair of parastomal hernia PROCEDURE

repair of parastomal hernia after the Sugarbaker principle with TAR and preperitoneal mesh reinforcement

Also known as: ePauli

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with permanent ostomy and parastomal hernia in need of repair

You may qualify if:

• parastomal hernia with need of repair

You may not qualify if:

• \< 18 years

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (2)

Sykehuset Innlandet Hospital Trust

Brumunddal, 2380, Norway

ENROLLING BY INVITATION

Sykehuset Innlandet HF

Hamar, Norway

RECRUITING

Related Publications (11)

• 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

• Nasvall P, Rutegard J, Dahlberg M, Gunnarsson U, Strigard K. Parastomal Hernia Repair with Intraperitoneal Mesh. Surg Res Pract. 2017;2017:8597463. doi: 10.1155/2017/8597463. Epub 2017 Oct 24.

  PMID: 29204515 BACKGROUND

• Hansson BM, Slater NJ, van der Velden AS, Groenewoud HM, Buyne OR, de Hingh IH, Bleichrodt RP. Surgical techniques for parastomal hernia repair: a systematic review of the literature. Ann Surg. 2012 Apr;255(4):685-95. doi: 10.1097/SLA.0b013e31824b44b1.

  PMID: 22418006 BACKGROUND

• DeAsis FJ, Lapin B, Gitelis ME, Ujiki MB. Current state of laparoscopic parastomal hernia repair: A meta-analysis. World J Gastroenterol. 2015 Jul 28;21(28):8670-7. doi: 10.3748/wjg.v21.i28.8670.

  PMID: 26229409 BACKGROUND

• Pauli EM, Juza RM, Winder JS. How I do it: novel parastomal herniorrhaphy utilizing transversus abdominis release. Hernia. 2016 Aug;20(4):547-52. doi: 10.1007/s10029-016-1489-3. Epub 2016 Mar 29.

  PMID: 27023876 BACKGROUND

• Jones CM, Winder JS, Potochny JD, Pauli EM. Posterior Component Separation with Transversus Abdominis Release: Technique, Utility, and Outcomes in Complex Abdominal Wall Reconstruction. Plast Reconstr Surg. 2016 Feb;137(2):636-646. doi: 10.1097/01.prs.0000475778.45783.e2.

  PMID: 26818302 BACKGROUND

• Tastaldi L, Haskins IN, Perez AJ, Prabhu AS, Rosenblatt S, Rosen MJ. Single center experience with the modified retromuscular Sugarbaker technique for parastomal hernia repair. Hernia. 2017 Dec;21(6):941-949. doi: 10.1007/s10029-017-1644-5. Epub 2017 Aug 24.

  PMID: 28840354 BACKGROUND

• Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.

  PMID: 29134456 BACKGROUND

• Belyansky I, Reza Zahiri H, Sanford Z, Weltz AS, Park A. Early operative outcomes of endoscopic (eTEP access) robotic-assisted retromuscular abdominal wall hernia repair. Hernia. 2018 Oct;22(5):837-847. doi: 10.1007/s10029-018-1795-z. Epub 2018 Jul 4.

  PMID: 29974283 BACKGROUND

• Imamura K, Takada M, Umemoto K, Furukawa S, Ambo Y, Nakamura F. Laparoscopic parastomal herniorrhaphy utilizing transversus abdominis release and a modified Sugarbaker technique: A case report. Asian J Endosc Surg. 2021 Jan;14(1):106-108. doi: 10.1111/ases.12804. Epub 2020 Jun 3.

  PMID: 32495518 BACKGROUND

• Zolin SJ, Fafaj A, Krpata DM. Transversus abdominis release (TAR): what are the real indications and where is the limit? Hernia. 2020 Apr;24(2):333-340. doi: 10.1007/s10029-020-02150-5. Epub 2020 Mar 9.

  PMID: 32152808 BACKGROUND

MeSH Terms

Conditions

Hernia; Surgical Wound

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• jan r lambrecht, PhD

  Sykehuset Innlandet Hospital Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jan r lambrecht, PhD

CONTACT

99703962; jan@lambrecht.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: June 1, 2020
• Primary Completion (Estimated): June 1, 2035
• Study Completion (Estimated): June 1, 2035
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)