Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

NCT ID: NCT04440514

Last Updated: 2023-03-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2035-06-30

Brief Summary

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

Detailed Description

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Endoscopic trans-abdominal preperitoneal plasty (TAPP) for parastomal hernia employing transversus abdominis release component separation (TAR) and reinforcement with mesh after the Sugarbaker principle, but placing mesh extraabdominally, anteriorly to the transversalis fascia. Laparoscopic and robotic procedures. Repair of concomitant midline hernia with endoscopic enhanced-view Rives-Stoppa technique.

Conditions

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Parastomal Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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endoscopic preperitoneal repair of parastomal hernia

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

Intervention Type PROCEDURE

Other Intervention Names

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ePauli

Eligibility Criteria

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Inclusion Criteria

* parastomal hernia with need of repair

Exclusion Criteria

* \< 18 years
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jan r lambrecht, PhD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Innlandet Hospital Trust

Locations

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Sykehuset Innlandet Hospital Trust

Brumunddal, , Norway

Site Status ENROLLING_BY_INVITATION

Sykehuset Innlandet HF

Hamar, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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jan r lambrecht, PhD

Role: CONTACT

Facility Contacts

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jan r lambrecht, md, phd

Role: primary

lars martin rekkedal, md

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 30081081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29204515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22418006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26229409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27023876 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26818302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28840354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29134456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29974283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32495518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32152808 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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137157

Identifier Type: -

Identifier Source: org_study_id

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