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Parastomal HerniaePauliNCT04440514

Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

An observational study of Parastomal Hernia, run by Sykehuset Innlandet HF at 2 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Any age
Conditions the study is for
Parastomal Hernia
What is being tested?
endoscopic preperitoneal repair of parastomal hernia
Type of treatment
Surgery or procedure
How many people
150 participants
Where
2 sitesNorway
Study dates
1 Jun 2020to Jun 2035
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with permanent ostomy and parastomal hernia in need of repair

Who may be able to join

  • parastomal hernia with need of repair

Who cannot join

  • < 18 years

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

jan r lambrecht, PhD contact

99703962

jan@lambrecht.no

Norway2 sites, 2 recruiting

  • Sykehuset Innlandet Hospital Trust

    Brumunddal, 2380

    Enrolling by invitation

  • Sykehuset Innlandet HF

    Hamar

    jan r lambrecht, md, phd

    lars martin rekkedal, md

    Recruiting

Other trials in Norway

About this study

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

Read the detailed description

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.

Being tested
endoscopic preperitoneal repair of parastomal hernia
Keywords
hernia, parastomal, robotic, laparoscopic, transversus abdominis release, repair, incisional
Medical subject headings
Hernia, Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopic preperitoneal repair of parastomal herniaProcedure or surgery

    Also called ePauli

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Per- and post-operative complications

    Measured: 1 month

Secondary outcomes (2)

  1. Late complications

    Stoma function, pain, mesh complications

    Measured: 2 years

  2. Recurrence of hernia

    Hernia recurrence

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completionJun 2035 (estimated)
  4. Study completionJun 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04440514
Sponsor's protocol ID
137157
Acronym
ePauli
Status last verified
Mar 2023
First submitted
17 Jun 2020
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No sharing

Publications

  • 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.

    PubMed 30081081

  • 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.

    PubMed 29204515

  • 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.

    PubMed 22418006

  • 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.

    PubMed 26229409

  • 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.

    PubMed 27023876

  • 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.

    PubMed 26818302

  • 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.

    PubMed 28840354

  • 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.

    PubMed 29134456

  • 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.

    PubMed 29974283

  • 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.

    PubMed 32495518

  • 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.

    PubMed 32152808

Questions about this trial

What is this clinical trial studying?

An observational study of Parastomal Hernia, run by Sykehuset Innlandet HF at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jan r lambrecht, PhD (99703962, jan@lambrecht.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04440514, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.

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