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NCT04440514 Clinical Trial

Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

Parastomal Hernia Clinical Trial

— ePauli  

Official title:
Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04440514
Other study ID # 137157
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 2035

Study information
Verified date March 2023
Source Sykehuset Innlandet HF
Contact jan r lambrecht, PhD
Phone 99703962
Email jan@lambrecht.no
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 2035
Est. primary completion date June 2035
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - parastomal hernia with need of repair Exclusion Criteria: - < 18 years

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• endoscopic preperitoneal repair of parastomal hernia
repair of parastomal hernia after the Sugarbaker principle with TAR and preperitoneal mesh reinforcement

Locations
Country Name City State
Norway Sykehuset Innlandet Hospital Trust Brumunddal
Norway Sykehuset Innlandet HF Hamar

Sponsors (1)
Lead Sponsor Collaborator
Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events Per- and post-operative complications 1 month
Secondary Late complications Stoma function, pain, mesh complications 2 years
Secondary Recurrence of hernia Hernia recurrence 2 years
See also
  Status Clinical Trial Phase
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Recruiting NCT04311333 - Endostomal Three-dimensional Ultrasonography for Parastomal Hernia N/A
Not yet recruiting NCT06077318 - Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia
Completed NCT01380860 - Primary Prevention of Peristomial Hernias Via Parietal Prostheses N/A
Completed NCT00908661 - Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia N/A
Recruiting NCT04282473 - Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
Completed NCT03792243 - Outcomes After Parastomal Hernia Repair
Recruiting NCT01955278 - Role of Prosthetic Mesh in Preventing Parastomal Hernias Phase 3
Terminated NCT00641342 - Prevention of Parastomal Hernia by Primary Mesh Insertion Phase 2/Phase 3
Terminated NCT04966065 - Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies
Not yet recruiting NCT04950140 - Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient N/A
Terminated NCT02489175 - Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia N/A
Recruiting NCT03667287 - Stoma Hernia Intraperitoneal Full-Thickness Skin N/A
Completed NCT01722565 - Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection Phase 4
Completed NCT02368873 - the Use of a IPOM Mesh for Prevention of Parastomal Hernia N/A
Completed NCT02233465 - Treating Parastomal Hernia With a Mesh Phase 1/Phase 2
Completed NCT00917995 - Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh Phase 2/Phase 3
Completed NCT01484743 - Risk Factors for Morbidity After Parastomal Hernia Repair
Completed NCT00509054 - Prevention of Parastomal Hernia With a Mesh Phase 4
Completed NCT04187235 - Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia