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Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic preperitoneal repair of parastomal hernia | Procedure | repair of parastomal hernia after the Sugarbaker principle with TAR and preperitoneal mesh reinforcement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Per- and post-operative complications | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Late complications | Stoma function, pain, mesh complications | 2 years |
| Recurrence of hernia | Hernia recurrence | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with permanent ostomy and parastomal hernia in need of repair
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jan r lambrecht, PhD | Contact | 99703962 | jan@lambrecht.no |
| Name | Affiliation | Role |
|---|---|---|
| jan r lambrecht, PhD | Sykehuset Innlandet Hospital Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sykehuset Innlandet Hospital Trust | Enrolling by invitation | Brumunddal | 2380 | Norway | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30081081 | 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. | |
| 29204515 | 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. |
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No sharing
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2020 | Feb 9, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2020 | Feb 9, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| Sykehuset Innlandet HF |
| Recruiting |
| Hamar |
| Norway |
|
| 22418006 | 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. |
| 26229409 | 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. |
| 27023876 | 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. |
| 26818302 | 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. |
| 28840354 | 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. |
| 29134456 | 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. |
| 29974283 | 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. |
| 32495518 | 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. |
| 32152808 | 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. |