Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
NCT ID: NCT02669992
Last Updated: 2023-01-26
Study Results
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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RECRUITING
NA
400 participants
INTERVENTIONAL
2015-06-30
2027-12-31
Brief Summary
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1. The choice of anastomotic method - does it influence the postoperative course?
2. The use of a prophylactic mesh when closing the stoma site - will there be less hernias?
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Detailed Description
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All patients will be randomized to stapled or hand-sewn anastomosis. The randomization to mesh or suture closure of the abdominal wall is optional.
The stapled anastomotic technique is performed by the use of a linear staple device and the hand-sewn technique with a running seromuscular monofilament suture.
The stoma site has two options and will be closed either by the use of mesh (lightweight), positioned under the muscle (retromuscular), or just by long-lasting suture. The anterior fascia of the rectus as well as the skin are closed by the use of running monofilament longlasting sutures, the latter in a pursestring procedure.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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Stapled anastomosis
Stapled anastomosis by the use of commercially available linear stapler device
Stapled or Hand-sewn anastomosis
Randomization between stapled or hand-sewn anastomosis
Hand-sewn anastomosis
Hand-sewn by the use of a resorbable monofilament suture
Stapled or Hand-sewn anastomosis
Randomization between stapled or hand-sewn anastomosis
Abdominal wall mesh closure
Closure by the use of a mesh low-weight net device
Mesh or suture stoma site closure
Randomization between suture or Mesh closure of the stoma site
Abdominal wall suture closure
Closure by the use of slowly absorbing monofilament suture
Mesh or suture stoma site closure
Randomization between suture or Mesh closure of the stoma site
Interventions
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Stapled or Hand-sewn anastomosis
Randomization between stapled or hand-sewn anastomosis
Mesh or suture stoma site closure
Randomization between suture or Mesh closure of the stoma site
Eligibility Criteria
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Inclusion Criteria
* loop ileostomy closure is permitted and possible according to clinical practice
Exclusion Criteria
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Responsible Party
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Ulrik Lindforss
Associate professor
Principal Investigators
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Ulrik Lindforss, A.P
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Locations
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Sahlgrenska Universitetssjukhuset, Östra sjukhuset
Gothenburg, , Sweden
Centralsjukhuset Karlstad
Karlstad, , Sweden
Sunderby Sjukhus
Luleå, , Sweden
Lycksele lasarett
Lycksele, , Sweden
Norrtälje sjukhus
Norrtälje, , Sweden
Östersunds sjukhus
Östersund, , Sweden
Skellefteå lasarett
Skellefteå, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Karolinska universitetssjukhuset
Stockholm, , Sweden
Norrlands Universitets Sjukhus
Umeå, , Sweden
Region Gotland
Visby, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Petra wieveg, MD
Role: primary
Claes Erixon
Role: primary
Christoffer Odensten
Role: primary
Rebecka Zacharias
Role: primary
Pär Nordin
Role: primary
Mats Hjortborg
Role: primary
Ylva Falken, MD
Role: primary
Ulrik Lindforss
Role: primary
Ulf Gunnarsson, prof
Role: primary
References
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Gustavsson K, Gunnarsson U, Jestin P. Postoperative complications after closure of a diverting ileostoma--differences according to closure technique. Int J Colorectal Dis. 2012 Jan;27(1):55-8. doi: 10.1007/s00384-011-1287-4. Epub 2011 Aug 16.
Gong J, Guo Z, Li Y, Gu L, Zhu W, Li J, Li N. Stapled vs hand suture closure of loop ileostomy: a meta-analysis. Colorectal Dis. 2013;15(10):e561-8. doi: 10.1111/codi.12388.
Rubio-Perez I, Leon M, Pastor D, Diaz Dominguez J, Cantero R. Increased postoperative complications after protective ileostomy closure delay: An institutional study. World J Gastrointest Surg. 2014 Sep 27;6(9):169-74. doi: 10.4240/wjgs.v6.i9.169.
Akiyoshi T, Fujimoto Y, Konishi T, Kuroyanagi H, Ueno M, Oya M, Yamaguchi T. Complications of loop ileostomy closure in patients with rectal tumor. World J Surg. 2010 Aug;34(8):1937-42. doi: 10.1007/s00268-010-0547-8.
Chude GG, Rayate NV, Patris V, Koshariya M, Jagad R, Kawamoto J, Lygidakis NJ. Defunctioning loop ileostomy with low anterior resection for distal rectal cancer: should we make an ileostomy as a routine procedure? A prospective randomized study. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1562-7.
Loffler T, Rossion I, Bruckner T, Diener MK, Koch M, von Frankenberg M, Pochhammer J, Thomusch O, Kijak T, Simon T, Mihaljevic AL, Kruger M, Stein E, Prechtl G, Hodina R, Michal W, Strunk R, Henkel K, Bunse J, Jaschke G, Politt D, Heistermann HP, Fusser M, Lange C, Stamm A, Vosschulte A, Holzer R, Partecke LI, Burdzik E, Hug HM, Luntz SP, Kieser M, Buchler MW, Weitz J; HASTA Trial Group. HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040). Ann Surg. 2012 Nov;256(5):828-35; discussion 835-6. doi: 10.1097/SLA.0b013e318272df97.
Other Identifiers
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2015/321-31/1
Identifier Type: -
Identifier Source: org_study_id
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