Clinical trial NCT02669992: Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
Official title: Loop Ileostomy Closure.Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site in the Abdominal Wall. A Prospective Randomised Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Neoplasm
Keywords: Ileostomy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions:

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?

Detailed description: Postoperative complications after closure of a temporary loop ileostomy after rectal cancer surgery are common. In this study the investigators propose the hypothesis that a stapled anastomotic technique will decrease postoperative small bowel obstruction and a mesh closure of the stoma site in the abdominal wall will decrease hernia formation.

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.

Eligibility criteria: Inclusion Criteria:

* loop ileostomy after rectal cancer surgery
* loop ileostomy closure is permitted and possible according to clinical practice

Exclusion Criteria:

* patient unable to understand written or oral information

Primary outcomes:
measure: Number of participants with postoperative bowel obstruction
timeFrame: 30 days
measure: Number of participants with postoperative stoma site hernia
timeFrame: 2 year
Secondary outcomes:
measure: Number of participants with postoperative complications
timeFrame: 30 days
measure: Postoperative Hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Östra sjukhuset
city: Karlstad
country: Sweden
facility: Centralsjukhuset Karlstad
city: Lulea
country: Sweden
facility: Sunderby Sjukhus
city: Lycksele
country: Sweden
facility: Lycksele lasarett
city: Norrtälje
country: Sweden
facility: Norrtälje sjukhus
city: Skellefteå
country: Sweden
facility: Skellefteå lasarett
city: Stockholm
country: Sweden
facility: Danderyds sjukhus
city: Stockholm
country: Sweden
facility: Karolinska universitetssjukhuset
city: Umea
country: Sweden
facility: Norrlands Universitets Sjukhus
city: Visby
country: Sweden
facility: Region Gotland
city: Östersund
country: Sweden
facility: Östersunds sjukhus
Study officials:
affiliation: Karolinska University Hospital
name: Ulrik Lindforss, A.P
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.