Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?

Rectal Neoplasm Clinical Trial

— LISTO  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02669992
• Other study ID #: 2015/321-31/1
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2027

Study information

• Verified date: January 2023
• Source: Karolinska University Hospital
• Contact: Pontus Gustafsson, MD
• Phone: +46703272152
• Email: pontus.gustafsson[@]gotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasm
• Rectal Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Sweden	Sahlgrenska Universitetssjukhuset, Östra sjukhuset	Goteborg
Sweden	Centralsjukhuset Karlstad	Karlstad
Sweden	Sunderby Sjukhus	Lulea
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	Umea
Sweden	Region Gotland	Visby

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. Erratum In: Ann Surg. 2013 Mar;257(3):577. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with postoperative bowel obstruction	Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray	30 days
Primary	Number of participants with postoperative stoma site hernia	Herni postoperatively on the site of previous stoma detected within 2 years	2 year
Secondary	Number of participants with postoperative complications		30 days
Secondary	Postoperative Hospital stay		30 days