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

Primary Purpose

Rectal Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Stapled or Hand-sewn anastomosis
Mesh or suture stoma site closure
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Neoplasm focused on measuring Ileostomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska Universitetssjukhuset, Östra sjukhusetRecruiting
  • Centralsjukhuset KarlstadRecruiting
  • Sunderby SjukhusRecruiting
  • Lycksele lasarettRecruiting
  • Norrtälje sjukhusRecruiting
  • Skellefteå lasarettRecruiting
  • Danderyds sjukhusRecruiting
  • Karolinska universitetssjukhusetRecruiting
  • Norrlands Universitets SjukhusRecruiting
  • Region GotlandRecruiting
  • Östersunds sjukhusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Stapled anastomosis

Hand-sewn anastomosis

Abdominal wall mesh closure

Abdominal wall suture closure

Arm Description

Stapled anastomosis by the use of commercially available linear stapler device

Hand-sewn by the use of a resorbable monofilament suture

Closure by the use of a mesh low-weight net device

Closure by the use of slowly absorbing monofilament suture

Outcomes

Primary Outcome Measures

Number of participants with postoperative bowel obstruction
Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray
Number of participants with postoperative stoma site hernia
Herni postoperatively on the site of previous stoma detected within 2 years

Secondary Outcome Measures

Number of participants with postoperative complications
Postoperative Hospital stay

Full Information

First Posted
December 8, 2015
Last Updated
January 25, 2023
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02669992
Brief Title
Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: The choice of anastomotic method - does it influence the postoperative course? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasm
Keywords
Ileostomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stapled anastomosis
Arm Type
Experimental
Arm Description
Stapled anastomosis by the use of commercially available linear stapler device
Arm Title
Hand-sewn anastomosis
Arm Type
Active Comparator
Arm Description
Hand-sewn by the use of a resorbable monofilament suture
Arm Title
Abdominal wall mesh closure
Arm Type
Experimental
Arm Description
Closure by the use of a mesh low-weight net device
Arm Title
Abdominal wall suture closure
Arm Type
Active Comparator
Arm Description
Closure by the use of slowly absorbing monofilament suture
Intervention Type
Procedure
Intervention Name(s)
Stapled or Hand-sewn anastomosis
Intervention Description
Randomization between stapled or hand-sewn anastomosis
Intervention Type
Procedure
Intervention Name(s)
Mesh or suture stoma site closure
Intervention Description
Randomization between suture or Mesh closure of the stoma site
Primary Outcome Measure Information:
Title
Number of participants with postoperative bowel obstruction
Description
Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray
Time Frame
30 days
Title
Number of participants with postoperative stoma site hernia
Description
Herni postoperatively on the site of previous stoma detected within 2 years
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Number of participants with postoperative complications
Time Frame
30 days
Title
Postoperative Hospital stay
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pontus Gustafsson, MD
Phone
+46703272152
Email
pontus.gustafsson@gotland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Lindforss, A.P
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska Universitetssjukhuset, Östra sjukhuset
City
Goteborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra wieveg, MD
Facility Name
Centralsjukhuset Karlstad
City
Karlstad
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claes Erixon
Facility Name
Sunderby Sjukhus
City
Lulea
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoffer Odensten
Facility Name
Lycksele lasarett
City
Lycksele
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Norrtälje sjukhus
City
Norrtälje
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecka Zacharias
Facility Name
Skellefteå lasarett
City
Skellefteå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mats Hjortborg
Facility Name
Danderyds sjukhus
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ylva Falken, MD
Facility Name
Karolinska universitetssjukhuset
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrik Lindforss
Facility Name
Norrlands Universitets Sjukhus
City
Umea
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulf Gunnarsson, prof
Facility Name
Region Gotland
City
Visby
ZIP/Postal Code
62149
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pontus Gustafsson, MD
Phone
+46703272152
Email
pontus.gustafsson@gotland.se
Facility Name
Östersunds sjukhus
City
Östersund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pär Nordin

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21845418
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.
Results Reference
background
PubMed Identifier
24033921
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.
Results Reference
background
PubMed Identifier
25276286
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.
Results Reference
background
PubMed Identifier
20372898
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.
Results Reference
background
PubMed Identifier
19102343
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.
Results Reference
background
PubMed Identifier
23095628
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.
Results Reference
background

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

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