NCT02669992

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. 1.The choice of anastomotic method - does it influence the postoperative course?
  2. 2.The use of a prophylactic mesh when closing the stoma site - will there be less hernias?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jun 2015Dec 2027

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

11.5 years

First QC Date

December 8, 2015

Last Update Submit

January 25, 2023

Conditions

Rectal Neoplasm

Keywords

Ileostomy

Outcome Measures

Primary Outcomes (2)

  • Number of participants with postoperative bowel obstruction

    Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray

    30 days

  • Number of participants with postoperative stoma site hernia

    Herni postoperatively on the site of previous stoma detected within 2 years

    2 year

Secondary Outcomes (2)

  • Number of participants with postoperative complications

    30 days

  • Postoperative Hospital stay

    30 days

Study Arms (4)

Stapled anastomosis

EXPERIMENTAL

Stapled anastomosis by the use of commercially available linear stapler device

Procedure: Stapled or Hand-sewn anastomosis

Hand-sewn anastomosis

ACTIVE COMPARATOR

Hand-sewn by the use of a resorbable monofilament suture

Procedure: Stapled or Hand-sewn anastomosis

Abdominal wall mesh closure

EXPERIMENTAL

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

Procedure: Mesh or suture stoma site closure

Abdominal wall suture closure

ACTIVE COMPARATOR

Closure by the use of slowly absorbing monofilament suture

Procedure: Mesh or suture stoma site closure

Interventions

Stapled or Hand-sewn anastomosisPROCEDURE

Randomization between stapled or hand-sewn anastomosis

Hand-sewn anastomosisStapled anastomosis
Mesh or suture stoma site closurePROCEDURE

Randomization between suture or Mesh closure of the stoma site

Abdominal wall mesh closureAbdominal wall suture closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patient unable to understand written or oral information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Sahlgrenska Universitetssjukhuset, Östra sjukhuset

Gothenburg, Sweden

RECRUITING

Centralsjukhuset Karlstad

Karlstad, Sweden

RECRUITING

Sunderby Sjukhus

Luleå, Sweden

RECRUITING

Lycksele lasarett

Lycksele, Sweden

RECRUITING

Norrtälje sjukhus

Norrtälje, Sweden

RECRUITING

Östersunds sjukhus

Östersund, Sweden

RECRUITING

Skellefteå lasarett

Skellefteå, Sweden

RECRUITING

Danderyds sjukhus

Stockholm, Sweden

RECRUITING

Karolinska universitetssjukhuset

Stockholm, Sweden

RECRUITING

Norrlands Universitets Sjukhus

Umeå, Sweden

RECRUITING

Region Gotland

Visby, 62149, Sweden

RECRUITING

Related Publications (6)

  • 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.

    PMID: 21845418BACKGROUND

  • 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.

    PMID: 24033921BACKGROUND

  • 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.

    PMID: 25276286BACKGROUND

  • 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.

    PMID: 20372898BACKGROUND

  • 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.

    PMID: 19102343BACKGROUND

  • 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.

    PMID: 23095628BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Ulrik Lindforss, A.P

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pontus Gustafsson, MD

CONTACT

+46703272152pontus.gustafsson@gotland.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 8, 2015

First Posted

February 1, 2016

Study Start

June 1, 2015

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(11)