Rectal NeoplasmLISTONCT02669992
Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
A study testing Stapled or Hand-sewn anastomosis and Mesh or suture stoma site closure in people with Rectal Neoplasm, run by Karolinska University Hospital at 11 sites in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasm
- What is being tested?
- Stapled or Hand-sewn anastomosis and Mesh or suture stoma site closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 11 sitesSweden
- Study dates
- Jun 2015to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- loop ileostomy after rectal cancer surgery
- loop ileostomy closure is permitted and possible according to clinical practice
Who cannot join
- patient unable to understand written or oral information
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Sweden11 sites, 11 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset, Östra sjukhuset
Gothenburg
Petra wieveg, MD
- Recruiting
Centralsjukhuset Karlstad
Karlstad
Claes Erixon
- Recruiting
Sunderby Sjukhus
Luleå
Christoffer Odensten
- Recruiting
Lycksele lasarett
Lycksele
- Recruiting
Norrtälje sjukhus
Norrtälje
Rebecka Zacharias
- Recruiting
Östersunds sjukhus
Östersund
Pär Nordin
- Recruiting
Skellefteå lasarett
Skellefteå
Mats Hjortborg
- Recruiting
Danderyds sjukhus
Stockholm
Ylva Falken, MD
- Recruiting
Karolinska universitetssjukhuset
Stockholm
Ulrik Lindforss
- Recruiting
Norrlands Universitets Sjukhus
Umeå
Ulf Gunnarsson, prof
- Recruiting
Region Gotland
Visby, 62149
Pontus Gustafsson, MD, +46703272152, pontus.gustafsson@gotland.se
About this study
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.
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?
Read the 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.
- Conditions
- Rectal Neoplasm
- Being tested
- Stapled or Hand-sewn anastomosis, Mesh or suture stoma site closure
- Keywords
- Ileostomy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapled or Hand-sewn anastomosisProcedure or surgery
Randomization between stapled or hand-sewn anastomosis
Mesh or suture stoma site closureProcedure or surgery
Randomization between suture or Mesh closure of the stoma site
| Study group | Role | What they receive |
|---|---|---|
| Stapled anastomosis | Experimental | Stapled anastomosis by the use of commercially available linear stapler device Receives: Procedure: Stapled or Hand-sewn anastomosis |
| Hand-sewn anastomosis | Active comparator | Hand-sewn by the use of a resorbable monofilament suture Receives: Procedure: Stapled or Hand-sewn anastomosis |
| Abdominal wall mesh closure | Experimental | Closure by the use of a mesh low-weight net device Receives: Procedure: Mesh or suture stoma site closure |
| Abdominal wall suture closure | Active comparator | Closure by the use of slowly absorbing monofilament suture Receives: Procedure: Mesh or suture stoma site closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative bowel obstruction
Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray
Measured: 30 days
Number of participants with postoperative stoma site hernia
Herni postoperatively on the site of previous stoma detected within 2 years
Measured: 2 year
Secondary outcomes (2)
Number of participants with postoperative complications
Measured: 30 days
Postoperative Hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrik Lindforss, Karolinska University Hospital
- Investigators
- Ulrik Lindforss, A.P, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669992
- Sponsor's protocol ID
- 2015/321-31/1
- Acronym
- LISTO
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2015
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21845418Gong 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.
PubMed 24033921Rubio-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.
PubMed 25276286Akiyoshi 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.
PubMed 20372898Chude 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.
PubMed 19102343Loffler 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.
PubMed 23095628
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02669992
- Acronym / sponsor ID
- LISTO / 2015/321-31/1
- Conditions
- Rectal Neoplasm
- Keywords
- Ileostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stapled anastomosis | Experimental | Procedure: Stapled or Hand-sewn anastomosisStapled anastomosis by the use of commercially available linear stapler device |
| Hand-sewn anastomosis | Active comparator | Procedure: Stapled or Hand-sewn anastomosisHand-sewn by the use of a resorbable monofilament suture |
| Abdominal wall mesh closure | Experimental | Procedure: Mesh or suture stoma site closureClosure by the use of a mesh low-weight net device |
| Abdominal wall suture closure | Active comparator | Procedure: Mesh or suture stoma site closureClosure by the use of slowly absorbing monofilament suture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- loop ileostomy after rectal cancer surgery
- loop ileostomy closure is permitted and possible according to clinical practice
Key exclusion criteria (1 listed)
- patient unable to understand written or oral information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapled or Hand-sewn anastomosisRandomization between stapled or hand-sewn anastomosis | Procedure or surgery | Hand-sewn anastomosis, Stapled anastomosis |
| Mesh or suture stoma site closureRandomization between suture or Mesh closure of the stoma site | Procedure or surgery | Abdominal wall mesh closure, Abdominal wall suture closure |
Primary outcome
Number of participants with postoperative bowel obstruction
Time frame: 30 days
Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray
Number of participants with postoperative stoma site hernia
Time frame: 2 year
Herni postoperatively on the site of previous stoma detected within 2 years
2 secondary outcomes
Number of participants with postoperative complications
Time frame: 30 days
Postoperative Hospital stay
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 21845418Gustavsson 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.
- Background: PubMed 24033921Gong 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.
- Background: PubMed 25276286Rubio-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.
- Background: PubMed 20372898Akiyoshi 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.
- Background: PubMed 19102343Chude 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.
- Background: PubMed 23095628Loffler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulrik Lindforss, A.P principal investigator
Karolinska University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapled or Hand-sewn anastomosis and Mesh or suture stoma site closure in people with Rectal Neoplasm, run by Karolinska University Hospital at 11 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pontus Gustafsson, MD (+46703272152, pontus.gustafsson@gotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative bowel obstruction (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02669992, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.