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IleostomyROLLINCT00959738

Diverting Loop Ileostomy: With or Without Rod

A study testing Diverting loop ileostomy with rod and diverting loop ileostomy without rod in people with Ileostomy and Rectal Neoplasms, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ileostomy, Rectal Neoplasms
What is being tested?
Diverting loop ileostomy with rod and diverting loop ileostomy without rod
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteSwitzerland
Study dates
Aug 2008to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients scheduled for planned protective loop ileostomy

Who cannot join

  • patients with long-term use of corticosteroids (> 15 mg prednisolone equivalent)
  • immunosuppressive agent rapamune

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Bern University Hospital, Dep. of Visceral and Transplant Surgery

    Bern, 3010

Other trials in Switzerland

About this study

Official title: A Prospective Multicenter Randomized Controlled Clinical Trial to Compare the Method of Protective Diverting Loop Ileostomy With or Without the Support of a Plastic Rod

Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

Read the detailed description

Background

For rectal anastomoses within 6 cm of the anal verge, leakage rates are up to 15%. Here liberal use of protective stomas is widely accepted. Fecal diversion by loop ostomy may also be performed after extended adhesiolysis with serosal lesions and risk of intestinal perforation, in patients with obstructing rectal tumours requiring neoadjuvant radio-chemotherapy or in patients with complex anorectal injuries or fistulas. Generally, diverting loop ileostomies are secured at skin level by means of a supporting device in order to prevent retraction of the loop ileostomy into the abdomen. Nevertheless, due to the supporting rod, difficulties may occur in applying a stoma bag correctly and leakage of feces onto the skin may occur even with correct eversion of the afferent limb. Despite easier application of stoma bags and therefore reduced risk of skin irritation, none of these alternative techniques are established. In various non-randomized studies rodless loop ileostomies were described with an overall morbidity between 3 and 39%. However definition of morbidity varies significantly in these studies and randomised controlled trials are missing so far.

Objective

The aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. Secondary endpoints include stoma care, determinants of quality of life and stoma function.

Methods

The study is designed as multi-institutional, randomized controlled, two-armed study. Patients scheduled for a protective loop ileostomy and meeting the eligibility criteria will be randomized to creation of a loop ileostomy with or without sustaining rod.

Being tested
Diverting loop ileostomy with rod, diverting loop ileostomy without rod
Keywords
loop ileostomy, quality of life, morbidity, Rectal Neoplasms
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diverting loop ileostomy with rodProcedure or surgery

    Diverting loop ileostomy with rod

  • diverting loop ileostomy without rodProcedure or surgery

    diverting loop ileostomy without rod

Study groups in NCT00959738
Study groupRoleWhat they receive
AOtherdiverting loop ileostomy with rod
Receives: Procedure: Diverting loop ileostomy with rod
BOtherdiverting loop ileostomy without rod
Receives: Procedure: diverting loop ileostomy without rod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severe stoma specific morbidity rate

    Measured: postoperative during 2 weeks, 3 months postoperative

Secondary outcomes (4)

  1. Rate of patients reaching self-sufficient stoma care

    Measured: postoperative during 2 weeks

  2. Time used by the stoma nurses for instructing and assisting patients

    Measured in total hours from the intervention up to 3 months postoperatively

    Measured: preoperative, 2 weeks and 3 months postoperative

  3. Quality of life (QoL) by a stoma quality of life scale

    Measured: postoperative during 2 weeks, 3 months postoperative

  4. Predictive factors for stomal complications

    Measured: postoperative during 2 weeks, 3 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2009 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2014
  4. Study completionNov 2014

Why it stopped: Difference found in interim analysis, not ethical to continue

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00959738
Sponsor's protocol ID
061/08
Acronym
ROLLI
Status last verified
Nov 2014
First submitted
14 Aug 2009
Last updated
14 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • Rosen HR, Schiessel R. [Loop enterostomy]. Chirurg. 1999 Jun;70(6):650-5. doi: 10.1007/s001040050701. German.

    PubMed 10427451

  • Gastinger I, Marusch F, Steinert R, Wolff S, Koeckerling F, Lippert H; Working Group 'Colon/Rectum Carcinoma'. Protective defunctioning stoma in low anterior resection for rectal carcinoma. Br J Surg. 2005 Sep;92(9):1137-42. doi: 10.1002/bjs.5045.

    PubMed 15997447

  • Moran B, Heald R. Anastomotic leakage after colorectal anastomosis. Semin Surg Oncol. 2000 Apr-May;18(3):244-8. doi: 10.1002/(sici)1098-2388(200004/05)18:33.0.co;2-6.

    PubMed 10757890

  • Karanjia ND, Corder AP, Bearn P, Heald RJ. Leakage from stapled low anastomosis after total mesorectal excision for carcinoma of the rectum. Br J Surg. 1994 Aug;81(8):1224-6. doi: 10.1002/bjs.1800810850.

    PubMed 7953369

  • Silva MA, Ratnayake G, Deen KI. Quality of life of stoma patients: temporary ileostomy versus colostomy. World J Surg. 2003 Apr;27(4):421-4. doi: 10.1007/s00268-002-6699-4.

    PubMed 12658485

  • Amin SN, Memon MA, Armitage NC, Scholefield JH. Defunctioning loop ileostomy and stapled side-to-side closure has low morbidity. Ann R Coll Surg Engl. 2001 Jul;83(4):246-9.

    PubMed 11518371

  • Edwards DP, Leppington-Clarke A, Sexton R, Heald RJ, Moran BJ. Stoma-related complications are more frequent after transverse colostomy than loop ileostomy: a prospective randomized clinical trial. Br J Surg. 2001 Mar;88(3):360-3. doi: 10.1046/j.1365-2168.2001.01727.x.

    PubMed 11260099

  • Bada-Yllan O, Garcia-Osogobio S, Zarate X, Velasco L, Hoyos-Tello CM, Takahashi T. [Morbi-mortality related to ileostomy and colostomy closure]. Rev Invest Clin. 2006 Nov-Dec;58(6):555-60. Spanish.

    PubMed 17432286

  • Goldstein ET, Williamson PR. A more functional loop ileostomy rod. Dis Colon Rectum. 1993 Mar;36(3):297-8. doi: 10.1007/BF02053516.

    PubMed 8449139

  • Unti JA, Abcarian H, Pearl RK, Orsay CP, Nelson RL, Prasad ML, Duarte B, Leff MM, Tan AB. Rodless end-loop stomas. Seven-year experience. Dis Colon Rectum. 1991 Nov;34(11):999-1004. doi: 10.1007/BF02049964.

    PubMed 1935478

Questions about this trial

What is this clinical trial studying?

A study testing Diverting loop ileostomy with rod and diverting loop ileostomy without rod in people with Ileostomy and Rectal Neoplasms, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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?

The study was stopped early (reason given: Difference found in interim analysis, not ethical to continue). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe stoma specific morbidity rate (time frame: postoperative during 2 weeks, 3 months postoperative). 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 NCT00959738, which also lists 10 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 14 Nov 2014.

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