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IleostomySTOMADNCT04372992

The Stoma Closure Before or After Adjuvant Therapy Trial

A study testing Timing of stoma closure in people with Ileostomy and Rectal Cancer, run by Ospedale Umberto I di Torino at 28 sites in Italy.

Terminated

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

Official record
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Trial summary

This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ileostomy, Rectal Cancer
What is being tested?
Timing of stoma closure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
28 sitesItaly
Study dates
1 Sep 2020to 1 Sep 2022
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

  • Patient treated with a curative resection for rectal cancer
  • Presence of a temporary ileostomy
  • Age >= 18 years
  • Indication to adjuvant treatment
  • Absence of anastomotic dehiscence (as proved by enema and/or endoscopy)
  • Able to give written informed consent

Who cannot join

  • ASA >3
  • ECOG Performance Status >=2
  • UICC stage IV
  • Severe and non-controlled systemic, oncologic, or infectious disease

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Italy28 sites

  • Ospedale Mons. Galliano - Chirurgia Generale (Dott. Serventi)

    Acqui Terme, AL

  • Ospedale S. Lazzaro - Chirurgia Generale (Dott. Calgaro)

    Alba

  • Ospedale SS. Antonio e Biagio - Chirurgia Generale (Dott. Priora)

    Alessandria, AL

  • Ospedale Parini - Chirurgia Generale (Dott. Millo)

    Aosta

  • Ospedale Cardinal Massaia - Chirurgia Generale (Dott. Sorisio)

    Asti, AT

  • Ospedale degli Infermi - Chirurgia Generale (Dott. Polastri)

    Biella, BI

  • IRCCS - Chirurgia Colorettale (Dott. Ribero)

    Candiolo, TO

  • Ospedale S. Spirito - Chirurgia Generale (Dott. Amisano)

    Casale Monferrato, AL

  • Ospedale di Ciriè - Chirurgia Generale (Dott. Personettaz)

    Cirié, TO

  • Ospedale S. Croce e Carle - Chirurgia Generale (Dott. Borghi)

    Cuneo, CN

  • Ospedale S. Biagio - Chirurgia Generale (Dott. Zonta)

    Domodossola, VB

  • Ospedale Civile - Chirurgia Generale (Dott. Rosato)

    Ivrea, TO

  • Ospedale S. Croce - Chirurgia Generale (Dott. Cumbo)

    Moncalieri, TO

  • Ospedale Regina Montis Regalis - Chirurgia Generale (Dott. Gattolin)

    Mondovì, CN

  • Ospedale Maggiore della Carità - Chirurgia Generale (Dott. Romito)

    Novara

  • Ospedale Maggiore della Carità - Chirurgia Universitaria (Prof. Gentilli)

    Novara

  • Ospedale S. Giacomo - Chirurgia Generale (Dott. Di Somma)

    Novi Ligure, AL

  • Ospedale S. Luigi - Chirurgia Universitaria (Prof. Degiuli)

    Orbassano, TO

  • Ospedale Agnelli - Chirurgia Generale (Dott. Muratore)

    Pinerolo, TO

  • Ospedale degli Infermi - Chirurgia Generale (Dott. Garino)

    Rivoli, TO

  • Ospedale SS. Annunziata - Chirurgia Generale (Dott. Bertolino)

    Savigliano, CN

  • Ospedale Cottolengo - Chirurgia Generale (Dott. Bima)

    Torino, TO

  • Ospedale Humanitas Gradenigo - Chirurgia Generale (Dott. Leli)

    Torino, TO

  • Ospedale Martini - Chirurgia Generale (Dott. Saracco)

    Torino

  • Ospedale Mauriziano - Chirurgia Generale (Dott. Ferrero)

    Torino

  • Ospedale Molinette - Chirurgia Generale (Dott. De Paolis)

    Torino

  • Ospedale Molinette - Chirurgia Universitaria (Prof. Morino)

    Torino

  • Ospedale S. Andrea - Chirurgia Generale (Dott. Testa)

    Vercelli, VC

Other trials in Italy

About this study

Official title: Multicenter Randomized Controlled Phase III Trial Comparing Ileostomy Closure Before or After Adjuvant Therapy in Patients Operated for Rectal Cancer

This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it). After a curative resection for rectal cancer and temporary ileostomy, 270 patients with indication to adjuvant chemotherapy will be randomized to early (before starting adjuvant treatment) or late (after adjuvant treatment completion) stoma closure. Primary end point will the compliance to adjuvant therapy. Secondary endpoint will include quality of life and bowel function evaluation, postoperative morbidity, chemotherapy toxicity, oncological outcomes and costs comparison.

Read the detailed description

Diverting ileostomy is effective in reducing severity of anastomotic complications in rectal low anterior resections and it is therefore widely used especially after neoadjuvant chemoradiation treatment. In current clinical practice, in patients with indication to adjuvant chemotherapy, closure of ileostomy is usually performed after the end of the treatment. However, a prolonged presence of the ostomy can induce the onset of ostomy-related complications such as stoma prolapse, parastomal hernia, mechanical ileus, high flow dehydration and damage to renal function. The ostomy-related complications may require unplanned or prolonged hospitalization, thus increasing costs.

Furthermore, the presence of the stoma may affect quality of life, causing alteration of the body image and imposing changes in the daily routine and lifestyle.

Early closure of the ileostomy in patients without signs of postoperative fistula has therefore been proposed.

Outcomes of early closure (within one month from surgery) of diverting ileostomy were demonstrated to be equal to those of late closure (more than 12 weeks from surgery) in 2 randomized trials. Early closure may favor a better quality of life for patients, shortening the life-period with ileostomy, reduces health system economic expenditure and may represent the most desirable and convenient choice. It was also associated with better long term functional results in a randomized trial.

In patients with indication to adjuvant therapy, however, timing to closure of the ostomy (before the start, during or at the end of treatment) is still a matter of debate in terms of compliance to systemic treatment, quality of life and overall costs.

A recent multicenter retrospective study reported an increase in gastrointestinal toxicity in ostomy patients with a significant reduction in treatment compliance.

On the other hand, early closure of the ostomy could unmask anterior resection syndrome (LARS) before chemotherapy, with potential negative impact on the tolerability of the treatment, or reveal postoperative complications thus delaying chemotherapy treatment.

The trial will investigate which is the best strategy of dealing with temporary ileostomy in relation to adjuvant therapy.

Being tested
Timing of stoma closure
Keywords
Chemotherapy, Adjuvant, Early closure, Late closure
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Timing of stoma closureOther

    Defining the best timing of stoma closure in relation to adjuvant therapy compliance

Study groups in NCT04372992
Study groupRoleWhat they receive
Early stoma closureExperimentalIleostomy closure between 30 and 40 day after rectal resection
Receives: Other: Timing of stoma closure
Delayed stoma closureActive comparatorIleostomy closure 15 days from the end of adjuvant therapy (up to 60 days)
Receives: Other: Timing of stoma closure

What is being measured

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

  1. Percentage of participants with good compliance to adjuvant therapy

    Composite outcome measure including timeliness and percentage of planned dose received.

    In each subject, treatment compliance is defined as good if both the following conditions are met:

    1. adjuvant therapy starting date within 10 weeks of rectal resection;
    2. total cumulative received dose (mg/m2) >=70% of planned. The percentage of participants with good compliance in both arms will be compared.

    Measured: Measured within 48 hours after the end of the last cycle of adjuvant therapy

Secondary outcomes (9)

  1. Rate of stoma-related complications

    Adverse events related to the presence of stoma and postoperative complication after stoma closure

    Measured: All over the study duration (up to 12 months from randomization)

  2. Rate of chemotherapy side effects

    According to CTCAE classification

    Measured: Immediately after the end of every single cycle (each cycle duration varies from 5 to 14 days according to the chosen scheme)

  3. Quality of life 1

    Measured by EORTC C30

    Measured: At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization

  4. Quality of life 2

    Measured by EORTC CR29

    Measured: At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization

  5. Quality of life 3

    Measured by EQ-5D-3L

    Measured: At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization

  6. Bowel function

    Measured by LARS (Low Anterior Resection Syndrome) score

    Measured: At 12 months from rectal resection

  7. Overall survival

    From randomization date to death from any cause or date of last contact

    Measured: Ut to 3 years from inclusion of the last patient

  8. Progression free survival

    From randomization date to progression diagnosis or date of last contact

    Measured: Ut to 3 years from inclusion of the last patient

  9. Costs analysis

    Mean cumulative costs in euro of the postoperative phase including outpatient visits, hospital stay for stoma closure, hospital re-entry and expenditures for stoma care appliances based on life-days with the stoma. Excluded are costs related to adjuvant treatment.

    Measured: At 12 months from randomization

Timeline

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

  1. First posted4 May 2020
  2. Study start1 Sep 2020
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Why it stopped: Low accrual - no restart after pandemic suspension

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter controlled trial
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04372992
Sponsor's protocol ID
ROPCR01
Acronym
STOMAD
Status last verified
Sep 2022
First submitted
20 Apr 2020
Last updated
22 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized IPD will be available for 36 months after the results publication upon request to the principal investigator. Data will be provided in an electronic dataset containing deidentified participant files by the Unit of Epidemiology of the Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Turin (Italy) after evaluation and approval of the request by the trial steering committee.

Publications

  • Montedori A, Cirocchi R, Farinella E, Sciannameo F, Abraha I. Covering ileo- or colostomy in anterior resection for rectal carcinoma. Cochrane Database Syst Rev. 2010 May 12;2010(5):CD006878. doi: 10.1002/14651858.CD006878.pub2.

    PubMed 20464746

  • Malik T, Lee MJ, Harikrishnan AB. The incidence of stoma related morbidity - a systematic review of randomised controlled trials. Ann R Coll Surg Engl. 2018 Sep;100(7):501-508. doi: 10.1308/rcsann.2018.0126. Epub 2018 Aug 16.

    PubMed 30112948

  • Brown H, Randle J. Living with a stoma: a review of the literature. J Clin Nurs. 2005 Jan;14(1):74-81. doi: 10.1111/j.1365-2702.2004.00945.x.

    PubMed 15656851

  • Herrle F, Sandra-Petrescu F, Weiss C, Post S, Runkel N, Kienle P. Quality of Life and Timing of Stoma Closure in Patients With Rectal Cancer Undergoing Low Anterior Resection With Diverting Stoma: A Multicenter Longitudinal Observational Study. Dis Colon Rectum. 2016 Apr;59(4):281-90. doi: 10.1097/DCR.0000000000000545.

    PubMed 26953986

  • Alves A, Panis Y, Lelong B, Dousset B, Benoist S, Vicaut E. Randomized clinical trial of early versus delayed temporary stoma closure after proctectomy. Br J Surg. 2008 Jun;95(6):693-8. doi: 10.1002/bjs.6212.

    PubMed 18446781

  • Danielsen AK, Park J, Jansen JE, Bock D, Skullman S, Wedin A, Marinez AC, Haglind E, Angenete E, Rosenberg J. Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2017 Feb;265(2):284-290. doi: 10.1097/SLA.0000000000001829.

    PubMed 27322187

  • Park J, Angenete E, Bock D, Correa-Marinez A, Danielsen AK, Gehrman J, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial). Surg Endosc. 2020 Jan;34(1):69-76. doi: 10.1007/s00464-019-06732-y. Epub 2019 Mar 25.

    PubMed 30911920

  • Keane C, Park J, Oberg S, Wedin A, Bock D, O'Grady G, Bissett I, Rosenberg J, Angenete E. Functional outcomes from a randomized trial of early closure of temporary ileostomy after rectal excision for cancer. Br J Surg. 2019 Apr;106(5):645-652. doi: 10.1002/bjs.11092. Epub 2019 Feb 1.

    PubMed 30706439

  • Tulchinsky H, Shacham-Shmueli E, Klausner JM, Inbar M, Geva R. Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? J Surg Oncol. 2014 Mar;109(3):266-9. doi: 10.1002/jso.23493. Epub 2013 Nov 19.

    PubMed 24249401

  • Robertson JP, Wells CI, Vather R, Bissett IP. Effect of Diversion Ileostomy on the Occurrence and Consequences of Chemotherapy-Induced Diarrhea. Dis Colon Rectum. 2016 Mar;59(3):194-200. doi: 10.1097/DCR.0000000000000531.

    PubMed 26855393

  • Siassi M, Hohenberger W, Losel F, Weiss M. Quality of life and patient's expectations after closure of a temporary stoma. Int J Colorectal Dis. 2008 Dec;23(12):1207-12. doi: 10.1007/s00384-008-0549-2. Epub 2008 Aug 7.

    PubMed 18685854

  • Chow A, Tilney HS, Paraskeva P, Jeyarajah S, Zacharakis E, Purkayastha S. The morbidity surrounding reversal of defunctioning ileostomies: a systematic review of 48 studies including 6,107 cases. Int J Colorectal Dis. 2009 Jun;24(6):711-23. doi: 10.1007/s00384-009-0660-z. Epub 2009 Feb 17.

    PubMed 19221766

  • Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Muller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. doi: 10.1016/S1470-2045(12)70116-X. Epub 2012 Apr 13.

    PubMed 22503032

  • Glynne-Jones R, Counsell N, Quirke P, Mortensen N, Maraveyas A, Meadows HM, Ledermann J, Sebag-Montefiore D. Chronicle: results of a randomised phase III trial in locally advanced rectal cancer after neoadjuvant chemoradiation randomising postoperative adjuvant capecitabine plus oxaliplatin (XELOX) versus control. Ann Oncol. 2014 Jul;25(7):1356-1362. doi: 10.1093/annonc/mdu147. Epub 2014 Apr 8.

    PubMed 24718885

  • Massucco P, Fontana A, Mineccia M, Perotti S, Ciccone G, Galassi C, Giuffrida MC, Marino D, Monsellato I, Paris MK, Perinotti R, Racca P, Monagheddu C, Saccona F, Ponte E, Mistrangelo M, Santarelli M, Tomaselli F, Reddavid R, Birolo S, Calabro M, Pipitone N, Panier Suffat L, Carrera M, Potente F, Brunetti M, Rimonda R, Adamo V, Piscioneri D, Cravero F, Serventi A, Giaminardi E, Mazza L, Bellora P, Colli F, De Rosa C, Battafarano F, Trapani R, Mellano A, Gibin E, Bellomo P. Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial. BMJ Open. 2021 Feb 19;11(2):e044692. doi: 10.1136/bmjopen-2020-044692.

    PubMed 33608405

Questions about this trial

What is this clinical trial studying?

A study testing Timing of stoma closure in people with Ileostomy and Rectal Cancer, run by Ospedale Umberto I di Torino at 28 sites in Italy.

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 6 inclusion and 4 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 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy. 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: Low accrual - no restart after pandemic suspension). 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?

Percentage of participants with good compliance to adjuvant therapy (time frame: Measured within 48 hours after the end of the last cycle of adjuvant therapy). 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 NCT04372992, which also lists 15 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 22 Sep 2022.

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