The Stoma Closure Before or After Adjuvant Therapy Trial

NCT ID: NCT04372992

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-09-01

Brief 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). 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.

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.

Conditions

Ileostomy; Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Early stoma closure

Ileostomy closure between 30 and 40 day after rectal resection

Group Type: EXPERIMENTAL

Timing of stoma closure

Intervention Type: OTHER

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

Delayed stoma closure

Ileostomy closure 15 days from the end of adjuvant therapy (up to 60 days)

Group Type: ACTIVE_COMPARATOR

Timing of stoma closure

Intervention Type: OTHER

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

Interventions

Timing of stoma closure

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rete Oncologica Piemonte, Valle d'Aosta

OTHER

Sponsor Role: collaborator

Ospedale Umberto I di Torino

OTHER

Sponsor Role: lead

Responsible Party

Paolo Massucco

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Massucco, MD

Role: PRINCIPAL_INVESTIGATOR

OA Ordine Mauriziano - Torino, Italy

Locations

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

Acqui Terme, AL, Italy

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

Alessandria, AL, Italy

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

Casale Monferrato, AL, Italy

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

Novi Ligure, AL, Italy

Ospedale Cardinal Massaia - Chirurgia Generale (Dott. Sorisio)

Asti, AT, Italy

Ospedale degli Infermi - Chirurgia Generale (Dott. Polastri)

Biella, BI, Italy

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

Cuneo, CN, Italy

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

Mondovì, CN, Italy

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

Savigliano, CN, Italy

IRCCS - Chirurgia Colorettale (Dott. Ribero)

Candiolo, TO, Italy

Ospedale di Ciriè - Chirurgia Generale (Dott. Personettaz)

Cirié, TO, Italy

Ospedale Civile - Chirurgia Generale (Dott. Rosato)

Ivrea, TO, Italy

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

Moncalieri, TO, Italy

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

Orbassano, TO, Italy

Ospedale Agnelli - Chirurgia Generale (Dott. Muratore)

Pinerolo, TO, Italy

Ospedale degli Infermi - Chirurgia Generale (Dott. Garino)

Rivoli, TO, Italy

Ospedale Cottolengo - Chirurgia Generale (Dott. Bima)

Torino, TO, Italy

Ospedale Humanitas Gradenigo - Chirurgia Generale (Dott. Leli)

Torino, TO, Italy

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

Domodossola, VB, Italy

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

Vercelli, VC, Italy

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

Alba, , Italy

Ospedale Parini - Chirurgia Generale (Dott. Millo)

Aosta, , Italy

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

Novara, , Italy

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

Novara, , Italy

Ospedale Martini - Chirurgia Generale (Dott. Saracco)

Torino, , Italy

Ospedale Mauriziano - Chirurgia Generale (Dott. Ferrero)

Torino, , Italy

Ospedale Molinette - Chirurgia Generale (Dott. De Paolis)

Torino, , Italy

Ospedale Molinette - Chirurgia Universitaria (Prof. Morino)

Torino, , Italy

Countries

Italy

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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.

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Other Identifiers

ROPCR01

Identifier Type: -

Identifier Source: org_study_id