Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial

Andreas T Elsner, Philippe Brosi, Mikolaj Walensi, Michael Uhlmann, Bernhard Egger, Christine Glaser, Christoph A Maurer, Andreas T Elsner, Philippe Brosi, Mikolaj Walensi, Michael Uhlmann, Bernhard Egger, Christine Glaser, Christoph A Maurer

Abstract

Background: The optimum timing for temporary ileostomy closure after low anterior resection is still open.

Objective: This trial aimed to compare early (2 wk) versus late (12 wk) stoma closure.

Design: The study included 2 parallel groups in a multicenter, randomized controlled clinical trial.

Settings: The study was conducted at 3 Swiss hospitals.

Patients: Patients undergoing low anterior resection and temporary ileostomy for cancer were included.

Interventions: Patients were randomly allocated to early or late stoma closure. Before closure, colonic anastomosis was examined for integrity.

Main outcome measures: The primary efficacy outcome was the Gastrointestinal Quality of Life Index 6 weeks after resection. Secondary end points included safety (morbidity), feasibility, and quality of life 4 months after low anterior resection.

Results: The trial was stopped for safety concerns after 71 patients were randomly assigned to early closure (37 patients) or late closure (34 patients). There were comparable baseline data between the groups. No difference in quality of life occurred 6 weeks (mean Gastrointestinal Quality of Life Index: 99.8 vs 106.0; p = 0.139) and 4 months (108.6 vs 107.1; p = 0.904) after index surgery. Intraoperative tendency of oozing (visual analog scale: 35.8 vs 19.3; p = 0.011), adhesions (visual analog scale: 61.3 vs 46.2; p = 0.034), leak of colonic anastomosis (19% vs 0%; p = 0.012), leak of colonic or ileal anastomosis (24% vs 0%; p = 0.002), and reintervention (16% vs 0%; p = 0.026) were significantly higher after early closure. The concept of early closure failed in 10 patients (27% vs 0% in the late closure group (95% CI for the difference, 9.4%-44.4%)).

Limitations: The trial was prematurely stopped because of safety issues. The aimed group size was not reached.

Conclusions: Early stoma closure does not provide better quality of life up to 4 months after low anterior resection but is afflicted with significantly adverse feasibility and higher morbidity when compared with late closure. See Video Abstract at http://links.lww.com/DCR/B665.

Cierre de la ileostoma temporal versus semanas posterior a la reseccin rectal por cncer una advertencia de un estudio multicntrico controlado randomizado prospectivo: ANTECEDENTES:El momento óptimo para el cierre temporal de la ileostomía posterior a la resección anterior baja es aun controversial.OBJETIVO:Este estudio tuvo como objetivo comparar el cierre del estoma temprano (2 semanas) versus tardío (12 semanas).DISEÑO:Estudio clínico controlado, randomizado, multicéntrico, de dos grupos paralelos.ENTORNO CLINICO:El estudio se llevó a cabo en 3 hospitales suizos.PACIENTES:Se incluyeron pacientes sometidos a resección anterior baja e ileostomía temporal por cáncer.INTERVENCIONES:Los pacientes fueron asignados aleatoriamente al cierre del estoma temprano o tardío. Antes del cierre, se examinó la integridad de la anastomosis colónica.PRINCIPALES MEDIDAS DE VALORACION:El principal resultado de eficacia fue el Índice de Calidad de Vida Gastrointestinal 6 semanas después de la resección. Los criterios secundarios incluyeron la seguridad (morbilidad), factibilidad y calidad de vida 4 meses posterior a la resección anterior baja.RESULTADOS:El estudio se detuvo por motivos de seguridad después de que 71 pacientes fueron asignados aleatoriamente a cierre temprano (37 pacientes) o cierre tardío (34 pacientes). Hubo datos de referencia comparables entre los grupos. No se produjeron diferencias en la calidad de vida 6 semanas (índice de calidad de vida gastrointestinal, media 99,8 vs. 106; p = 0,139) y 4 meses (108,6 vs 107,1, p = 0,904) después de la cirugía inicial. Tendencia intraoperatoria de supuración (escala analógica visual 35,8 vs 19,3, p = 0,011), adherencias (escala analógica visual 61,3 vs 46,2, p = 0,034), fuga de anastomosis colónica (19% vs 0%, p = 0,012), fuga de anastomosis colónica o ileal (24% vs 0%, p = 0,002) y reintervención (16% vs 0%, p = 0,026) fueron significativamente mayores después del cierre temprano. El concepto de cierre temprano fracasó en 10 pacientes (27% vs ninguno en el grupo de cierre tardío (intervalo de confianza del 95% para la diferencia: 9,4% a 44,4%)).LIMITACIONES:El estudio se detuvo prematuramente debido a problemas de seguridad. No se alcanzó el tamaño del grupo previsto.CONCLUSIÓN:El cierre temprano del estoma no proporciona una mejor calidad de vida hasta 4 meses posterior a una resección anterior baja, esto se ve afectado por efectos adversos significativos durante su realización y una mayor morbilidad en comparación con el cierre tardío. Consulte Video Resumen en http://links.lww.com/DCR/B665.

Trial registration: ClinicalTrials.gov NCT02609451.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Colon and Rectal Surgeons.

Figures

FIGURE 1.
FIGURE 1.
Schedule of surgical treatments and clinical investigations. GQLI = Gastrointestinal Quality of Life Index; EORTC-QLQ-C30: European Organization for Research and Treatment of Cancer–Quality of Life Questionnaire–Core 30.
FIGURE 2.
FIGURE 2.
CONSORT flow diagram. EC = early closure (closure of protective ileostomy 2 wk after low anterior resection); LC = late closure (closure of protective ileostomy 12 wk after low anterior resection); GQLI = Gastrointestinal Quality of Life Index; EORTC-QLQ-C30: European Organization for Research and Treatment of Cancer–Quality of Life Questionnaire–Core 30.

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Source: PubMed

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