Watch-and-Wait Policy to Defer Defunctioning Stoma After Low Anterior Resection: Preliminary Results From the Safe Anastomosis Project (KNUCRC-25CP02).
Source: PubMed, NCBI / U.S. National Library of Medicine
Anastomotic leakage remains a severe complication after low anterior resection for rectal cancer, often leading to the routine use of protective stomas, which can cause additional complications. Inspired by the watch-and-wait approach in rectal cancer treatment, we hypothesized that deferring stoma creation could be feasible through the Safe Anastomosis Project, which includes minimizing technical risk factors, enabling early detection of preclinical leakage, and intervening only when necessary. This study aimed to evaluate whether technical modifications, comprehensive surveillance, and selective stoma creation could reduce the rate of protective stoma use while maintaining acceptable anastomotic leakage rates. Prospective cohort study. The study was conducted at a single-center, tertiary referral hospital. Between January and December 2024, 184 patients underwent curative resection for rectal cancer. A standardized protocol was applied, including perfusion assessment with indocyanine green, single-stapled anastomosis creation using purse-string sutures, reinforcement in a continuous or intermittent manner, extraperitoneal pelvic drain placement, and assessment of anastomotic integrity. Patients were grouped by anastomotic technique: single-stapled with reinforcement, single-stapled alone, or double-stapled with reinforcement. The main outcome measures were the rates of protective stoma creation and anastomotic leakage. A total of 99 patients completed the study protocol. Of
Abstract
Anastomotic leakage remains a severe complication after low anterior resection for rectal cancer, often leading to the routine use of protective stomas, which can cause additional complications. Inspired by the watch-and-wait approach in rectal cancer treatment, we hypothesized that deferring stoma creation could be feasible through the Safe Anastomosis Project, which includes minimizing technical risk factors, enabling early detection of preclinical leakage, and intervening only when necessary. This study aimed to evaluate whether technical modifications, comprehensive surveillance, and selective stoma creation could reduce the rate of protective stoma use while maintaining acceptable anastomotic leakage rates. Prospective cohort study. The study was conducted at a single-center, tertiary referral hospital. Between January and December 2024, 184 patients underwent curative resection for rectal cancer. A standardized protocol was applied, including perfusion assessment with indocyanine green, single-stapled anastomosis creation using purse-string sutures, reinforcement in a continuous or intermittent manner, extraperitoneal pelvic drain placement, and assessment of anastomotic integrity. Patients were grouped by anastomotic technique: single-stapled with reinforcement, single-stapled alone, or double-stapled with reinforcement. The main outcome measures were the rates of protective stoma creation and anastomotic leakage. A total of 99 patients completed the study protocol. Of these, 27 (27.3%) received a protective stoma and 11 (11.1%) developed anastomotic leakage. Patients who underwent a single-stapled technique with reinforcement had the lowest rates of both protective stoma use (18.8%) and anastomotic leakage (6.3%). Robotic surgery was more frequently used in this group (78.1%). Most leakages occurred within 8 days postoperatively and were managed with transanal repair, with or without stoma. This study is limited by its single-center design and modest sample size. Deferral of protective stoma creation after low anterior resection appears feasible. Technical refinement, particularly single-stapled anastomosis with reinforcement and robotic assistance, may optimize outcomes. Further study based on a larger cohort is warranted. See Video Abstract . ANTECEDENTES:La fuga anastomótica sigue siendo una complicación grave tras la resección anterior baja por cáncer rectal, lo que a menudo conduce al uso rutinario de estomas protectores, que pueden causar complicaciones adicionales. Inspirándonos en el enfoque de «observación y espera» en el tratamiento del cáncer rectal, planteamos la hipótesis de que sería factible posponer la creación de un estoma mediante el Proyecto de Anastomosis Segura, que incluye minimizar los factores de riesgo técnicos, permitir la detección precoz de fugas preclínicas e intervenir solo cuando sea necesario.OBJETIVO:Evaluar si las modificaciones técnicas, la vigilancia exhaustiva y la creación selectiva de estomas pueden reducir la tasa de uso de estomas protectores, manteniendo al mismo tiempo tasas aceptables de fuga anastomótica.DISEÑO:Estudio prospectivo de cohortes.ENTORNO:Hospital terciario de referencia, de un solo centro.PACIENTES:Entre enero y diciembre de 2024, 184 pacientes se sometieron a una resección curativa por cáncer rectal.INTERVENCIONES:Se aplicó un protocolo estandarizado que incluía la evaluación de la perfusión con verde de indocianina, la creación de una anastomosis con grapas individuales mediante suturas en bolsa de tabaco, el refuerzo de forma continua o intermitente, la colocación de un drenaje pélvico extraperitoneal y la evaluación de la integridad anastomótica. Los pacientes se agruparon según la técnica anastomótica: grapas individuales con refuerzo, grapas individuales sin refuerzo o grapas dobles con refuerzo.PRINCIPALES MEDIDAS DE RESULTADO:Tasas de creación de estoma protector y fuga anastomótica.RESULTADOS:Un total de 99 pacientes completaron el protocolo del estudio. 27 (27,3 %) recibieron un estoma protector y 11 (11,1 %) desarrollaron fuga anastomótica. Los pacientes con técnica de grapa única con refuerzo tuvieron las tasas más bajas tanto de uso de estoma protector (18,8 %) como de fuga (6,3 %). La cirugía robótica se utilizó con mayor frecuencia en este grupo (78,1 %). La mayoría de las fugas se produjeron en los 8 días posteriores a la operación y se trataron con reparación transanal, con o sin estoma.LIMITACIONES:Diseño de un solo centro y tamaño de muestra modesto.CONCLUSIONES:El aplazamiento de la creación de un estoma protector tras una resección anterior baja parece factible. El perfeccionamiento técnico, en particular la anastomosis con grapas simples con refuerzo y asistencia robótica, puede optimizar los resultados. Se justifica la realización de más estudios basados en cohortes más amplias . (AI-generated translation ).