mossjМосковский хирургический журналMoscow Surgical Journal2072-3180ООО «ПРОФИЛЬ – 2С»10.17238/2072-3180-2026-2-214-230mossj-1220Research ArticleЛИТЕРАТУРНЫЕ ОБЗОРЫLITERARY REVIEWSОценка частоты несостоятельности анастомоза у пациентов низкого риска после низкой передней резекции прямой кишки с формированием превентивной стомы или без нее при плановом лечении по поводу рака прямой кишки: финальный протокол многоцентрового рандомизированного контролируемого исследования не меньшей эффективности – RELOAD trialResults of anastomotic leak after low Anterior resection with or without preventive stoma for rectal cancer in low-risk patients in nonemergency departments (RELOAD): final protocol of multicenter randomized controlled non-inferiority trialhttps://orcid.org/0000-0002-8791-9241ЧерниковскийИ. Л.ChernikovskyI. L.

Черниковский Илья Леонидович – кандидат медицинских наук, заведующий отделением онкоколопроктологии ГБУЗ «МГОБ № 62 ДЗМ».

143423, Московская область, городской округ Красногорск, пос. Истра, д. 27

Ilya L. Chernikovsky – Cand. Sc. (Med.), Head of the Department of Oncocoloproctology of the Moscow City Oncology Hospital no 62 of the Moscow Department of Health.

143423, 27, Poselok Istra, Krasnogorsk City District, Moscow Region

odindra@mail.ruhttps://orcid.org/0000-0002-1326-7893ГончаровА. Л.GoncharovA. L.

Гончаров Артем Леонидович – кандидат медицинских наук, заведующий колопроктологическим отделением ФГБУ "ЦКБ с поликлиникой" Управления делами Президента Российской Федерации.

121359, Москва, Маршала Тимошенко ул., д. 15

Artem L. Goncharov – Cand. Sc. (Med.), Head of the Coloproctology Department of the Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation.

121359, 15, Marshala Timoshenko St, Moscow

goncharovartemleo@gmail.comhttps://orcid.org/0000-0003-3407-4406БурловН. Н.BurlovN. N.

Бурлов Никита Николаевич – врач-хирург хирургического отделения ГАУЗ СО «Верхнесалдинская ЦРБ».

624760, Свердловская область, Верхняя Салда, ул. Рабочей Молодежи, 2-а

Nikita N. Burlov – surgeon of the Surgical Department of the Verkhnyaya Salda Central District Hospital.

624760, 2-а, Rabochey Molodezhi St, Verkhnyaya Salda, Sverdlovsk region

dikefsound@gmail.comhttps://orcid.org/0000-0003-2238-3084СмирновА. A.SmirnovA. A.

Смирнов Алексей Алексеевич – врач-онколог, ГБУЗ ЛОКБ.

194291, пр. Луначарского, д. 45, Санкт-Петербург

Alexey A. Smirnov – oncologist of the Leningrad Regional Clinical Hospital.

194291, 45, Lunacharskogo Ave., St. Petersburg

oncsmirnov@yandex.ruhttps://orcid.org/0000-0002-0249-4759ХрыковГ. Н.KhrykovG. N.

Хрыков Глеб Николаевич – доктор медицинских наук, руководитель стационара №3, врач-онколог, врач-методист.

603093, Нижний Новгород, ул. Родионова, д. 190

Gleb N. Khrykov – Dr. Sc. (Med.), Head of the 3 Department of the State Autonomous Healthcare Institution of Nizhny Novgorod Region «Research Institute of Clinical Oncology «Nizhny Novgorod Regional Clinical Oncology Dispensary».

603093, 190, Rodionova Str., Nizhny Novgorod

ghrykov@mail.ruhttps://orcid.org/0009-0008-8339-3546ТереховВ. М.TerekhovV. M.

Терехов Виталий Михайлович – кандидат медицинских наук, заведующий 1-е онкологического отделения абдоминальной онкологии.

603093, Нижний Новгород, ул. Родионова, д. 190

Vitaly M. Terekhov – Cand. Sc. (Med.), Head of 1st Department of Abdominal Oncology of the State Autonomous Healthcare Institution of Nizhny Novgorod Region «Research Institute of Clinical Oncology «Nizhny Novgorod Regional Clinical Oncology Dispensary»».

603093, 190, Rodionova Str., Nizhny Novgorod

terviralij@yandex.ruhttps://orcid.org/0009-0004-8459-9889АюповР. Т.AyupovR. T.

Аюпов Рустем Талгатович – кандидат медицинских наук, заместитель главного врача по медицинской части.

450054, Уфа, Проспект Октября, д. 73/1

Rustem T. Ayupov – Cand. Sc. (Med.), Deputy Chief Physician for Medical Affairs of the Republican clinical oncological center.

450054, 73/1, Prospect Octyabrya, Ufa

ru2003@bk.ruhttps://orcid.org/0009-0009-9270-8172ФеоктистовД. В.FeoktistovD. V.

Феоктистов Дмитрий Владимирович – кандидат медицинских наук, врач-онколог, заведующий отделением абдоминальной онкологии 2.

450054, Уфа, Проспект Октября, д. 73/1

Dmitry V. Feoktistov – Cand. Sc. (Med.), Oncologist, Head of the Department of Abdominal Oncology 2, of the Republican clinical oncological center.

450054, 73/1, Prospect Octyabrya, Ufa

dimafeoktistov@mail.ruhttps://orcid.org/0000-0001-9439-9873ДаниловМ. А.DanilovM. A.

Данилов Михаил Александрович – доктор медицинских науки, заведующий отделением колопроктологии.

111123, Москва, шоссе Энтузиастов, дом 86, строение 6

Mikhail A. Danilov – Dr. Sc. (Med.), Head of coloproctology Department of the State Budgetary Institution of Healthcare of the city of Moscow «Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow».

111123, 86, building 6, shosse Entuziastov, Moscow

Dma23rus@mail.ruhttps://orcid.org/0000-0002-9611-6459АлиевВ. А.AlievV. A.

Алиев Вячеслав Афандиевич – доктор медицинских науки, ведущий научный сотрудник, хирург-онколог отделения колопроктологии.

111123, Москва, шоссе Энтузиастов, дом 86, строение 6

Vyacheslav A. Aliev – Dr. Sc. (Med.), leading researcher, oncological surgeon of coloproctology Department of the State Budgetary Institution of Healthcare of the city of Moscow «Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow».

111123, 86, building 6, shosse Entuziastov, Moscow

afandiali76@gmail.comhttps://orcid.org/0009-0003-2251-3499МахотинН. В.MakhotinN. V.

Махотин Николай Владимирович – заведующий отделением проктологии, ГАУЗ СО «СООД».

620036, Екатеринбург, ул. Соболева, д. 29

Nikolay V. Makhotin – Head of the proctology Department of the Sverdlovsk Regional Oncological Center.

620036, 29, Soboleva st., Ekaterinburg

n.v.mahotin@mail.ruhttps://orcid.org/0009-0001-2545-1911ГончароваВ. С.GoncharovaV. S.

Гончарова Владислава Сергеевна – студент ФГБОУ ВО «РосУниМед» Минздрава России.

127006, Москва, ул. Долгоруковская, д. 4

Vladislava S. Goncharova – student of the Federal State Budgetary Educational Institution of Higher Education "Russian University of Medicine" of the Ministry of Health of the Russian Federation.

127006, 4, Dolgorukovskaya str., Moscow

vladislava.26@mail.ruАвтономная некоммерческая организация «Научно-практический клуб развития современных медицинских технологий»; ГБУЗ «Московская городская онкологическая больница № 62 Департамента здравоохранения города Москвы»РоссияAutonomous non-profit organization Scientific and Practical Club for the Development of Modern Medical Technologies; Moscow City Oncology Hospital no 62 of the Moscow Department of HealthRussian FederationАвтономная некоммерческая организация «Научно-практический клуб развития современных медицинских технологий»; ФГБУ «Центральная клиническая больница с поликлиникой» Управления делами Президента Российской ФедерацииРоссияAutonomous non-profit organization Scientific and Practical Club for the Development of Modern Medical Technologies; Central Clinical Hospital of the Administrative Directorate of the President of the Russian FederationRussian FederationГАУЗ СО «Верхнесалдинская центральная районная больница»РоссияVerkhnyaya Salda Central District HospitalRussian FederationГБУЗ Ленинградская областная клиническая больницаРоссияLeningrad Regional Clinical HospitalRussian FederationГАУЗ НО «НИИКО «Нижегородский областной клинический онкологический диспансер»»РоссияState Autonomous Healthcare Institution of Nizhny Novgorod Region «Research Institute of Clinical Oncology «Nizhny Novgorod Regional Clinical Oncology Dispensary»»Russian FederationГАУЗ Республиканский клинический онкологический диспансер города Уфы Минздрава Республики БашкортостанРоссияRepublican clinical oncological centerRussian FederationГБУЗ «Московский клинический научно-практический центр имени А.С. Логинова Департамента здравоохранения города Москвы»РоссияState Budgetary Institution of Healthcare of the city of Moscow «Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow»Russian FederationГАУЗ СО «Свердловский областной онкологический диспансер»РоссияSverdlovsk Regional Oncological CenterRussian FederationАвтономная некоммерческая организация «Научно-практический клуб развития современных медицинских технологий»; ФГБОУ ВО «Российский университет медицины» Минздрава РоссииРоссияAutonomous non-profit organization Scientific and Practical Club for the Development of Modern Medical Technologies; Federal State Budgetary Educational Institution of Higher Education "Russian University of Medicine" of the Ministry of Healthcare of the Russian FederationRussian Federation20261606202602214230Copyright © Черниковский И.Л., Гончаров А.Л., Бурлов Н.Н., Смирнов А.A., Хрыков Г.Н., Терехов В.М., Аюпов Р.Т., Феоктистов Д.В., Данилов М.А., Алиев В.А., Махотин Н.В., Гончарова В.С., 20262026Черниковский И.Л., Гончаров А.Л., Бурлов Н.Н., Смирнов А.A., Хрыков Г.Н., Терехов В.М., Аюпов Р.Т., Феоктистов Д.В., Данилов М.А., Алиев В.А., Махотин Н.В., Гончарова В.С.Chernikovsky I.L., Goncharov A.L., Burlov N.N., Smirnov A.A., Khrykov G.N., Terekhov V.M., Ayupov R.T., Feoktistov D.V., Danilov M.A., Aliev V.A., Makhotin N.V., Goncharova V.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.mossj.ru/jour/article/view/1220Введение

Введение. Несостоятельность анастомоза (НА) после низкой передней резекции прямой кишки является жизнеугрожающим осложнением. Формирование превентивной стомы позволяет уменьшить риск его возникновения, но сопровождается снижением качества жизни, необходимостью повторной операции, дополнительными осложнениями, увеличением длительности лечения. По данным литературы в группе пациентов низкого риска выведение стомы не демонстрирует явных преимуществ. Цель исследования – оценить возможность безопасно отказаться от рутинного формирования превентивной стомы при выполнении тотальной мезоректумэктомии (ТМЭ) у пациентов низкого риска НА.

Материалы и методы

Материалы и методы. В многоцентровое рандомизированное исследование не меньшей эффективности будут включаться пациенты низкого риска (вероятность НА 10% и менее), перенесших лапароскопическую ТМЭ по поводу рака прямой кишки. В экспериментальной группе превентивная илео- или трансверзостома не будет формироваться, в контрольной – стандартный подход. В качестве первичной конечной точки будет оцениваться частота несостоятельности колоректального анастомоза.

Обсуждение

Обсуждение. Вопрос целесообразности выведения превентивной стомы при низком риске остается нерешенным. Важно получить данные о возможности безопасно отказаться от ее формирования. Одновременно проводятся исследования GRECCAR 17 и SELSA trial, но их авторы определили другие первичные конечные точки. Наше исследование позволит продемонстрировать результаты на самом важном и объективном исходе, что поможет в определении индивидуальной тактики лечении, улучшения качества жизни пациентов.

Introduction

Introduction. Anastomotic leakage (AL) following low anterior resection (LAR) for rectal cancer is a major complication. Preventive stoma formation reduces the risk of AL. However, it is associated with lower quality of life, reversal surgery, stoma-related complications and prolonged overall treatment. Routine stoma formation does not appear to confer clear benefits in low-risk patients. The aim of this study is to compare the safety outcomes of LAR with and without a preventive stoma in patients with a low initial risk of AL.

Methods

Methods. This multicenter randomized non-inferiority trial will enroll patients classified as low-risk for AL (predicted risk ≤ 10 %) undergoing laparoscopic TME for rectal cancer. In the experimental group, preventive ileostomy or colostomy will not be performed. In the control group – standard practice. The primary endpoint will be the incidence of colorectal anastomotic leak.

Discussion

Discussion. The problem of preventive stoma is not solved in low predicted risk population. New evidence is needed to determine whether routine stoma formation can be safely omitted in these patients. Ongoing trials, including GRECCAR 17 and the SELSA trial, address related questions but have defined different primary endpoints. The present study focuses on the most clinically relevant and objective outcome – rate anastomotic leak. The results will help to support individualized surgical decision-making and improve the quality of life.

рак прямой кишкитотальная мезоректумэктомияпревентивная стомарандомизированное исследованиенизкий рискrectal cancertotal mesorectumectomypreventive stomarandomized triallow-risk patientsReferencesHofheinz R.D., Fokas E., Benhaim L. et al. Localised rectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol, 2025, no 36 (9), pp. 1007–1024. https://doi.org/10.1016/j.annonc.2025.05.528Hofheinz R.D., Fokas E., Benhaim L. et al. Localised rectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol, 2025, no 36 (9), pp. 1007–1024. https://doi.org/10.1016/j.annonc.2025.05.528Scott A.J., Kennedy E.B., Berlin J. et al. Management of Locally Advanced Rectal Cancer: ASCO Guideline. J Clin Oncol, 2024, no 42 (28), pp. 3355–3375. https://doi.org/10.1200/JCO.24.01160Scott A.J., Kennedy E.B., Berlin J. et al. Management of Locally Advanced Rectal Cancer: ASCO Guideline. J Clin Oncol, 2024, no 42 (28), pp. 3355–3375. https://doi.org/10.1200/JCO.24.01160Benson A.B., Venook A.P., Adam M. et al. NCCN Guidelines® Insights: Rectal Cancer, Version 3.2024: Featured Updates to the NCCN Guidelines. J Natl Compr Canc Netw, 2024, no 22 (6), pp. 366–375. https://doi.org/10.6004/jnccn.2024.0041Benson A.B., Venook A.P., Adam M. et al. NCCN Guidelines® Insights: Rectal Cancer, Version 3.2024: Featured Updates to the NCCN Guidelines. J Natl Compr Canc Netw, 2024, no 22 (6), pp. 366–375. https://doi.org/10.6004/jnccn.2024.0041Федянин М.Ю., Гладков О.А., Гордеев С.С. et al. Рак ободочной кишки, ректосигмоидного соединения и прямой кишки. Клинические рекомендации RUSSCO, часть 1.1. Злокачественные опухоли. 2025. № 15 (3s2-1.1). С. 310–372. https://doi.org/10.18027/2224-5057-2025-15-3s2-1.1-14Fedyanin M.Yu., Gladkov O.A., Gordeev S.S. et al. Cancer of the colon, rectosigmoid junction and rectum. Malig Tumours, 2025, no 15 (3s2-1.1), pp. 310–372. (In Russ.) https://doi.org/10.18027/2224-5057-2025-15-3s2-1.1-14Penna M., Hompes R., Arnold S., et al. Incidence and Risk Factors for Anastomotic Failure in 1594 Patients Treated by Transanal Total Mesorectal Excision: Results from the International TaTME Registry. Ann Surg., 2019, no 269 (4), pp. 700–711. https://doi.org/10.1097/SLA.0000000000002653McDermott F.D., Heeney A., Kelly M.E., Steele R.J., Carlson G.L., Winter D.C. Systematic review of preoperative, intraoperative and post-operative risk factors for colorectal anastomotic leaks. Br J Surg., 2015, no 102 (5), pp. 462–479. https://doi.org/10.1002/bjs.9697McDermott F.D., Heeney A., Kelly M.E., Steele R.J., Carlson G.L., Winter D.C. Systematic review of preoperative, intraoperative and post-operative risk factors for colorectal anastomotic leaks. Br J Surg., 2015, no 102 (5), pp. 462–479. https://doi.org/10.1002/bjs.9697Hol J.C., Burghgraef T.A., Rutgers M.L.W. et al. Impact of a diverting ileostomy in total mesorectal excision with primary anastomosis for rectal cancer. Surg Endosc, 2023, no 37 (3), pp. 1916–1932. https://doi.org/10.1007/s00464-022-09669-xHol J.C., Burghgraef T.A., Rutgers M.L.W. et al. Impact of a diverting ileostomy in total mesorectal excision with primary anastomosis for rectal cancer. Surg Endosc, 2023, no 37 (3), pp. 1916–1932. https://doi.org/10.1007/s00464-022-09669-xPisarska M., Gajewska N., Małczak P. et al. Defunctioning ileostomy reduces leakage rate in rectal cancer surgery – systematic review and meta-analysis. Oncotarget, 2018, no 9 (29), pp. 20816–2025. https://doi.org/10.18632/oncotarget.25015Pisarska M., Gajewska N., Małczak P. et al. Defunctioning ileostomy reduces leakage rate in rectal cancer surgery – systematic review and meta-analysis. Oncotarget, 2018, no 9 (29), pp. 20816–2025. https://doi.org/10.18632/oncotarget.25015Kostov G.G., Dimov R.S., Almeida D.D. Risk Factors for Anastomotic Leakage after Low Anterior Resection. Folia Med (Plovdiv), 2020, no 62 (2), pp. 290–294. https://doi.org/10.3897/folmed.62.e47727Kostov G.G., Dimov R.S., Almeida D.D. Risk Factors for Anastomotic Leakage after Low Anterior Resection. Folia Med (Plovdiv), 2020, no 62 (2), pp. 290–294. https://doi.org/10.3897/folmed.62.e47727Matthiessen P., Hallböök O., Rutegård J., Simert G., Sjödahl R. Defunctioning Stoma Reduces Symptomatic Anastomotic Leakage After Low Anterior Resection of the Rectum for Cancer: A Randomized Multicenter Trial. Ann Surg, 2007, no 246 (2), pp. 207–214. https://doi.org/10.1097/SLA.0b013e3180603024Matthiessen P., Hallböök O., Rutegård J., Simert G., Sjödahl R. Defunctioning Stoma Reduces Symptomatic Anastomotic Leakage After Low Anterior Resection of the Rectum for Cancer: A Randomized Multicenter Trial. Ann Surg, 2007, no 246 (2), pp. 207–214. https://doi.org/10.1097/SLA.0b013e3180603024Gu W. long, Wu S. wen. Meta-analysis of defunctioning stoma in low anterior resection with total mesorectal excision for rectal cancer: evidence based on thirteen studies. World J Surg Oncol, 2015, no 13 (9), pp. 1–6. https://doi.org/10.1186/s12957-014-0417-1Gu W. long, Wu S. wen. Meta-analysis of defunctioning stoma in low anterior resection with total mesorectal excision for rectal cancer: evidence based on thirteen studies. World J Surg Oncol, 2015, no 13 (9), pp. 1–6. https://doi.org/10.1186/s12957-014-0417-1Phan K., Oh L., Ctercteko G. et al. Does a stoma reduce the risk of anastomotic leak and need for re-operation following low anterior resection for rectal cancer: systematic review and meta-analysis of randomized controlled trials. J Gastrointest Oncol, 2019, no 10 (2), pp. 179–187. https://doi.org/10.21037/jgo.2018.11.07Phan K., Oh L., Ctercteko G. et al. Does a stoma reduce the risk of anastomotic leak and need for re-operation following low anterior resection for rectal cancer: systematic review and meta-analysis of randomized controlled trials. J Gastrointest Oncol, 2019, no 10 (2), pp. 179–187. https://doi.org/10.21037/jgo.2018.11.07Yang S., Tang G., Zhang Y., Wei Z., Du D. Meta-analysis: loop ileostomy versus colostomy to prevent complications of anterior resection for rectal cancer. Int J Colorectal Dis, 2024, no 39 (68), pp. 1–18. https://doi.org/10.1007/s00384-024-04639-2Yang S., Tang G., Zhang Y., Wei Z., Du D. Meta-analysis: loop ileostomy versus colostomy to prevent complications of anterior resection for rectal cancer. Int J Colorectal Dis, 2024, no 39 (68), pp. 1–18. https://doi.org/10.1007/s00384-024-04639-2Holmgren K., Kverneng Hultberg D., Haapamäki M.M., Matthiessen P., Rutegård J., Rutegård M. High stoma prevalence and stoma reversal complications following anterior resection for rectal cancer: a population‐based multicentre study. Colorectal Dis, 2017, no 19 (12), pp. 1067–1075. https://doi.org/10.1111/codi.13771Holmgren K., Kverneng Hultberg D., Haapamäki M.M., Matthiessen P., Rutegård J., Rutegård M. High stoma prevalence and stoma reversal complications following anterior resection for rectal cancer: a population‐based multicentre study. Colorectal Dis, 2017, no 19 (12), pp. 1067–1075. https://doi.org/10.1111/codi.13771Murken D., Bleier J. Ostomy-related complications. Clin Colon Rectal Surg, 2019, no 32 (03), pp. 176–182. https://doi.org/10.1055/s-0038-1676995Murken D., Bleier J. Ostomy-related complications. Clin Colon Rectal Surg, 2019, no 32 (03), pp. 176–182. https://doi.org/10.1055/s-0038-1676995Näsvall P., Dahlstrand U., Löwenmark T., Rutegård J., Gunnarsson U., Strigård K. Quality of life in patients with a permanent stoma after rectal cancer surgery. Qual Life Res, 2017, no 26 (1), pp. 55–64. https://doi.org/10.1007/s11136-016-1367-6Näsvall P., Dahlstrand U., Löwenmark T., Rutegård J., Gunnarsson U., Strigård K. Quality of life in patients with a permanent stoma after rectal cancer surgery. Qual Life Res, 2017, no 26 (1), pp. 55–64. https://doi.org/10.1007/s11136-016-1367-6Neuman H.B., Park J., Fuzesi S., Temple L.K. Rectal Cancer patients’ quality of life with a temporary stoma: shifting perspectives. Dis Colon Rectum, 2012, no 55 (11), pp. 1117–1124. https://doi.org/10.1097/DCR.0b013e3182686213Neuman H.B., Park J., Fuzesi S., Temple L.K. Rectal Cancer patients’ quality of life with a temporary stoma: shifting perspectives. Dis Colon Rectum, 2012, no 55 (11), pp. 1117–1124. https://doi.org/10.1097/DCR.0b013e3182686213Massucco P., Fontana A., Mineccia M. et al. 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, no 11 (2), pp. 1–8. https://doi.org/10.1136/bmjopen-2020-044692Massucco P., Fontana A., Mineccia M. et al. 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, no 11 (2), pp. 1–8. https://doi.org/10.1136/bmjopen-2020-044692Podda M., Coccolini F., Gerardi C. et al. Early versus delayed defunctioning ileostomy closure after low anterior resection for rectal cancer: a meta-analysis and trial sequential analysis of safety and functional outcomes. Int J Colorectal Dis, 2022, no 37 (4), pp. 737–756. https://doi.org/10.1007/s00384-022-04106-wPodda M., Coccolini F., Gerardi C. et al. Early versus delayed defunctioning ileostomy closure after low anterior resection for rectal cancer: a meta-analysis and trial sequential analysis of safety and functional outcomes. Int J Colorectal Dis, 2022, no 37 (4), pp. 737–756. https://doi.org/10.1007/s00384-022-04106-wHuisman D.E., Ingwersen E.W., Reudink M. et al. The Selective Use of a Diverting Stoma in Rectal Surgery. J Gastrointest Surg, 2022, no 26 (7), pp. 1509–1512. https://doi.org/10.1007/s11605-022-05251-xHuisman D.E., Ingwersen E.W., Reudink M. et al. The Selective Use of a Diverting Stoma in Rectal Surgery. J Gastrointest Surg, 2022, no 26 (7), pp. 1509–1512. https://doi.org/10.1007/s11605-022-05251-xPata G., D’Hoore A., Fieuws S., Penninckx F. Mortality risk analysis following routine vs selective defunctioning stoma formation after total mesorectal excision for rectal cancer. Colorectal Dis, 2009, no 11 (8), pp. 797–805. https://doi.org/10.1111/j.1463-1318.2008.01693.xPata G., D’Hoore A., Fieuws S., Penninckx F. Mortality risk analysis following routine vs selective defunctioning stoma formation after total mesorectal excision for rectal cancer. Colorectal Dis, 2009, no 11 (8), pp. 797–805. https://doi.org/10.1111/j.1463-1318.2008.01693.xRutegård M., Lindsköld M., Jörgren F. et al. SELECTIvE defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma‐free survival without major LARS following total mesorectal excision. Colorectal Dis, 2025, no 27 (2), pp. 1–10. https://doi.org/10.1111/codi.70009Rutegård M., Lindsköld M., Jörgren F. et al. SELECTIvE defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma‐free survival without major LARS following total mesorectal excision. Colorectal Dis, 2025, no 27 (2), pp. 1–10. https://doi.org/10.1111/codi.70009Munshi E., Lydrup M.L., Buchwald P. Defunctioning stoma in anterior resection for rectal cancer does not impact anastomotic leakage: a national population-based cohort study. BMC Surg, 2023, no 23 (167), pp. 1–7. https://doi.org/10.1186/s12893-023-01998-5Munshi E., Lydrup M.L., Buchwald P. Defunctioning stoma in anterior resection for rectal cancer does not impact anastomotic leakage: a national population-based cohort study. BMC Surg, 2023, no 23 (167), pp. 1–7. https://doi.org/10.1186/s12893-023-01998-5Boissieras L., Harji D., Celerier B., Rullier E., Denost Q. TAI-LORED STOMA POLICY after TME for rectal cancer: The TASTY approach. Colorectal Dis, 2024, no 26 (9), pp. 1683–1692. https://doi.org/10.1111/codi.17095Boissieras L., Harji D., Celerier B., Rullier E., Denost Q. TAI-LORED STOMA POLICY after TME for rectal cancer: The TASTY approach. Colorectal Dis, 2024, no 26 (9), pp. 1683–1692. https://doi.org/10.1111/codi.17095Denost Q., Sylla D., Fleming C. et al. A phase III randomized trial evaluating the quality of life impact of a tailored versus systematic use of defunctioning ileostomy following total mesorectal excision for rectal cancer – GRECCAR 17 trial protocol. Colorectal Dis, 2023, no 25 (3), pp. 443–452. https://doi.org/10.1111/codi.16428Denost Q., Sylla D., Fleming C. et al. A phase III randomized trial evaluating the quality of life impact of a tailored versus systematic use of defunctioning ileostomy following total mesorectal excision for rectal cancer – GRECCAR 17 trial protocol. Colorectal Dis, 2023, no 25 (3), pp. 443–452. https://doi.org/10.1111/codi.16428Burlov N.N. Comment on ‘A phase III randomized trial evaluating the quality of life impact of a tailored versus systematic use of defunctioning ileostomy following total mesorectal excision for rectal cancer – GRECCAR 17 trial protocol.’ Colorectal Dis, 2025, no 27 (11), pp. 1–2. https://doi.org/10.1111/codi.70300Burlov N.N. Comment on ‘A phase III randomized trial evaluating the quality of life impact of a tailored versus systematic use of defunctioning ileostomy following total mesorectal excision for rectal cancer – GRECCAR 17 trial protocol.’ Colorectal Dis, 2025, no 27 (11), pp. 1–2. https://doi.org/10.1111/codi.70300Smirnov A.A., Chernikovsky I.L., Khrykov G.N. et al. Comparative results of performing low anterior rectal resection without the formation of a preventive stoma and with the formation of a preventive transverse ostomy and/or ileostomy in a routine ward: protocol for a multicenter randomized controlled trial. Moscow Surgical Journal, 2026, no 1, pp. 235–245. (In Russ.) https://doi.org/10.17238/2072-3180-2026-1-235-245Смирнов А.А., Черниковский И.Л., Хрыков Г.Н., Шереметьев Д.Ю., Аюпов Р.Т., Феоктистов Д.В., Гончаров А.Л., Чир-Чир Э.М., Бурлов Н.Н., Гончарова В.С. Сравнительные результаты выполнения низкой передней резекции прямой кишки без формирования превентивной стомы и с формированием превентивной трансверзостомы и/или илеостомы в плановом отделении: протокол многоцентрового рандомизированного контролируемого исследования. Московский хирургический журнал. 2026. № 1. С. 235–245. https://doi.org/10.17238/2072-3180-2026-1-235-245Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration. November, 2016.Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration. November, 2016.Chow S.C., Shao J., Wang H., Lokhnygina Y. Sample Size Calculations in Clinical Research: Third Edition. 3rd ed. (Chow SC, Shao J, Wang H, Lokhnygina Y, eds.). Chapman and Hall/CRC; 2017. https://doi.org/10.1201/9781315183084Chow S.C., Shao J., Wang H., Lokhnygina Y. Sample Size Calculations in Clinical Research: Third Edition. 3rd ed. (Chow SC, Shao J, Wang H, Lokhnygina Y, eds.). Chapman and Hall/CRC; 2017. https://doi.org/10.1201/9781315183084Litchinko A., Buchs N., Balaphas A. et al. Score prediction of anastomotic leak in colorectal surgery: a systematic review. Surg Endosc, 2024, no 38 (4), pp. 1723–1730. https://doi.org/10.1007/s00464-024-10705-1Litchinko A., Buchs N., Balaphas A. et al. Score prediction of anastomotic leak in colorectal surgery: a systematic review. Surg Endosc, 2024, no 38 (4), pp. 1723–1730. https://doi.org/10.1007/s00464-024-10705-1Litchinko A., Buchs N., Balaphas A. et al. Score prediction of anastomotic leak in colorectal surgery: a systematic review. Surg Endosc, 2024, no 38 (4), pp. 1723–1730. https://doi.org/10.1007/s00464-024-10705-1

The authors declare that there are no conflicts of interest present.