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

Introduction. Anastomotic leak after low anterior resection (LAR) is a life-threatening complication. Preventive stoma formation is the primary method of prevention, but is associated with decreased quality of life and the need for reoperation. Objective: To compare the outcomes of LAR with total mesorectumectomy (TME) with and without a preventive stoma in patients with a low initial risk of leakage.

Materials and methods. This multicenter RCT included patients with rectal cancer who underwent laparoscopic LAR with TME at a low risk of leakage. The study group consisted of patients without stoma formation, while the control group consisted of patients with similar characteristics but with a preventive ileostomy or transverse ileostomy.

Discussion. The advisability of a stoma in low-risk patients remains unresolved. A protocol for a multicenter RCT, the RELOAD-trial, was developed to investigate this issue.

Conclusion. The results will show the incidence of leaks, immediate outcomes, quality of life, and the incidence of ileostomy syndrome in the compared groups.

1. The State of Oncological Care for the Population of Russia in 2024. Edited by A. D. Kaprin, V. V. Starinsky, A. O. Shakhzadova. M. : P. A. Herzen Moscow Oncology Research Institute, a branch of the National Medical Research Center of Radiology of the Ministry of Health of the Russian Federation, 2025, 275 p. (In Russ.)

2. Oncology: Clinical Guidelines of the Ministry of Health of the Russian Federation. Edited by A. D. Kaprin, V. A. Chissov, S. L. Daryalova. 4th edition, corrected and enlarged. M. : GEOTAR-Media, 2022, 784 p. (In Russ.)

3. Alves A., Panis Y., Lelong B., Dousset B., Benoist S., Vicaut E. Randomized clinical trial of early versus delayed temporary stoma closure after proctectomy. British Journal of Surgery, 2008, vol. 95, рр. 693–698. https://doi.org/10.1002/bjs.6218

4. Bray F., Laversanne M., Sung H., Ferlay J., Siegel R. L., Soerjomataram I., Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 2024, vol. 74, № 3, рр. 229–263. https://doi.org/10.3322/caac.21834

5. Cong Z.-J., Hu L.-H., Bian Z.-Q., Ye G.-Y., Yu M.-H., Gao Y.H., Li Z.-S., Yu E.-D., Zhong M. Systematic Review of Anastomotic Leakage Rate According to an International Grading System Following Anterior Resection for Rectal Cancer. PLOS ONE, 2013, vol. 8, № 9, рр. Art. e75519. https://doi.org/10.1371/journal.pone.0075519

6. Denost Q. To drain or not to drain the intraperitoneal anastomosis after rectal excision for cancer: the GRECCAR 5 randomized trial. Annals of Surgery, 2017, vol. 265, № 3, рр. 474–480. https://doi.org/10.1097/SLA.0000000000002020

7. Denost Q., Sylla D., Fleming C., Maillou-Martinaud H., Preaubert-Hayes N., Benard A.; GRECCAR group. 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 Disease, 2023, vol. 25, № 3, рр. 443–452. https://doi.org/10.1111/codi.16428

8. Du R., Zhou J., Tong G., Chang Y., Li D., Wang F., … Wang D. Postoperative morbidity and mortality after anterior resection with preventive diverting loop ileostomy versus loop colostomy for rectal cancer: A updated systematic review and meta-analysis. European Journal of Surgical Oncology, 2021, vol. 47, № 7, рр. 1514–1525. https://doi.org/10.1016/j.ejso.2021.01.030

9. Hernández A.V., Otten J., Christ H., Ulrici C., Piriyev E., Ludwig S., Rudroff C. Ghost Ileostomy: Safe and Cost-effective Alternative to Ileostomy After Rectal Resection for Deep Infiltrating Endometriosis. In Vivo, 2022, vol. 36, № 3, рр. 1290–1296. https://doi.org/10.21873/invivo.12829

10. Matthiessen P., Hallböök O., Rutegård J., Simert G., Sjödahl R. Stoma dysfunction reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a multicenter randomized trial. Annals of Surgery, 2007, vol. 246, рр. 207–214. https://doi.org/10.1097/SLA.0b013e3180603024

11. Mrak K., Uranitsch S., Pedross F., Heuberger A., Klingler A., Jagoditsch M. et al. Bypass ileostomy versus no bypass after low anterior resection for rectal cancer: a prospective randomized multicenter trial. Surgery, 2016, vol. 159, № 4, рр. 1129–1139. https://doi.org/10.1016/j.surg.2015.11.013

12. Ahmad N.Z., Abbas M.H., Khan S.U., Parvaiz A. A metaanalysis of the role of diverting ileostomy after rectal cancer surgery. International Journal of Colorectal Disease, 2020, vol. 35, рр. 2109–2118. https://doi.org/10.1007/s00384-020-03771-z

13. Phan K., Oh L., Ctercteko G., Pathma-Nathan N., Khoury T., Azam H., Wright D., Toh J. W. T. Does a stoma reduce the risk of anastomotic leak and need for re-operation following low anterior resection for rectal cancer: systematic review and metaanalysis of randomized controlled trials. Journal of Gastrointestinal Oncology, 2019, vol. 10, № 2, рр. 179–187. https://doi.org/10.21037/jgo.2018.11.07

14. Schlesinger N. H., Smith H. The effect of a diverting stoma on morbidity and risk of permanent stoma following anastomotic leakage after low anterior resection for rectal cancer: a nationwide cohort study. International Journal of Colorectal Disease, 2020, vol. 35, № 10, рр. 1903–1910. https://doi.org/10.1007/s00384-020-03625-8

15. Snidjers H.S., van den Broek C.B. M., Wouters M.W.J.M., Meershoek-Klein Kranenberg E., Wiggers T., Rutten H. et al. Increasing use of functional stoma after low anterior resection for rectal cancer. Is this the way to go? European Journal of Surgical Oncology, 2013, vol. 39, рр. 715–720. https://doi.org/10.1016/j.ejso.2013.03.010

16. Thoker M., Wani I., Parray F. Q., Khan N., Mir S. A., Thoker P. Role of diversion ileostomy in low rectal cancer: a randomized controlled trial. International Journal of Surgery, 2014, vol. 12, № 9, рр. 945–951. https://doi.org/10.1016/j.ijsu.2014.07.012

17. Ulrich A. B., Seiler C., Rahbari N., Weitz J., Büchler M. W. Diversion stoma after low anterior resection: more arguments in its favour. Diseases of the Colon & Rectum, 2009, vol. 52, № 3. р. 412–418. DOI: 10.1007/DCR.0b013e31819a3c41.

18. Van Cutsem E., Dicato M., Haustermans K., Arber N., Bosset J.-F., Cunningham D. et al. The diagnosis and management of rectal cancer: expert discussion and recommendations derived from the 9th World Congress on Gastrointestinal Cancer, Barcelona, 2007. Annals of Oncology, 2008, vol. 19, № 6, рр. vi1–vi8. https://doi.org/10.1093/annonc/mdn283

19. Visser O., Bakx R., Zoetmulder F. A. N., van Tinteren H., van Lanschot J. J. B. The Influence of total mesorectal excision on local recurrence and survival in rectal cancer patients: a population-based study in Greater Amsterdam. Journal of Surgical Oncology, 2007, vol. 95, № 6, рр. 447–454. https://doi.org/10.1002/jso.20733

20. Vogel I., Reeves N., Tanis P. J., Bemelman W. A., Torkington J., Hompes R., Cornish J. A. Impact of a defunctioning ileostomy and time to stoma closure on bowel function after low anterior resection for rectal cancer: a systematic review and meta-analysis. Techniques in Coloproctology, 2021, vol. 25, № 7, рр. 751–760. DOI: 10.1007/s10151021-02436-5