Post-rectectomy choice of preventive intestinal stoma formation method: prospective multicenter randomized clinical trial protocol

Aim of review. To justify and present the protocol of the prospective, multicenter randomized clinical trial for evaluation of the choice of preventive intestinal stoma formation method after rectectomy. Summary. Modern surgery for the rectal cancer is featured by preferential sphincter-preserving operations. It is established that colorectal anastomosis incompetence is severe and in some cases lethal complication that reduce quality of life of patients and an increase the risk of disease relapses, which rate reaches 15 to 20% at low colorectal anastomosis. Formation of preventive stoma is an effective way to avoid this complication that is why it’s inclusion to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However the choice of preventive stoma formation method is under discussion yet and remains to be an urgent issue. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity. In Russia and CIS countries application of double-barreled transverse colostoma is preferred traditionally due to lower rate of electrolytic disorders and related repetitive hospital admissions in conditions of imperfect stoma care system, along with series of unproven advantages, usually defined as hospital tradition. Conclusion. Presented study will allow to reveal the early and late postoperative morbidity rate and the related repeated hospital admissions in real-life clinical practice of Russia from the standpoints of evidencebased medicine, to define indications and contraindications for each method of «low» colorectal anastomosis protection with the least risk for the patient.

колостома, илеостома, рак прямой кишки, анастомоз, рандомизированное исследование

1. Воробьев Г.И., Севастьянов С.И., Чернышев С.В. Выбор оптимального вида превентивной кишечной стомы. Рос журн гастроэнтерол гепатол колопроктол 2007; 17(2): 69-74.

2. Воробьев Г.И., Царьков П.В., Суханов В.Г., Варданян Л.Х., Калашникова И.А., Оршанский Р.Н. Вопросы организации службы реабилитации стомированных пациентов. Колопроктология 2005; 2:46-52.

3. Воробьев Г.И., Царьков П.В. Хирургия кишечных стом 2002. 55 p.

4. Ем А.Е.Превентивные кишечные стомы при сфинктерсохраняющих операциях по поводу рака прямой кишки: Автореф. СПб; 2008.

5. Каприн А.Д., Петров Г.В. Состояние онкологической помощи населению России в 2015 году. М.; 2016.

6. Половинкин В.В., Порханов В.А., Царьков П.В., Тулина И.А., Волков А.В., Халафян А.А. Ранние осложнения после операций по поводу среднеи нижнеампулярного рака: тотальная мезоректумэктомия или «слепое» выделение прямой кишки? Хирургия. Журнал им. Н.И. Пирогова. 2014; 11:26-33.

7. Суханов В.Г. Социальная реабилитация стомированных инвалидов: зарубежные практики. Cоциальная политика и социология 2015; 14(1): 6-7.

8. Alexander-Williams J. Loop ileostomy and colostomy for faecal diversion. Ann R Coll Surg Engl 1974; 54(3):141-8.

9. Bax T.W., McNevin M.S. The value of diverting loop ileostomy on the high-risk colon and rectal anastomosis. Am J Surg 2007; 193(5):585-7; discussion 587-8.

10. Chun L.J. et al. Defunctioning loop ileostomy for pelvic anastomoses: predictors of morbidity and nonclosure. Dis Colon Rectum 2012; 55(2):167-74.

11. Den Dulk M. et al. Multicentre analysis of oncological and survival outcomes following anastomotic leakage after rectal cancer surgery. Br J Surg 2009; 96(9):1066-75.

12. Edwards D.P. et al. Stoma-related complications are more frequent after transverse colostomy than loop ileostomy: a prospective randomized clinical trial. Br J Surg 2001; 88(3):360-3.

13. Faiz O. et al. Hospital stay amongst patients undergoing major elective colorectal surgery: predicting prolonged stay and readmissions in NHS hospitals. Colorectal Dis 2011; 13(7):816-22.

14. Gastinger I. et al. Protective defunctioning stoma in low anterior resection for rectal carcinoma. Br J Surg 2005; 92(9):1137-42.

15. Geng H.Z. et al. Meta-analysis of elective surgical complications related to defunctioning loop ileostomy compared with loop colostomy after low anterior resection for rectal carcinoma. Ann R Coll Surg Engl 2015; 97(7):494-501.

16. Gooszen A.W. et al. Temporary decompression after colorectal surgery: randomized comparison of loop ileostomy and loop colostomy. Br J Surg 1998; 85(1):76-9.

17. Gooszen A.W. et al. Quality of life with a temporary stoma: ileostomy vs. colostomy. Dis Colon Rectum 2000; 43(5):650-5.

18. Gu W.L., Wu S.W. 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; 13:9.

19. Guenaga K.F. et al. Ileostomy or colostomy for temporary decompression of colorectal anastomosis. Cochrane Database Syst Rev 2007(1):CD004647.

20. Guinier D. et al. Risk factors of unplanned readmission after colorectal surgery: a prospective, multicenter study. Dis Colon Rectum 2007; 50(9):1316-23.

21. Hendren S. et al. Clinical practice guidelines for ostomy surgery. Dis Colon Rectum 2015; 58(4):375-87.

22. Keller D.S. et al. Identifying causes for high readmission rates after stoma reversal. Surg Endosc 2014; 28(4):12638.

23. Khoury G.A. et al. Colostomy or ileostomy after colorectal anastomosis?: a randomised trial. Ann R Coll Surg Engl 1987; 69(1):5-7.

24. Klink C.D. et al. Diversion stoma after colorectal surgery: loop colostomy or ileostomy? Int J Colorectal Dis 2011; 26(4):431-6.

25. Law W.L. et al. Anastomotic leakage is associated with poor long-term outcome in patients after curative colorectal resection for malignancy. J Gastrointest Surg 2007; 11(1):8-15.

26. Law W.L., Chu K.W., Choi H.K. Randomized clinical trial comparing loop ileostomy and loop transverse colostomy for faecal diversion following total mesorectal excision. Br J Surg 2002; 89(6):704-8.

27. Messaris E. et al., Dehydration is the most common indication for readmission after diverting ileostomy creation. Dis Colon Rectum 2012; 55(2):175-80.

28. Ptok H. et al. Impact of anastomotic leakage on oncological outcome after rectal cancer resection. Br J Surg 2007; 94(12):1548-54.

29. Raimes S.A., Mathew V.V., Devlin H.B. Temporary loop ileostomy. J R Soc Med 1984; 77(9):738-41.

30. Rondelli F. et al. Loop ileostomy versus loop colostomy for fecal diversion after colorectal or coloanal anastomosis: a meta-analysis. Int J Colorectal Dis 2009; 24(5): 479-88.

31. Rullier E. et al. Loop ileostomy versus loop colostomy for defunctioning low anastomoses during rectal cancer surgery. World J Surg 2001;. 25(3): 274-7; discussion 277-8.

32. Sakai Y. et al. Temporary transverse colostomy vs loop ileostomy in diversion: a case-matched study. Arch Surg 2001; 136(3):338-42.

33. Steel R.S. et al. The ASCRS textbook of colon and rectal surgery. 2016.

34. Turnbull R.B., Jr., Hawk W.A., Weakley F.L. Surgical treatment of toxic megacolon. Ileostomy and colostomy to prepare patients for colectomy. Am J Surg 1971; 122(3):325-31.

35. Wick E.C. et al. Readmission rates and cost following colorectal surgery. Dis Colon Rectum 2011; 54(12):14759.

36. Williams N.S. et al. De-functioning stomas: a prospective controlled trial comparing loop ileostomy with loop transverse colostomy. Br J Surg 1986; 73(7):566-70.