PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal
      resection rectum is still a debate.

      This study purpose is to demonstrate that preventive loop ileostomy is characterized by a
      higher readmission rate caused by dehydration, in comparison with the loop colostomy.
    

Detailed description: 
      Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is
      proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication
      that reduces quality of life of patients and increases the risk of disease reccurence.

      The presence of preventive stoma is an effective way to avoid this complication that is why
      it's included to treatment protocols for the middle and low ampullary rectal cancers is
      undisputed by the most of surgeons. However, the type of preventive stoma is under discussion
      yet and remains to be an urgent issue.

      The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often
      for the protection of low colorectal anastomoses. 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 the double-barreled transverse colostomy is a preferred method of
      defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and
      related hospital admissions, along with series of unproven advantages.

      Presented study will allow to reveal the early and late postoperative morbidity rate and the
      related hospital re-admissions in real-life clinical practice of Russia from the standpoints
      of evidence- based medicine, to define indications and contraindications for each type of
      "low" colorectal anastomosis protection with the least risk for the patient.
    

Intervention name(s): Low anterior resection with protective loop ileostomy; Low anterior resection with protective loop transverse colostomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning ileostomy is performed.; Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning transverse colostomy is performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: colostomy; ileostomy; rectal cancer; low anterior resection