The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage.
The primary objective is to determine whether the rate of anastomotic leakage within 30 days after surgery in the no-stoma group is non-inferior to that in the diverting stoma group.
The secondary objectives include comparison between groups regarding: Stoma rate at 1 year after surgery; Quality of life at 30 days and 1 year (EORTC QLQ-C30, EORTC QLQ-CR29, and LARS score); Short-term postoperative outcomes, including postoperative day metrics, length of hospital stay, and complications graded according to the Clavien-Dindo classification; Reoperation rates within 30 days and 1 year.
Participants will include adult patients with mid- or low-rectal adenocarcinoma who are scheduled for radical minimally invasive total mesorectal excision and have a predicted risk of anastomotic leakage \<10% according to the study risk model.
Age >18 years;
Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0);
Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;
Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and/or pelvic MRI);
Age ≥80 years;
Presence of a pre-existing diverting ileostomy or colostomy;
Peritumoral abscess or tumor perforation;
Distant metastases (M1) identified preoperatively and/or intraoperatively;
Parallel
Without a preventive stoma
Procedure/SurgeryAt the conclusion of total mesorectal excision (TME), a diverting ileostomy or transverse colostomy will be created at the discretion of the operating surgeon. The pelvic peritoneum over the anastomotic site will be closed, and a pelvic drain will be placed (the type of drain will be determined by the operating surgeon).
With a preventive stoma
Procedure/SurgeryThe operating surgeon will follow the standard practice adopted at the respective center and will create either a diverting ileostomy or transverse colostomy at their discretion. The pelvic peritoneum will not be closed. Placement of a percutaneous pelvic drain adjacent to the anastomotic site is mandatory.
Colorectal anastomotic leak
If anastomotic leakage is suspected in the postoperative period defined by worsening abdominal pain (\>5-point increase on the Visual Analog Scale), signs of peritonitis, drain output containing fibrin or intestinal content, or radiologic findings suggestive of leakage on contrast-enhanced CT of the abdomen and pelvis (with or without proctography) and/or findings at diagnostic laparoscopy. Diagnostic and/or therapeutic measures will be undertaken to confirm or rule out the complication.
Postoperative complications
Postoperative complications will be classified according to the Clavien-Dindo classification
Reoperation rate
During a clinic visit or by telephone interview
Stoma rate
During a clinic visit or by telephone interview
Hospital readmissions
The frequency of repeated admissions to this or other hospitals after the patient's discharge
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