Rectal cancer
Conditions
Interventions
Control Group:Conventional prophylactic stoma (ileostomy or transverse colostomy)
Experimental Group:Tube Ileostomy
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years; 2.American Society of Anesthesiologists (ASA) physical status classification <= III; 3.Rectal adenocarcinoma confirmed by colonoscopy and pathological biopsy; 4.At initial treatment, colonoscopy indicates that the distal margin of the tumor is <= 7 cm from the anal verge, or imaging studies show that the distal tumor margin is located below the peritoneal reflection; 5.Presence of high-risk factors for anastomotic leakage, with the operating surgeon judging that fecal diversion is required intraoperatively; 6.The patient is able to understand the study protocol and is willing to participate in the study, providing written informed consent.
Exclusion criteria
Exclusion criteria: 1.A previous history of malignant colorectal tumors; 2.Preoperative examinations indicating synchronous multiple primary colorectal cancers, or the presence of other diseases requiring additional bowel resection; 3.Preoperative imaging or intraoperative exploration indicating any of the following: (1) Tumor invasion of adjacent organs requiring combined organ resection; (2) Presence of distant metastasis; (3) Inability to achieve R0 resection; (4) Requirement for abdominoperineal resection, transabdominal rectal resection with proximal stoma and distal closure, or Hartmann’s procedure for rectal cancer; 4.A history of any other malignancy within the past 5 years, or familial adenomatous polyposis (FAP), except for cured cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma, or cutaneous squamous cell carcinoma; 5.Concomitant intestinal obstruction, intestinal perforation, or gastrointestinal bleeding requiring emergency surgery; 6.Patients who are not suitable for or unable to tolerate laparoscopic surgery; 7.Pregnant or lactating women; 8.Patients with a history of psychiatric disorders; 9.Patients deemed unsuitable for inclusion in this study based on multidisciplinary team (MDT) discussion; 10.Patients who are unable to understand the study conditions and objectives, or who refuse to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall incidence of grade B and C anastomotic leakage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of complications;Incidence of anastomotic stricture within 1 year;Stoma reversal rate within 1 year;Medical costs;Quality of life; | — |
Countries
China
Contacts
Public ContactQian Liu
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed