Table 1.
Inclusion, exclusion, and withdrawal criteria
| Inclusion criteria | Exclusion criteria | Withdrawal criteria |
|---|---|---|
| • 18 years < age < 80 years | • BMI > 30 kg/m2 | • Invasion of adjacent structures or distant metastasis |
| • Tumor located in the rectosigmoid (defined as 10 to 30 cm from the anal verge, measured via colonoscopy or EUS) | • Pregnant or lactating women | • Inability to undergo surgery or anesthesia because of a changing illness state |
| • Pathological rectosigmoid cancer | • Severe mental disease | • Changing illness state requires an emergency operation |
| • Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of the AJCC Cancer Staging Manual (measured using abdominal CT and colonoscopy or EUS) | • Previous abdominal surgery (except extraperitoneal surgery) | • Intraoperative colon irrigation |
| • Tumor size of 5 cm or less | • Emergency operation to treat complications (bleeding, perforation, or obstruction) caused by colorectal cancer | • Serious protocol violations |
| • ECOG performance status of 0 to 1 | • Need for simultaneous surgery for another disease | • Patient required to withdraw |
| • ASA classification I to III | • Malignant disease within the previous 5 years (except superficial squamous or basal cell cancer of the skin or in situ cancer of the cervix) | |
| • Informed consent | • Nonspeaker of Chinese or English |
EUS endoscopic ultrasonography, AJCC American Joint Committee on Cancer, CT computed tomography, ECOG Eastern Cooperative Oncology Group, ASA American Society of Anesthesiologists, BMI body mass index