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Table 1 Inclusion, exclusion, and withdrawal criteria

From: A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial

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

 
  1. 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