Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum

Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum : A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial

The purpose of this study is to evaluate the safety and oncological feasibility of laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.

Inclusion Criteria:

• histologically proven rectal adenocarcinoma
• inferior edge of the tumor located within 5 cm from the dentate line as determined by rigid proctoscopy
• diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision
• T3-4a,N0 or T1-4a,N1-2 treated with neoadjuvant chemoradiotherapy
• no evidence of distant metastases
• tumor size <6cm
• sufficient organ function
• no contraindication to laparoscopic surgery
• without other malignancies in medical history

Exclusion Criteria:

• concurrent or previous diagnosis of invasive cancer within 5 years
• locally advanced cancers requiring en bloc multivisceral resection
• intestinal obstruction
• intestinal perforation
• history of colorectal surgery
• American Society of Anesthesiologists(ASA) class 4 or 5
• pregnant or breast-feeding women
• history of mental disorder
• participation in another rectal cancer clinical trial relating to surgical technique