A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer (RLAPR)

Fudan University

Status

Completed

Conditions

Rectal Cancer

Treatments

Procedure: Laparoscopic resection

Procedure: Robotic-assisted resection.

Study type

Interventional

Funder types

Other

Identifiers

NCT01985698

RLAPR

Details and patient eligibility

About

In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.

Full description

Patients will be eligible for inclusion if their primary tumors is low rectal cancer.

Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.

Enrollment

347 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically proven rectal adenocarcinoma
Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination
No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc
Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI
No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
Suitable for both robot-assisted and laparoscopic surgery
American Society of Anesthesiologists (ASA) class I - III
No other preoperative treatment except neoadjuvant chemoradiotherapy
Informed consent

Exclusion criteria

Tumors assessed as cT1N0 and suitable for local excision
Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
More than one colorectal tumor
Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
Schedules need for other synchronous colon surgery
Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
Pregnancy or lactation
Patients and/or family members can not understand and accept this study
Patients received chemoradiotherapy or other anti-tumor therapy before surgery