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

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: Robotic-assisted resection.; Procedure: Laparoscopic resection

• Registration Number: NCT01985698
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-11-09
• Study First Submitted QC: 2013-11-09
• Study First Posted: 2013-11-15
• Study Start: 2013-12
• Primary Completion: 2016-12
• Study Completion: 2019-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-06
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic-assisted resection	Robotic-assisted resection.	patients with low rectal cancer receiving robotic-assisted abdominoperineal resection.
Laparoscopic resection	Laparoscopic resection	patients with low rectal cancer receiving laparoscopic abdominoperineal resection.

Primary Outcome Measures

Name	Time	Method
postoperative complications	30 days post operatively	postoperative complications related to operation

Secondary Outcome Measures

Name	Time	Method
operative mortality	30 days post operatively	death occurred 30 days after operation
locoregional recurrence rate	3 and 5 years	local recurrence rate at 3 and 5 years after operation
disease-free survival	3 years	disease-free survival rate at 3 years after operation
overall survival	3 and 5 years	overall survival rate at 3 and 5 years after operation

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China