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

A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Robotic-assisted resection.; Procedure: Laparoscopic resection

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 Type: Interventional
• Enrollment (Actual): 347
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic-assisted resection; patients with low rectal cancer receiving robotic-assisted abdominoperineal resection.	Procedure: Robotic-assisted resection.; Robotic-assisted abdominoperineal resection.
Active Comparator: Laparoscopic resection; patients with low rectal cancer receiving laparoscopic abdominoperineal resection.	Procedure: Laparoscopic resection; Laparoscopic abdominoperineal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	postoperative complications related to operation	30 days post operatively

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimated blood loss	Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.	Day 1
postoperative hospital stay	The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.	30 days post operatively
self reported bladder function	This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)	at postoperative 3, 6 and 1 2 months
self reported sexual function for female patients	This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).	at postoperative 3, 6 and 1 2 months
operative time	Time from cutting the skin to suturing the incision during the surgery, recorded in minute	Day 1
rate of conversion to open surgery	The rate of patients actually receiving open surgery in robotic or laparoscopic surgery groups.	Day 1
circumferential resection margin	The circumferential margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.	10 days post operatively
proximal/distal resection margin	The proximal/distal resection margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.	10 days post operatively
number of retrieved lymph nodes	It will be reported according to the post-operative pathology.	10 days post operatively
self reported sexual function for male patients	This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).	at postoperative 3, 6 and 1 2 months

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Chair: Jianmin Xu, MD, Fudan University

Publications and helpful links

General Publications

• Feng Q, Tang W, Zhang Z, Wei Y, Ren L, Chang W, Zhu D, Liang F, He G, Xu J. Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial. J Surg Oncol. 2022 Dec;126(8):1481-1493. doi: 10.1002/jso.27076. Epub 2022 Aug 29.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: November 9, 2013
• First Submitted That Met QC Criteria: November 9, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Laparoscopic; Robotic; Abdominoperineal resection; Low rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: RLAPR