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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robotic-assisted resection.
Laparoscopic resection
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Low rectal cancer, Robotic, Laparoscopic, Abdominoperineal resection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic-assisted resection

Laparoscopic resection

Arm Description

patients with low rectal cancer receiving robotic-assisted abdominoperineal resection.

patients with low rectal cancer receiving laparoscopic abdominoperineal resection.

Outcomes

Primary Outcome Measures

postoperative complications
postoperative complications related to operation

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2013
Last Updated
March 6, 2021
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01985698
Brief Title
A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer
Acronym
RLAPR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Low rectal cancer, Robotic, Laparoscopic, Abdominoperineal resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic-assisted resection
Arm Type
Experimental
Arm Description
patients with low rectal cancer receiving robotic-assisted abdominoperineal resection.
Arm Title
Laparoscopic resection
Arm Type
Active Comparator
Arm Description
patients with low rectal cancer receiving laparoscopic abdominoperineal resection.
Intervention Type
Procedure
Intervention Name(s)
Robotic-assisted resection.
Intervention Description
Robotic-assisted abdominoperineal resection.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic resection
Intervention Description
Laparoscopic abdominoperineal resection
Primary Outcome Measure Information:
Title
postoperative complications
Description
postoperative complications related to operation
Time Frame
30 days post operatively
Secondary Outcome Measure Information:
Title
operative mortality
Description
death occurred 30 days after operation
Time Frame
30 days post operatively
Title
disease-free survival
Description
disease-free survival rate at 3 years after operation
Time Frame
3 years
Title
overall survival
Description
overall survival rate at 3 and 5 years after operation
Time Frame
3 and 5 years
Title
locoregional recurrence rate
Description
local recurrence rate at 3 and 5 years after operation
Time Frame
3 and 5 years
Other Pre-specified Outcome Measures:
Title
operative time
Description
Time from cutting the skin to suturing the incision during the surgery, recorded in minute
Time Frame
Day 1
Title
rate of conversion to open surgery
Description
The rate of patients actually receiving open surgery in robotic or laparoscopic surgery groups.
Time Frame
Day 1
Title
estimated blood loss
Description
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Time Frame
Day 1
Title
circumferential resection margin
Description
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.
Time Frame
10 days post operatively
Title
proximal/distal resection margin
Description
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.
Time Frame
10 days post operatively
Title
number of retrieved lymph nodes
Description
It will be reported according to the post-operative pathology.
Time Frame
10 days post operatively
Title
postoperative hospital stay
Description
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.
Time Frame
30 days post operatively
Title
self reported bladder function
Description
This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)
Time Frame
at postoperative 3, 6 and 1 2 months
Title
self reported sexual function for male patients
Description
This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).
Time Frame
at postoperative 3, 6 and 1 2 months
Title
self reported sexual function for female patients
Description
This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).
Time Frame
at postoperative 3, 6 and 1 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, MD
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36036889
Citation
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.
Results Reference
derived

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

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