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Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL)

Primary Purpose

Rectal Carcinoma

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robot-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 Carcinoma focused on measuring Minimally Invasive Surgical Procedures, Robotic Surgical Procedures, Laparoscopic Surgical Procedures, Rectal Cancer, Intraoperative Complications, Postoperative Complications, Recovery of Function, Recurrence, Disease Progression, Survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class I - III;
  • Histologically proved rectal adenocarcinoma;
  • Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
  • Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
  • No evidence of distant metastases;
  • 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 robotic and laparoscopic surgery;
  • Informed consent.

Exclusion Criteria:

  • Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy;
  • Tumors assessed as cT1N0 and suitable for local excision;
  • Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery;
  • Multiple colorectal tumors or other schedules needing for synchronous colon surgery;
  • Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
  • Co-existent inflammatory bowel disease;
  • Pregnancy or lactation;
  • Patients received treatment other than preoperative radio- or chemoradiotherapy.

Sites / Locations

  • Chinese PLA General Hospital
  • The Southwest Hospital of Army Medical University
  • The First Affiliated Hospital of Zhengzhou University
  • The First Affiliated Hospital of Nanchang University
  • Jilin Cancer Hospital
  • Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)
  • The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)
  • The Affiliated Hospital of Qingdao University
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Zhongshan Hospital, Fudan University
  • The First Affiliated Hospital of Naval Medical University (Changhai Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot-assisted surgery

Laparoscopic surgery

Arm Description

Patients undergo robot-assisted resections.

Patients undergo laparoscopic resections.

Outcomes

Primary Outcome Measures

Locoregional recurrence rate
The proportion of patients with any cancer recurrence in the pelvic or perineal area

Secondary Outcome Measures

Circumferential resection margin positive rate
The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor
Postoperative complication rate
The proportion of patients with any complications occurred within 30 days after surgery
Overall survival time
Time from surgery to death
Disease-free survival time
Time from surgery to any recurrence, metastases or death
Operative time
Time from making skin incision to suturing the incision during the surgery
Rate of conversion to open surgery
The proportion of patients with the use of a laparotomy incision for any part of the TME procedure or lymph nodes dissection during the surgery
Estimated blood loss
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
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.
Number of retrieved lymph nodes
The number of lymph node found from the surgical specimen
Postoperative hospital stay
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.
Self reported bladder function
This section is assessed using a self-rating scale "International prostate symptom score" (IPSS).
Self reported sexual function for male patients
This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).
Self reported sexual function for female patients
This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).

Full Information

First Posted
March 7, 2016
Last Updated
March 20, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02817126
Brief Title
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer
Acronym
REAL
Official Title
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 10, 2016 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.
Detailed Description
Laparoscopic surgery as the treatment for colon cancer has been widely recognized. But its use for rectal cancer is still controversial. Previous trials have shown that although the long-term survival outcomes were similar, laparoscopic surgery did not reach the non-inferiority in terms of local tumor radical resection, compared with open surgery. Robotic techniques are considered to improve the quality of surgery with three-dimensional vision, stable camera platform and flexible robotic arms. Meta-analyses have shown that compared with laparoscopic surgery, robotic surgery could improve surgical quality in terms of open conversion, circumferential resection margin, postoperative complications, postoperative recovery, and quality of life, with similar long-term survival. However, these evidences mainly came from retrospective studies and small-scale randomized controlled trials with low quality. There still needs high-quality clinical trials to confirm the advantages of robotic surgery for rectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Carcinoma
Keywords
Minimally Invasive Surgical Procedures, Robotic Surgical Procedures, Laparoscopic Surgical Procedures, Rectal Cancer, Intraoperative Complications, Postoperative Complications, Recovery of Function, Recurrence, Disease Progression, Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted surgery
Arm Type
Experimental
Arm Description
Patients undergo robot-assisted resections.
Arm Title
Laparoscopic surgery
Arm Type
Active Comparator
Arm Description
Patients undergo laparoscopic resections.
Intervention Type
Procedure
Intervention Name(s)
Robot-assisted resection
Intervention Description
Arm I: Robot-assisted resection using da vinci system.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic resection
Intervention Description
Arm II: Traditional laparoscopic resection.
Primary Outcome Measure Information:
Title
Locoregional recurrence rate
Description
The proportion of patients with any cancer recurrence in the pelvic or perineal area
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
Circumferential resection margin positive rate
Description
The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor
Time Frame
1 week after surgery
Title
Postoperative complication rate
Description
The proportion of patients with any complications occurred within 30 days after surgery
Time Frame
30 days after surgery
Title
Overall survival time
Description
Time from surgery to death
Time Frame
3 years after surgery
Title
Disease-free survival time
Description
Time from surgery to any recurrence, metastases or death
Time Frame
3 years after surgery
Title
Operative time
Description
Time from making skin incision to suturing the incision during the surgery
Time Frame
Day 1
Title
Rate of conversion to open surgery
Description
The proportion of patients with the use of a laparotomy incision for any part of the TME procedure or lymph nodes dissection during the surgery
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
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
1 week after surgery
Title
Number of retrieved lymph nodes
Description
The number of lymph node found from the surgical specimen
Time Frame
1 week after surgery
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 after surgery
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 12 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 12 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 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) class I - III; Histologically proved rectal adenocarcinoma; Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy; Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI; No evidence of distant metastases; 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 robotic and laparoscopic surgery; Informed consent. Exclusion Criteria: Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy; Tumors assessed as cT1N0 and suitable for local excision; Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery; Multiple colorectal tumors or other schedules needing for synchronous colon surgery; Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.); Co-existent inflammatory bowel disease; Pregnancy or lactation; Patients received treatment other than preoperative radio- or chemoradiotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, Ph.D., M.D.
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100141
Country
China
Facility Name
The Southwest Hospital of Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
671014
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
123005
Country
China
Facility Name
The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital of Naval Medical University (Changhai Hospital)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36087608
Citation
Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Liang F, He G, Wei Y, Xu J; REAL Study Group. Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004. doi: 10.1016/S2468-1253(22)00248-5. Epub 2022 Sep 8.
Results Reference
derived

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Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer

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