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

Sponsor

Fudan University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02817126

Collaborator

(none)

1,240

Enrollment

Locations

Arms

89.7

Anticipated Duration (Months)

112.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Carcinoma	Procedure: Robot-assisted resection Procedure: Laparoscopic resection	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial

Actual Study Start Date :

Jul 10, 2016

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot-assisted surgery Patients undergo robot-assisted resections.	Procedure: Robot-assisted resection Arm I: Robot-assisted resection using da vinci system.
Active Comparator: Laparoscopic surgery Patients undergo laparoscopic resections.	Procedure: Laparoscopic resection Arm II: Traditional laparoscopic resection.

Arm

Intervention/Treatment

Experimental: Robot-assisted surgery

Patients undergo robot-assisted resections.

Procedure: Robot-assisted resection

Arm I: Robot-assisted resection using da vinci system.

Active Comparator: Laparoscopic surgery

Patients undergo laparoscopic resections.

Procedure: Laparoscopic resection

Arm II: Traditional laparoscopic resection.

Outcome Measures

Primary Outcome Measures

Locoregional recurrence rate [3 years after surgery]
The proportion of patients with any cancer recurrence in the pelvic or perineal area

Secondary Outcome Measures

Circumferential resection margin positive rate [1 week after surgery]
The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor
Postoperative complication rate [30 days after surgery]
The proportion of patients with any complications occurred within 30 days after surgery
Overall survival time [3 years after surgery]
Time from surgery to death
Disease-free survival time [3 years after surgery]
Time from surgery to any recurrence, metastases or death
Operative time [Day 1]
Time from making skin incision to suturing the incision during the surgery
Rate of conversion to open surgery [Day 1]
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 [Day 1]
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Proximal/distal resection margin [1 week after surgery]
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 [1 week after surgery]
The number of lymph node found from the surgical specimen
Postoperative hospital stay [30 days after surgery]
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.
Self reported bladder function [At postoperative 3, 6 and 12 months]
This section is assessed using a self-rating scale "International prostate symptom score" (IPSS).
Self reported sexual function for male patients [At postoperative 3, 6 and 12 months]
This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).
Self reported sexual function for female patients [At postoperative 3, 6 and 12 months]
This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China	100141
2	The Southwest Hospital of Army Medical University	Chongqing	Chongqing	China	671014
3	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
4	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006
5	Jilin Cancer Hospital	Changchun	Jilin	China	130012
6	Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)	Shenyang	Liaoning	China	123005
7	The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)	Jinan	Shandong	China	250031
8	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China	266003
9	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200020
10	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032
11	The First Affiliated Hospital of Naval Medical University (Changhai Hospital)	Shanghai	Shanghai	China	200438