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

Rectal Carcinoma Clinical Trial

— REAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02817126
• Other study ID #: REAL
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 10, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1240
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Carcinoma
• Rectal Neoplasms

Intervention

Procedure:
• Robot-assisted resection
Arm I: Robot-assisted resection using da vinci system.
• Laparoscopic resection
Arm II: Traditional laparoscopic resection.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	The Southwest Hospital of Army Medical University	Chongqing	Chongqing
China	The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Naval Medical University (Changhai Hospital)	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)	Shenyang	Liaoning
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional recurrence rate	The proportion of patients with any cancer recurrence in the pelvic or perineal area	3 years after surgery
Secondary	Circumferential resection margin positive rate	The proportion of patients with circumferential resection margin = 1 mm from the tumor	1 week after surgery
Secondary	Postoperative complication rate	The proportion of patients with any complications occurred within 30 days after surgery	30 days after surgery
Secondary	Overall survival time	Time from surgery to death	3 years after surgery
Secondary	Disease-free survival time	Time from surgery to any recurrence, metastases or death	3 years after surgery
Secondary	Operative time	Time from making skin incision to suturing the incision during the surgery	Day 1
Secondary	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	Day 1
Secondary	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
Secondary	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.	1 week after surgery
Secondary	Number of retrieved lymph nodes	The number of lymph node found from the surgical specimen	1 week after surgery
Secondary	Postoperative hospital stay	The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.	30 days after surgery
Secondary	Self reported bladder function	This section is assessed using a self-rating scale "International prostate symptom score" (IPSS).	At postoperative 3, 6 and 12 months
Secondary	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 12 months
Secondary	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 12 months