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

• ClinicalTrials.gov Identifier: NCT02817126
• Recruitment Status: Active, not recruiting
• First Posted: June 29, 2016
• Last Update Posted: March 22, 2022
• Sponsor: Fudan University
• Information provided by (Responsible Party): Xu jianmin, Fudan University

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	Not Applicable

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 (Clinical Trial)
• 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: July 10, 2016
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Beijing

Chinese PLA General Hospital

Beijing, Beijing, China, 100141

China, Chongqing

The Southwest Hospital of Army Medical University

Chongqing, Chongqing, China, 671014

China, Henan

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

China, Jiangxi

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

China, Jilin

Jilin Cancer Hospital

Changchun, Jilin, China, 130012

China, Liaoning

Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)

Shenyang, Liaoning, China, 123005

China, Shandong

The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)

Jinan, Shandong, China, 250031

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266003

China, Shanghai

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai, China, 200020

Zhongshan Hospital, Fudan University

Shanghai, Shanghai, China, 200032

The First Affiliated Hospital of Naval Medical University (Changhai Hospital)

Shanghai, Shanghai, China, 200438

Sponsors and Collaborators

Fudan University

Investigators

• Study Chair: Jianmin Xu, Ph.D., M.D.; Fudan University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Xu jianmin, Head of Colorectal Surgery, Fudan University
• ClinicalTrials.gov Identifier: NCT02817126
• Other Study ID Numbers: REAL
• First Posted: June 29, 2016
• Last Update Posted: March 22, 2022
• Last Verified: March 2022

Keywords provided by Xu jianmin, Fudan University:

Minimally Invasive Surgical Procedures; Robotic Surgical Procedures; Laparoscopic Surgical Procedures; Rectal Cancer; Intraoperative Complications; Postoperative Complications; Recovery of Function; Recurrence; Disease Progression; Survival

Additional relevant MeSH terms:

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases