Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL)
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|ClinicalTrials.gov Identifier: NCT02817126|
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : March 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Rectal Carcinoma||Procedure: Robot-assisted resection Procedure: Laparoscopic resection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Locoregional recurrence rate [ Time Frame: 3 years after surgery ]The proportion of patients with any cancer recurrence in the pelvic or perineal area
- Circumferential resection margin positive rate [ Time Frame: 1 week after surgery ]The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor
- Postoperative complication rate [ Time Frame: 30 days after surgery ]The proportion of patients with any complications occurred within 30 days after surgery
- Overall survival time [ Time Frame: 3 years after surgery ]Time from surgery to death
- Disease-free survival time [ Time Frame: 3 years after surgery ]Time from surgery to any recurrence, metastases or death
- Operative time [ Time Frame: Day 1 ]Time from making skin incision to suturing the incision during the surgery
- 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
- 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.
- 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.
- Number of retrieved lymph nodes [ Time Frame: 1 week after surgery ]The number of lymph node found from the surgical specimen
- 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.
- 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).
- 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).
- 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).
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817126
|Chinese PLA General Hospital|
|Beijing, Beijing, China, 100141|
|The Southwest Hospital of Army Medical University|
|Chongqing, Chongqing, China, 671014|
|The First Affiliated Hospital of Zhengzhou University|
|Zhengzhou, Henan, China, 450052|
|The First Affiliated Hospital of Nanchang University|
|Nanchang, Jiangxi, China, 330006|
|Jilin Cancer Hospital|
|Changchun, Jilin, China, 130012|
|Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)|
|Shenyang, Liaoning, China, 123005|
|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|
|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|
|Study Chair:||Jianmin Xu, Ph.D., M.D.||Fudan University|
|Responsible Party:||Xu jianmin, Head of Colorectal Surgery, Fudan University|
|Other Study ID Numbers:||
|First Posted:||June 29, 2016 Key Record Dates|
|Last Update Posted:||March 22, 2022|
|Last Verified:||March 2022|
Minimally Invasive Surgical Procedures
Robotic Surgical Procedures
Laparoscopic Surgical Procedures
Recovery of Function
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases