Clinical trial NCT02817126: Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer
Official title: Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 1240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Locoregional recurrence rate
timeFrame: 3 years after surgery
Secondary outcomes:
measure: Circumferential resection margin positive rate
timeFrame: 1 week after surgery
measure: Postoperative complication rate
timeFrame: 30 days after surgery
measure: Overall survival time
timeFrame: 3 years after surgery
measure: Disease-free survival time
timeFrame: 3 years after surgery
measure: Operative time
timeFrame: Day 1
measure: Rate of conversion to open surgery
timeFrame: Day 1
measure: Estimated blood loss
timeFrame: Day 1
measure: Proximal/distal resection margin
timeFrame: 1 week after surgery
measure: Number of retrieved lymph nodes
timeFrame: 1 week after surgery
measure: Postoperative hospital stay
timeFrame: 30 days after surgery
measure: Self reported bladder function
timeFrame: At postoperative 3, 6 and 12 months
measure: Self reported sexual function for male patients
timeFrame: At postoperative 3, 6 and 12 months
measure: Self reported sexual function for female patients
timeFrame: At postoperative 3, 6 and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: The Southwest Hospital of Army Medical University
state: Chongqing
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)
state: Liaoning
city: Jinan
country: China
facility: The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: The First Affiliated Hospital of Naval Medical University (Changhai Hospital)
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jianmin Xu, Ph.D., M.D.
role: STUDY_CHAIR
References:
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.