Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer
- Conditions
- Rectal Carcinoma
- Interventions
- Procedure: Robot-assisted resectionProcedure: Laparoscopic resection
- Registration Number
- NCT02817126
- Lead Sponsor
- Fudan University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1240
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robot-assisted surgery Robot-assisted resection Patients undergo robot-assisted resections. Laparoscopic surgery Laparoscopic resection Patients undergo laparoscopic resections.
- Primary Outcome Measures
Name Time Method Locoregional recurrence rate 3 years after surgery The proportion of patients with any cancer recurrence in the pelvic or perineal area
- Secondary Outcome Measures
Name Time Method 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
Disease-free survival time 3 years after surgery Time from surgery to any recurrence, metastases or death
Overall survival time 3 years after surgery Time from surgery to death
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
Operative time Day 1 Time from making skin incision to suturing the incision 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.
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 female patients At postoperative 3, 6 and 12 months This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).
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 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).
Trial Locations
- Locations (11)
Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)
🇨🇳Shenyang, Liaoning, China
The Southwest Hospital of Army Medical University
🇨🇳Chongqing, Chongqing, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
The First Affiliated Hospital of Naval Medical University (Changhai Hospital)
🇨🇳Shanghai, Shanghai, China
The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)
🇨🇳Jinan, Shandong, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China