Rectal Carcinoma
Conditions
Keywords
Minimally Invasive Surgical Procedures, Robotic Surgical Procedures, Laparoscopic Surgical Procedures, Rectal Cancer, Intraoperative Complications, Postoperative Complications, Recovery of Function, Recurrence, Disease Progression, Survival
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.
Interventions
PROCEDURERobot-assisted resection
Arm I: Robot-assisted resection using da vinci system.
PROCEDURELaparoscopic resection
Arm II: Traditional laparoscopic resection.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional recurrence rate | 3 years after surgery | The proportion of patients with any cancer recurrence in the pelvic or perineal area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complication rate | 30 days after surgery | The proportion of patients with any complications occurred within 30 days after surgery |
| Overall survival time | 3 years after surgery | Time from surgery to death |
| Disease-free survival time | 3 years after surgery | Time from surgery to any recurrence, metastases or death |
| Operative time | Day 1 | Time from making skin incision to suturing the incision during the surgery |
| 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 |
| 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. |
| Circumferential resection margin positive rate | 1 week after surgery | The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor |
| 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 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 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). |
| 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). |
| 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. |
Countries
China
Outcome results
None listed