Rectal Cancer
Conditions
Keywords
Low rectal cancer, Robotic, Laparoscopic, Abdominoperineal resection
Brief summary
In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.
Detailed description
Patients will be eligible for inclusion if their primary tumors is low rectal cancer. Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.
Interventions
PROCEDURERobotic-assisted resection.
Robotic-assisted abdominoperineal resection.
PROCEDURELaparoscopic resection
Laparoscopic abdominoperineal resection
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven rectal adenocarcinoma * Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination * No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc * Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI * 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 robot-assisted and laparoscopic surgery * American Society of Anesthesiologists (ASA) class I - III * No other preoperative treatment except neoadjuvant chemoradiotherapy * Informed consent
Exclusion criteria
* Tumors assessed as cT1N0 and suitable for local excision * Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery * More than one colorectal tumor * Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease * Schedules need for other synchronous colon surgery * Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III) * Pregnancy or lactation * Patients and/or family members can not understand and accept this study * Patients received chemoradiotherapy or other anti-tumor therapy before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | 30 days post operatively | postoperative complications related to operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operative mortality | 30 days post operatively | death occurred 30 days after operation |
| disease-free survival | 3 years | disease-free survival rate at 3 years after operation |
| overall survival | 3 and 5 years | overall survival rate at 3 and 5 years after operation |
| locoregional recurrence rate | 3 and 5 years | local recurrence rate at 3 and 5 years after operation |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of retrieved lymph nodes | 10 days post operatively | It will be reported according to the post-operative pathology. |
| postoperative hospital stay | 30 days post operatively | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge. |
| operative time | Day 1 | Time from cutting the skin to suturing the incision during the surgery, recorded in minute |
| self reported sexual function for male patients | at postoperative 3, 6 and 1 2 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 1 2 months | This section is assessed using a self-rating scale Female Sexual Function Index (FSFI). |
| self reported bladder function | at postoperative 3, 6 and 1 2 months | This section is assessed using a self-rating scale International prostate symptom score (IPSS) |
| rate of conversion to open surgery | Day 1 | The rate of patients actually receiving open surgery in robotic or laparoscopic surgery groups. |
| 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 | 10 days post operatively | The circumferential 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. |
| proximal/distal resection margin | 10 days post operatively | 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