Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial

Conditions
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Rectal Carcinoma

Intervention / Treatment
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* Procedure: Robot-assisted resection
* Procedure: Laparoscopic resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted surgery<br>Patients undergo robot-assisted resections. | Procedure: Robot-assisted resection<br>* Arm I: Robot-assisted resection using da vinci system.<br>|
| Active Comparator: Laparoscopic surgery<br>Patients undergo laparoscopic resections. | Procedure: Laparoscopic resection<br>* Arm II: Traditional laparoscopic resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional recurrence rate | The proportion of patients with any cancer recurrence in the pelvic or perineal area | 3 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumferential resection margin positive rate | The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor | 1 week after surgery | 
| Postoperative complication rate | The proportion of patients with any complications occurred within 30 days after surgery | 30 days after surgery | 
| Overall survival time | Time from surgery to death | 3 years after surgery | 
| Disease-free survival time | Time from surgery to any recurrence, metastases or death | 3 years after surgery | 
| Operative time | Time from making skin incision to suturing the incision during the surgery | Day 1 | 
| Rate of conversion to open surgery | 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 | Day 1 | 
| Estimated blood loss | Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation. | Day 1 | 
| Proximal/distal resection margin | 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. | 1 week after surgery | 
| Number of retrieved lymph nodes | The number of lymph node found from the surgical specimen | 1 week after surgery | 
| Postoperative hospital stay | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge. | 30 days after surgery | 
| Self reported bladder function | This section is assessed using a self-rating scale International prostate symptom score (IPSS). | At postoperative 3, 6 and 12 months | 
| Self reported sexual function for male patients | This section is assessed using a self-rating scale International Index of Erectile Function (IIEF-5). | At postoperative 3, 6 and 12 months | 
| Self reported sexual function for female patients | This section is assessed using a self-rating scale Female Sexual Function Index (FSFI). | At postoperative 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Surgical Procedures, Robotic Surgical Procedures, Laparoscopic Surgical Procedures, Rectal Cancer, Intraoperative Complications, Postoperative Complications, Recovery of Function, Recurrence, Disease Progression, Survival