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

Fudan University1,240 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,240

Conditions

Rectal Carcinoma

Interventions

Robot-assisted resectionPROCEDURE

Arm I: Robot-assisted resection using da vinci system.

Laparoscopic resectionPROCEDURE

Arm II: Traditional laparoscopic resection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (11)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

The Southwest Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Zhengzhou University

Outcomes

Primary Outcomes

Locoregional recurrence rate

The proportion of patients with any cancer recurrence in the pelvic or perineal area

Time frame: 3 years after surgery

Secondary Outcomes

Circumferential resection margin positive rate

The proportion of patients with circumferential resection margin ≤ 1 mm from the tumor

Time frame: 1 week after surgery

Postoperative complication rate

The proportion of patients with any complications occurred within 30 days after surgery

Time frame: 30 days after surgery

Overall survival time

Time from surgery to death

Time frame: 3 years after surgery

Disease-free survival time

Time from surgery to any recurrence, metastases or death

Time frame: 3 years after surgery

Operative time

Time from making skin incision to suturing the incision during the surgery

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.