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

Fudan University

Status

Unknown

Conditions

Rectal Carcinoma

Treatments

Procedure: Robot-assisted resection

Procedure: Laparoscopic resection

Study type

Interventional

Funder types

Other

Identifiers

NCT02817126

REAL

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,240 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.