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

NCT ID: NCT02817126

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-10
• Study Completion Date: 2023-12-31

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.

Conditions

Rectal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot-assisted surgery

Patients undergo robot-assisted resections.

Group Type: EXPERIMENTAL

Robot-assisted resection

Intervention Type: PROCEDURE

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

Laparoscopic surgery

Patients undergo laparoscopic resections.

Group Type: ACTIVE_COMPARATOR

Laparoscopic resection

Intervention Type: PROCEDURE

Arm II: Traditional laparoscopic resection.

Interventions

Robot-assisted resection

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

Intervention Type: PROCEDURE

Laparoscopic resection

Arm II: Traditional laparoscopic resection.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Head of Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianmin Xu, Ph.D., M.D.

Role: STUDY_CHAIR

Fudan University

Locations

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

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Chinese PLA General Hospital of Northern Theatre Command (former Shenyang Military General Hospital)

Shenyang, Liaoning, China

The 960th Hospital of Chinese PLA Joint Logistic Support Force (former Jinan Military General Hospital)

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Naval Medical University (Changhai Hospital)

Shanghai, Shanghai Municipality, China

Countries

China

References

Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Wei Y, Liang F, He G, Xu J; REAL Study Group. Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial. JAMA. 2025 Jul 8;334(2):136-148. doi: 10.1001/jama.2025.8123.

Reference Type: DERIVED

PMID: 40455621 (View on PubMed)

Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, Zhang W, Zhao R, Zhang C, Cheng L, Zhang X, Liang F, He G, Wei Y, Xu J; REAL Study Group. Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004. doi: 10.1016/S2468-1253(22)00248-5. Epub 2022 Sep 8.

Reference Type: DERIVED

PMID: 36087608 (View on PubMed)

Other Identifiers

REAL

Identifier Type: -

Identifier Source: org_study_id