A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer

NCT ID: NCT01985698

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2019-12-31

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.

Conditions

Rectal Cancer

Study Design

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

Study Groups

Robotic-assisted resection

patients with low rectal cancer receiving robotic-assisted abdominoperineal resection.

Group Type: EXPERIMENTAL

Robotic-assisted resection.

Intervention Type: PROCEDURE

Robotic-assisted abdominoperineal resection.

Laparoscopic resection

patients with low rectal cancer receiving laparoscopic abdominoperineal resection.

Group Type: ACTIVE_COMPARATOR

Laparoscopic resection

Intervention Type: PROCEDURE

Laparoscopic abdominoperineal resection

Interventions

Robotic-assisted resection.

Robotic-assisted abdominoperineal resection.

Intervention Type: PROCEDURE

Laparoscopic resection

Laparoscopic abdominoperineal resection

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianmin Xu, MD

Role: STUDY_CHAIR

Fudan University

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

Feng Q, Tang W, Zhang Z, Wei Y, Ren L, Chang W, Zhu D, Liang F, He G, Xu J. Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial. J Surg Oncol. 2022 Dec;126(8):1481-1493. doi: 10.1002/jso.27076. Epub 2022 Aug 29.

Reference Type: DERIVED

PMID: 36036889 (View on PubMed)

Other Identifiers

RLAPR

Identifier Type: -

Identifier Source: org_study_id