NCT01985698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

November 9, 2013

Last Update Submit

March 6, 2021

Conditions

Rectal Cancer

Keywords

Low rectal cancerRoboticLaparoscopicAbdominoperineal resection

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    postoperative complications related to operation

    30 days post operatively

Secondary Outcomes (4)

  • operative mortality

    30 days post operatively

  • disease-free survival

    3 years

  • overall survival

    3 and 5 years

  • locoregional recurrence rate

    3 and 5 years

Other Outcomes (10)

  • operative time

    Day 1

  • rate of conversion to open surgery

    Day 1

  • estimated blood loss

    Day 1

  • +7 more other outcomes

Study Arms (2)

Robotic-assisted resection

EXPERIMENTAL

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

Procedure: Robotic-assisted resection.

Laparoscopic resection

ACTIVE COMPARATOR

patients with low rectal cancer receiving laparoscopic abdominoperineal resection.

Procedure: Laparoscopic resection

Interventions

Robotic-assisted resection.PROCEDURE

Robotic-assisted abdominoperineal resection.

Robotic-assisted resection
Laparoscopic resectionPROCEDURE

Laparoscopic abdominoperineal resection

Laparoscopic resection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • 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.

    PMID: 36036889DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jianmin Xu, MD

    Fudan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 9, 2013

First Posted

November 15, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2019

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations

CN(1)