NCT01196000

Brief Summary

RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer. PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see how well it works compared to laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

April 17, 2012

Status Verified

April 1, 2012

Enrollment Period

1.6 years

First QC Date

September 3, 2010

Last Update Submit

April 16, 2012

Conditions

Recurrent Rectal CancerStage I Rectal CancerStage II Rectal CancerStage III Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of conversion to open surgery as an indicator of surgical technical difficulty

    At completion of surgery

Secondary Outcomes (10)

  • Circumferential resection margin positivity rate

    At completion of pathology review

  • Local recurrence rate

    At 3 years

  • Intra-operative and post-operative complications

    At day 30 and 6 months

  • Operative mortality

    At day 30

  • Self reported bladder and sexual function

    At day 30 and 6 months

  • +5 more secondary outcomes

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients undergo standard conventional laparoscopic resection.

Procedure: conventional laparoscopic surgeryProcedure: quality-of-life assessmentOther: questionnaire administration

Arm II

EXPERIMENTAL

Patients undergo robotic-assisted laparoscopic resection.

Procedure: robotic-assisted laparoscopic surgeryProcedure: quality-of-life assessmentOther: questionnaire administration

Interventions

conventional laparoscopic surgeryPROCEDURE

operation using conventional laparoscopic techniques

Also known as: laparoscopy-assisted surgery, surgery, laparoscopic
Arm I
robotic-assisted laparoscopic surgeryPROCEDURE

operation that involves use of laparoscopic assistance with robotic assistance

Arm II
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm IArm II
questionnaire administrationOTHER

Ancillary studies

Arm IArm II

Eligibility Criteria

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

You may qualify if:

  • Able to provide written informed consent
  • Diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged T1-3, N0-2, M0 by CT and MRI or transrectal ultrasound)
  • Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
  • Fit for robotic-assisted or standard laparoscopic rectal resection
  • ASA =\< 3
  • Capable of completing required questionnaires at time of consent

You may not qualify if:

  • Benign lesions of the rectum
  • Cancers of the anal canal
  • Locally advanced cancers not amenable to curative surgery
  • Locally advanced cancers requiring en bloc multi-visceral resection
  • Synchronous colorectal tumours requiring multi-segment surgical resection
  • Co-existent inflammatory bowel disease
  • Clinical or radiological evidence of metastatic spread
  • Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable; for other cases please discuss with Chief Investigator via CTRU)
  • History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
  • Pregnancy
  • Participation in another rectal cancer clinical trial relating to surgical technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Alessio Pigazzi

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 8, 2010

Study Start

December 1, 2011

Primary Completion

July 1, 2013

Last Updated

April 17, 2012

Record last verified: 2012-04