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Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery

Primary Purpose

Recurrent Rectal Cancer, Stage I Rectal Cancer, Stage II Rectal Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

conventional laparoscopic surgery

robotic-assisted laparoscopic surgery

quality-of-life assessment

questionnaire administration

About this trial

This is an interventional treatment trial for Recurrent Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion

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

Exclusion

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients undergo standard conventional laparoscopic resection.

Patients undergo robotic-assisted laparoscopic resection.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Circumferential resection margin positivity rate

Local recurrence rate

Intra-operative and post-operative complications

Operative mortality

Self reported bladder and sexual function

Health related quality of life

Disease free and overall survival

Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS)

Quality of the plane of surgery as assessed by central review of photographs

Health economics

Full Information

NCT ID

NCT01196000

First Posted

September 3, 2010

Last Updated

April 16, 2012

Sponsor

City of Hope Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01196000

Brief Title

Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery

Official Title

Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Withdrawn

Why Stopped

The study has never been opened to accrual at COH. Study to be closed at COH due to the lack of qualified robotic colorectal surgeons.

Study Start Date

December 2011 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

City of Hope Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

OBJECTIVES: I. To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal cancer resection by means of a randomized, controlled trial. II. To assess technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation. III. To assess surgical accuracy and improved oncological outcome as determined by clear pathological resection margins. IV. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge to inform NHS and other service providers and decision-makers. V. To analyze disease-free and overall survival and local recurrence rates at 3-year follow-up. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo standard laparoscopic resection. ARM II: Patients undergo robotic-assisted laparoscopic resection. After completion of study treatment, patients are followed up at 1 month, 6 months, and then annually thereafter for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Rectal Cancer, Stage I Rectal Cancer, Stage II Rectal Cancer, Stage III Rectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Active Comparator

Arm Description

Patients undergo standard conventional laparoscopic resection.

Arm Title

Arm II

Arm Type

Experimental

Arm Description

Patients undergo robotic-assisted laparoscopic resection.

Intervention Type

Procedure

Intervention Name(s)

conventional laparoscopic surgery

Other Intervention Name(s)

laparoscopy-assisted surgery, surgery, laparoscopic

Intervention Description

operation using conventional laparoscopic techniques

Intervention Type

Procedure

Intervention Name(s)

robotic-assisted laparoscopic surgery

Intervention Description

operation that involves use of laparoscopic assistance with robotic assistance

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

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

Time Frame

At completion of surgery

Secondary Outcome Measure Information:

Title

Circumferential resection margin positivity rate

Time Frame

At completion of pathology review

Title

Local recurrence rate

Time Frame

At 3 years

Title

Intra-operative and post-operative complications

Time Frame

At day 30 and 6 months

Title

Operative mortality

Time Frame

At day 30

Title

Self reported bladder and sexual function

Time Frame

At day 30 and 6 months

Title

Health related quality of life

Time Frame

At day 30 and 6 months

Title

Disease free and overall survival

Time Frame

At 3 years

Title

Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS)

Time Frame

Upon completion of GOALS assessment by an independent expert

Title

Quality of the plane of surgery as assessed by central review of photographs

Time Frame

At completion of the central review of photographs

Title

Health economics

Time Frame

At day 30 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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 Exclusion 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessio Pigazzi

Organizational Affiliation

City of Hope Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Laparoscopic Surgery or Robotic-Assisted Laparoscopic Surgery in Treating Patients With Rectal Cancer That Can Be Removed By Surgery

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