Randomized Trial on Robotic Assisted Resection for Rectal Cancer
Primary Purpose
Rectal Cancer, Adenocarcinoma
Status
Unknown status
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
robotic assisted rectal resection
laparoscopic rectal resection
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge
- Age >18 years
- Informed consent obtained
- American Society of Anesthesiologist class 1-3
- No contraindication to laparoscopic surgery
- Acceptable operating risk
Exclusion Criteria:
- Locally advanced fixed tumor with the need for exenterative surgery
- Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous
- Multiple previous operations with the anticipation of dense peritoneal adhesions
- No informed consent
Sites / Locations
- Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
robotic
laparoscopic
Arm Description
robotic assisted rectal resection
laparoscopic rectal resection
Outcomes
Primary Outcome Measures
Bladder function
Urodynamic Questionnaire
Secondary Outcome Measures
tumor status
recurrence and survival
Quality of life
Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01130233
Brief Title
Randomized Trial on Robotic Assisted Resection for Rectal Cancer
Official Title
Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery
This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer.
Detailed Description
This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer
The primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial.
The secondary outcome measures include
The operative outcome in terms of the complication rate, hospital stay and reoperation of the two groups;
The quality of life of the patients and the cost of the two groups
The quality of the resected specimens
The local recurrence rates at two years after the surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Adenocarcinoma
Keywords
rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robotic
Arm Type
Experimental
Arm Description
robotic assisted rectal resection
Arm Title
laparoscopic
Arm Type
Active Comparator
Arm Description
laparoscopic rectal resection
Intervention Type
Procedure
Intervention Name(s)
robotic assisted rectal resection
Intervention Description
robotic assisted rectal resection
Intervention Type
Procedure
Intervention Name(s)
laparoscopic rectal resection
Intervention Description
laparoscopic rectal resection
Primary Outcome Measure Information:
Title
Bladder function
Description
Urodynamic Questionnaire
Time Frame
one year
Secondary Outcome Measure Information:
Title
tumor status
Description
recurrence and survival
Time Frame
One year
Title
Quality of life
Description
Questionnaire
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge
Age >18 years
Informed consent obtained
American Society of Anesthesiologist class 1-3
No contraindication to laparoscopic surgery
Acceptable operating risk
Exclusion Criteria:
Locally advanced fixed tumor with the need for exenterative surgery
Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous
Multiple previous operations with the anticipation of dense peritoneal adhesions
No informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Lun Law, MBBS, MS
Phone
+852 22554763
Email
lawwl@hkucc.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Lun Law, MBBS, MS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wai Lun LAW, MBBS, MS
Phone
+852 22554763
Email
lawwl@hkucc.hku.hk
First Name & Middle Initial & Last Name & Degree
Wai Lun Law, MBBS, MS
12. IPD Sharing Statement
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Randomized Trial on Robotic Assisted Resection for Rectal Cancer
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