Rectal CancerPhase 3NCT01130233
Randomized Trial on Robotic Assisted Resection for Rectal Cancer
A Phase 3 study testing robotic assisted rectal resection and laparoscopic rectal resection in people with Rectal Cancer and Adenocarcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma
- What is being tested?
- robotic assisted rectal resection and laparoscopic rectal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2009to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Wai Lun LAW, MBBS, MS, +852 22554763, lawwl@hkucc.hku.hk
Wai Lun Law, MBBS, MS
About this study
Official title: Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer
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.
Read the 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
- Conditions
- Rectal Cancer, Adenocarcinoma
- Being tested
- robotic assisted rectal resection, laparoscopic rectal resection
- Keywords
- rectal cancer
- Medical subject headings
- Rectal Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic assisted rectal resectionProcedure or surgery
robotic assisted rectal resection
laparoscopic rectal resectionProcedure or surgery
laparoscopic rectal resection
| Study group | Role | What they receive |
|---|---|---|
| robotic | Experimental | robotic assisted rectal resection Receives: Procedure: robotic assisted rectal resection |
| laparoscopic | Active comparator | laparoscopic rectal resection Receives: Procedure: laparoscopic rectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder function
Urodynamic Questionnaire
Measured: one year
Secondary outcomes (2)
tumor status
recurrence and survival
Measured: One year
Quality of life
Questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Wai Lun Law, MBBS, MS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130233
- Sponsor's protocol ID
- UW 09-132
- Status last verified
- May 2010
- First submitted
- 24 May 2010
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT01130233
- Acronym / sponsor ID
- UW 09-132
- Conditions
- Rectal Cancer, Adenocarcinoma
- Keywords
- rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic | Experimental | Procedure: robotic assisted rectal resectionrobotic assisted rectal resection |
| laparoscopic | Active comparator | Procedure: laparoscopic rectal resectionlaparoscopic rectal resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic assisted rectal resectionrobotic assisted rectal resection | Procedure or surgery | robotic |
| laparoscopic rectal resectionlaparoscopic rectal resection | Procedure or surgery | laparoscopic |
Primary outcome
Bladder function
Time frame: one year
Urodynamic Questionnaire
2 secondary outcomes
tumor status
Time frame: One year
Quality of life
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Lun Law, MBBS, MS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing robotic assisted rectal resection and laparoscopic rectal resection in people with Rectal Cancer and Adenocarcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wai Lun Law, MBBS, MS (+852 22554763, lawwl@hkucc.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder function (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2010; AzTrials last refreshed its copy on 31 Oct 2026.