Rectal Cancer Clinical Trial
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.
Status | Recruiting |
Enrollment | 98 |
Est. completion date | December 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge 2. Age >18 years 3. Informed consent obtained 4. American Society of Anesthesiologist class 1-3 5. No contraindication to laparoscopic surgery 6. Acceptable operating risk Exclusion Criteria: 1. Locally advanced fixed tumor with the need for exenterative surgery 2. Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous 3. Multiple previous operations with the anticipation of dense peritoneal adhesions 4. No informed consent |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bladder function | Urodynamic Questionnaire | one year | No |
Secondary | tumor status | recurrence and survival | One year | No |
Secondary | Quality of life | Questionnaire | one year | No |
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