Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- The University of Hong Kong
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Bladder function
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
robotic
robotic assisted rectal resection
Intervention: robotic assisted rectal resection (Procedure)
laparoscopic
laparoscopic rectal resection
Intervention: laparoscopic rectal resection (Procedure)
Outcomes
Primary Outcomes
Bladder function
Time Frame: one year
Urodynamic Questionnaire
Secondary Outcomes
- tumor status(One year)
- Quality of life(one year)