Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Case Comprehensive Cancer Center
With
PRIMARY OBJECTIVES: I. To evaluate pain and analgesic requirement of R-LESS RP compared to standard RALP. SECONDARY OBJECTIVES: I. Time to oral intake. II. Time to resume ambulation. III. Hospital stay, counted in whole days from the day of surgery to the day of discharge. IV. Perioperative parameters, including: operative time (defined as time elapsed from skin incision to placement of the final skin suture); estimated blood loss; additional ports; conversion to standard RALP (in R-LESS RP patients), or laparoscopic, or open surgery; length of stay. V. Intraoperative complications. VI. Postoperative complications, recorded according to the Clavien classification. VII. Body image perception, measured using the body image questionnaire (BIQ). VIII. Scar evaluation (at suture removal and at 6 month) by using a validated assessment tool, the Patient and Observer Scar Assessment Scale. IX. Health related quality of life, measured as patients' perception of functioning, disability, and well-being related to the following eight concepts: physical functioning, role limitations caused by physical health problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health. X. Urinary continence, assessing the number of pads used daily. XI. Erectile Function, assessed by the International Index of Erectile Function (IIEF-5). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo standard RALP. ARM II: Patients undergo R-LESS RP. After completion of study treatment, patients are followed up periodically for 1 year.
Age
35–72
Sex
MALE
Healthy volunteers
Not accepted
