Study Comparing Conventional vs. Robotic-assisted Laparoscopic Hysterectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00485355|
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : February 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids, Menorrhagia, Endometriosis||Procedure: conventional laparoscopic hysterectomy Procedure: robotic assisted laparoscopic hysterectomy||Not Applicable|
Compared to abdominal hysterectomy, the advantages of laparoscopic hysterectomy are decreased postoperative intravenous analgesia requirements, shorter length of hospital stay, quicker return to work and daily activities. Longer operating times have been shown to be offset by shorter hospital stays, with similar hospital costs overall. Compared to abdominal hysterectomy, laparoscopic hysterectomy is associated with less blood loss, fewer abdominal wall infections, or febrile episodes. The increased visualization allows for concomitant evaluation and excision of adhesions or endometriosis, as well as facilitating oophorectomy.
Robotic systems were developed in order to facilitate laparoscopy by more ergonomic movements that are easier to perform and more precise. The da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) has endowrist instruments that have seven degrees of movement and mimic the human wrist. It can also filter out tremors and other unintentional hand motions that may result from prolonged holding of instruments. The surgeon seated at a console commands the laparoscope and two laparoscopic surgical instruments.
In the literature, several case series have described the use of robotic-assisted hysterectomy. Two of these series included patients that were undergoing surgery for suspected malignancy, and hence has a different patient population that we are going to enroll.Overall these studies have demonstrated the feasibility of using robot-enhanced technology in order to perform hysterectomy in series of approximately 10-20 patients, with a similar rate of complications compared to classical laparoscopy.
The objective of this study is to conduct a prospective randomized controlled trial of robotic assisted versus traditional hysterectomy in the treatment of patients who have benign indications for hysterectomy, e.g. menorrhagia, symptomatic fibroid uteri, etc. Our primary outcome is operative time from incision to either closure or, in the case of concomitant prolapse or incontinence procedures, the completion of the hysterectomy portion of the case, i.e. closure of vaginal cuff and achievement of hemostasis from the hysterectomy. Secondary outcomes include intra-operative, peri-operative, and post-operative complications; post-operative patient outcomes as measured by the Short Form 36 (SF-36) questionnaire. Patient scores on this questionnaire before and after surgery can be used to calculate the quality adjusted life years (QALYs), which can then be used in the cost utility analysis. Patients' overall narcotic use and quality of life will also be assessed after surgery with diaries at different intervals. The diaries will consist of a daily narcotic/pain medication diary, a weekly assessment of return to normal activity, and assessments at 2, 4, and 6 weeks of surgical pain and ability to perform functional activities.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Prospective Randomized Trial Comparing Conventional vs. Robotic Assisted Laparoscopic Hysterectomy|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: 1
Conventional Laparoscopic Hysterectomy
Procedure: conventional laparoscopic hysterectomy
Total laparoscopic hysterectomy
Active Comparator: 2
Robotic Assisted Laparoscopic Hysterectomy
Procedure: robotic assisted laparoscopic hysterectomy
Robotic assisted laparoscopic hysterectomy with DaVinci robot
- Operative time from incision to either closure or, in the case of concomitant prolapse or incontinence procedures, the completion of the hysterectomy portion of the case, i.e. closure of vaginal cuff and achievement of hemostasis from the hysterectomy. [ Time Frame: Intra-operative time ]
- Peri-operative complications; comparison of costs; qualify of life issues; post-operative pain and narcotic use; return to normal activity [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485355
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Marie FR Paraiso, MD||The Cleveland Clinic|