Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485355
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2007-06-11
Brief Title:
Study Comparing Conventional vs Robotic-assisted Laparoscopic Hysterectomy
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Prospective Randomized Trial Comparing Conventional vs Robotic Assisted Laparoscopic Hysterectomy
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare two ways of performing laparoscopic hysterectomy - robotic-assisted vs conventional laparoscopy
Detailed Description:
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 enrollOverall 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 eg 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 ie 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 narcoticpain 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
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 enrollOverall 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 eg 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 ie 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 narcoticpain 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None