Uterine Fibroids, Menorrhagia, EndometriosisNCT00485355
Study Comparing Conventional vs. Robotic-assisted Laparoscopic Hysterectomy
A study testing conventional laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy in people with Uterine Fibroids, Menorrhagia, Endometriosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare two ways of performing laparoscopic hysterectomy - robotic-assisted vs. conventional laparoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids, Menorrhagia, Endometriosis
- What is being tested?
- conventional laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women who are 18 years of age or greater who are to undergo laparoscopic hysterectomy for benign indications. Other concomitant laparoscopic or anti-incontinence procedures (e.g., excision of endometriosis or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.
Who cannot join
- suspected malignancy, medical illness precluding laparoscopy, inability to give informed consent, morbid obesity (BMI>40), or need for concomitant bowel resection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial Comparing Conventional vs. Robotic Assisted Laparoscopic Hysterectomy
The purpose of this study is to compare two ways of performing laparoscopic hysterectomy - robotic-assisted vs. conventional laparoscopy.
Read the 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 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.
- Being tested
- conventional laparoscopic hysterectomy, robotic assisted laparoscopic hysterectomy
- Keywords
- hysterectomy, Laparoscopy, robotics
- Medical subject headings
- Leiomyoma, Menorrhagia, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional laparoscopic hysterectomyProcedure or surgery
Total laparoscopic hysterectomy
robotic assisted laparoscopic hysterectomyProcedure or surgery
Robotic assisted laparoscopic hysterectomy with DaVinci robot
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Conventional Laparoscopic Hysterectomy Receives: Procedure: conventional laparoscopic hysterectomy |
| 2 | Active comparator | Robotic Assisted Laparoscopic Hysterectomy Receives: Procedure: robotic assisted laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-operative time
Secondary outcomes (1)
Peri-operative complications; comparison of costs; qualify of life issues; post-operative pain and narcotic use; return to normal activity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids, Menorrhagia, EndometriosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie FR Paraiso, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485355
- Sponsor's protocol ID
- 07-150
- Status last verified
- Aug 2013
- First submitted
- 11 Jun 2007
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Paraiso MF, Ridgeway B, Park AJ, Jelovsek JE, Barber MD, Falcone T, Einarsson JI. A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy. Am J Obstet Gynecol. 2013 May;208(5):368.e1-7. doi: 10.1016/j.ajog.2013.02.008. Epub 2013 Feb 8.
PubMed 23395927
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Conventional vs. Robotic Assisted Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT00485355
- Acronym / sponsor ID
- 07-150
- Keywords
- hysterectomy, Laparoscopy, robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: conventional laparoscopic hysterectomyConventional Laparoscopic Hysterectomy |
| 2 | Active comparator | Procedure: robotic assisted laparoscopic hysterectomyRobotic Assisted Laparoscopic Hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women who are 18 years of age or greater who are to undergo laparoscopic hysterectomy for benign indications. Other concomitant laparoscopic or anti-incontinence procedures (e.g., excision of endometriosis or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.
Key exclusion criteria (1 listed)
- suspected malignancy, medical illness precluding laparoscopy, inability to give informed consent, morbid obesity (BMI>40), or need for concomitant bowel resection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional laparoscopic hysterectomyTotal laparoscopic hysterectomy | Procedure or surgery | 1 |
| robotic assisted laparoscopic hysterectomyRobotic assisted laparoscopic hysterectomy with DaVinci robot | Procedure or surgery | 2 |
Primary outcome
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
1 secondary outcome
Peri-operative complications; comparison of costs; qualify of life issues; post-operative pain and narcotic use; return to normal activity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Results publication: PubMed 23395927Paraiso MF, Ridgeway B, Park AJ, Jelovsek JE, Barber MD, Falcone T, Einarsson JI. A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy. Am J Obstet Gynecol. 2013 May;208(5):368.e1-7. doi: 10.1016/j.ajog.2013.02.008. Epub 2013 Feb 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie FR Paraiso, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy in people with Uterine Fibroids, Menorrhagia, Endometriosis, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00485355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.