MenorrhagiaNCT02118974
Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
A study testing Hysterectomy in people with Menorrhagia and Pelvic Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Menorrhagia, Pelvic Pain, Hysterectomy
- What is being tested?
- Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Apr 2015
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing Hysterectomy
- Able to consent to the procedure
Who cannot join
- Medical conditions not allowing for pneumoperitoneum
- Medical conditions not allowing proper ventilation during anesthesia
- Pelvic organ prolapse amendable to a vaginal approach
- Pregnant women
- Patients undergoing planned combined procedures including bowel resection (other than coincidental appendectomy) or major urologic procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. We designed a randomized-controlled trial to compare operative times, length of hospital stay, estimated blood loss, and post-operative complications associated with these two methods of minimally invasive hysterectomy.
Read the detailed description
The proposed study will be a non-blinded randomized control trial. Patients will be randomized into each group Conventional Laparoscopic Hysterectomy (Group #1) and Robot-Assisted Laparoscopic Hysterectomy (Group #2) using a random number generator. Data collection will occur during the following points of patient interaction: pre-operative appointment, the surgical procedure, the patient's hospitalization, first post-operative appointment, and final post-operative appointment.
The care for the patients enrolled in this study will not deviate from the standard care of patients who are currently undergoing laparoscopic and robot-assisted laparoscopic hysterectomy. The patients who present to the office for pre-operative history and physical examination for laparoscopic hysterectomy will be counseled about participation in this study. Basic data collection will commence at the pre-operative visiting, including: patient demographics, past medical history, past surgical history, physical exam findings, and imaging results. The pre-operative appointment will occur between one to thirty days prior to surgery. Intra-operative and immediate post-operative data will be collected by the surgical assistant (resident or fellow) and will include surgical procedure (conventional laparoscopic or robot-assisted), operative time, hematocrit, estimated blood loss, length of stay, and complications.
- Conditions
- Menorrhagia, Pelvic Pain, Hysterectomy
- Being tested
- Hysterectomy
- Keywords
- Hysterectomy, Robot-assisted, Laparoscopy
- Medical subject headings
- Menorrhagia, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysterectomyProcedure or surgery
Hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted | Experimental | Robot-assisted hysterectomy Receives: Procedure: Hysterectomy |
| Laparoscopic Hysterectomy | Experimental | Laparoscopic Hysterectomy Receives: Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
The primary end point is difference in operative time
Measured: Intra operative
Secondary outcomes (1)
Complications
Complications related to the procedure including delays in discharge and re-admissions will be monitored and evaluated individually throughout the study.
Measured: up to 6 weeks following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionApr 2015
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 MenorrhagiaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy A Deimling, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118974
- Sponsor's protocol ID
- STUDY00000164
- Status last verified
- Jan 2017
- First submitted
- 16 Apr 2014
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Deimling TA, Eldridge JL, Riley KA, Kunselman AR, Harkins GJ. Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy. Int J Gynaecol Obstet. 2017 Jan;136(1):64-69. doi: 10.1002/ijgo.12001. Epub 2016 Nov 3.
PubMed 28099699
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT02118974
- Acronym / sponsor ID
- STUDY00000164
- Conditions
- Menorrhagia, Pelvic Pain, Hysterectomy
- Keywords
- Hysterectomy, Robot-assisted, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Apr 2014 (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.
Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. We designed a randomized-controlled trial to compare operative times, length of hospital stay, estimated blood loss, and post-operative complications associated with these two methods of minimally invasive hysterectomy.
Detailed description
The proposed study will be a non-blinded randomized control trial. Patients will be randomized into each group Conventional Laparoscopic Hysterectomy (Group #1) and Robot-Assisted Laparoscopic Hysterectomy (Group #2) using a random number generator. Data collection will occur during the following points of patient interaction: pre-operative appointment, the surgical procedure, the patient's hospitalization, first post-operative appointment, and final post-operative appointment.
The care for the patients enrolled in this study will not deviate from the standard care of patients who are currently undergoing laparoscopic and robot-assisted laparoscopic hysterectomy. The patients who present to the office for pre-operative history and physical examination for laparoscopic hysterectomy will be counseled about participation in this study. Basic data collection will commence at the pre-operative visiting, including: patient demographics, past medical history, past surgical history, physical exam findings, and imaging results. The pre-operative appointment will occur between one to thirty days prior to surgery. Intra-operative and immediate post-operative data will be collected by the surgical assistant (resident or fellow) and will include surgical procedure (conventional laparoscopic or robot-assisted), operative time, hematocrit, estimated blood loss, length of stay, and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted | Experimental | Procedure: HysterectomyRobot-assisted hysterectomy |
| Laparoscopic Hysterectomy | Experimental | Procedure: HysterectomyLaparoscopic Hysterectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing Hysterectomy
- Able to consent to the procedure
Key exclusion criteria (5 listed)
- Medical conditions not allowing for pneumoperitoneum
- Medical conditions not allowing proper ventilation during anesthesia
- Pelvic organ prolapse amendable to a vaginal approach
- Pregnant women
- Patients undergoing planned combined procedures including bowel resection (other than coincidental appendectomy) or major urologic procedures.
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 |
|---|---|---|
| HysterectomyHysterectomy | Procedure or surgery | Laparoscopic Hysterectomy, Robot-assisted |
Primary outcome
Operative Time
Time frame: Intra operative
The primary end point is difference in operative time
1 secondary outcome
Complications
Time frame: up to 6 weeks following intervention
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 20 Jan 2017.
- Derived from this study: PubMed 28099699Deimling TA, Eldridge JL, Riley KA, Kunselman AR, Harkins GJ. Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy. Int J Gynaecol Obstet. 2017 Jan;136(1):64-69. doi: 10.1002/ijgo.12001. Epub 2016 Nov 3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysterectomy in people with Menorrhagia and Pelvic Pain, run by Milton S. Hershey Medical Center 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 2 inclusion and 5 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 20 Jan 2017. 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 (time frame: Intra operative). 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 NCT02118974, 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 20 Jan 2017.