Fibroma, BleedingNCT02610985
2-D and 3-D Laparoscopic Hysterectomy
A study testing 3-D laparoscopy and 2-D laparoscopy in people with Fibroma, Bleeding, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Background: No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroma, Bleeding
- What is being tested?
- 3-D laparoscopy and 2-D laparoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients referred for laparoscopic hysterectomy with or without bilateral salpingectomy or bilateral salpingooophorectomy for benign indications.
Who cannot join
- Women not suitable for laparoscopic hysterectomy including:
- Ultrasound appraisal of uterus weight > 1000 gram
- Need for prolapse surgery and therefore indication for vaginal hysterectomy.
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Sjaellands Univercety Hospital
Roskilde, Region Sjælland, 4000
Elise Hoffmann, MD, 20252017, elisehoffmann78@gmail.com
About this study
Official title: 3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial
Background:
No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.
Read more
Objective:
To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time.
Design:
Investigator-initiated, blinded, randomised controlled trial.
Intervention description:
Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D.
Trial size Roskilde/Herlev Hospital, Denmark:
200 patients in each arm of the study.
- Conditions
- Fibroma, Bleeding
- Being tested
- 3-D laparoscopy, 2-D laparoscopy
- Keywords
- Imaging, Three-Dimensional, Hysterectomy, laparoscopic hysterectomy
- Medical subject headings
- Fibroma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D laparoscopyDevice
3-D laparoscopy
2-D laparoscopyDevice
2-D laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| 2-Dimensional laparoscopic hysterectomy | Active comparator | traditional 2-D laparoscopy Receives: Device: 2-D laparoscopy |
| 3-Dimensional laparoscopic hysterectomy | Experimental | experimental 3-D laparoscopy Receives: Device: 3-D laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on SF 36 psychical health survey 6 weeks after surgery
Measured: 6 weeks
Pain (VAS score) assessed immediately at return to the gynaecological unit (about 5 hours postoperatively) and (VAS score) in the morning days 1-3 postoperatively.
Measured: 3 days
Secondary outcomes (5)
Major complications during the operation, postoperative complications
Measured: 6 weeks
Minor complications during the operation, postoperative complications
Measured: 6 weeks
Score on SF 36 mental health survey 6 weeks after surgery
Measured: 6 weeks
Length of hospital stay
Measured: 6 weeks
Operative time
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startSep 2016
- Primary completionDec 2018 (estimated)
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 Fibroma, BleedingStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elise Hoffmann, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610985
- Sponsor's protocol ID
- 2D/3D hysterectomy
- Status last verified
- Apr 2018
- First submitted
- 16 Nov 2015
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoffmann E, Bennich G, Larsen CR, Lindschou J, Jakobsen JC, Lassen PD. 3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial. BMC Womens Health. 2017 Sep 7;17(1):76. doi: 10.1186/s12905-017-0434-7.
PubMed 28882141
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02610985
- Acronym / sponsor ID
- 2D/3D hysterectomy
- Conditions
- Fibroma, Bleeding
- Keywords
- Imaging, Three-Dimensional, Hysterectomy, laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 20 Nov 2015 (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.
Background:
No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.
Objective:
To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time.
Design:
Investigator-initiated, blinded, randomised controlled trial.
Intervention description:
Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D.
Trial size Roskilde/Herlev Hospital, Denmark:
200 patients in each arm of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-Dimensional laparoscopic hysterectomy | Active comparator | Device: 2-D laparoscopytraditional 2-D laparoscopy |
| 3-Dimensional laparoscopic hysterectomy | Experimental | Device: 3-D laparoscopyexperimental 3-D laparoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients referred for laparoscopic hysterectomy with or without bilateral salpingectomy or bilateral salpingooophorectomy for benign indications.
Key exclusion criteria (4 listed)
- Women not suitable for laparoscopic hysterectomy including:
- Inability to give informed consent
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 |
|---|---|---|
| 3-D laparoscopy3-D laparoscopy | Device | 3-Dimensional laparoscopic hysterectomy |
| 2-D laparoscopy2-D laparoscopy | Device | 2-Dimensional laparoscopic hysterectomy |
Primary outcome
Score on SF 36 psychical health survey 6 weeks after surgery
Time frame: 6 weeks
Pain (VAS score) assessed immediately at return to the gynaecological unit (about 5 hours postoperatively) and (VAS score) in the morning days 1-3 postoperatively.
Time frame: 3 days
5 secondary outcomes
Major complications during the operation, postoperative complications
Time frame: 6 weeks
Minor complications during the operation, postoperative complications
Time frame: 6 weeks
Score on SF 36 mental health survey 6 weeks after surgery
Time frame: 6 weeks
Length of hospital stay
Time frame: 6 weeks
Operative time
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Derived from this study: PubMed 28882141Hoffmann E, Bennich G, Larsen CR, Lindschou J, Jakobsen JC, Lassen PD. 3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial. BMC Womens Health. 2017 Sep 7;17(1):76. doi: 10.1186/s12905-017-0434-7.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-D laparoscopy and 2-D laparoscopy in people with Fibroma, Bleeding, run by Zealand University Hospital at 1 site in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Apr 2018. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise Hoffmann, MD (+45 20252017, elisehoffmann78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on SF 36 psychical health survey 6 weeks after surgery (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT02610985, 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 3 Apr 2018; AzTrials last refreshed its copy on 4 Nov 2026.