Vaginal BleedingLSH-LAPCONENCT00921778
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
A study testing Lapcone and laparoscopic supracervical hysterectomy in people with Vaginal Bleeding, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
The occurrence of persistent vaginal bleeding following laparoscopic supracervical hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists have claimed that removal of any remaining endometrium in a reverse cone pattern at the time of the hysterectomy reduces the occurrence of… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Bleeding
- What is being tested?
- Lapcone and laparoscopic supracervical hysterectomy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2008to Dec 2011
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All premenopausal women who are referred to the departement due to a benign condition requiring hysterectomy and who have given informed consent are eligible for study recruitment
Who cannot join
- Women who are unable to communicate in written Norwegian or oral English language.
- Woman with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative smear or wtih atypical hyperplasia og malignancy in preoperative endometrial biopsy
- Women who after a thorough clinical evaluation are found to be more suited for vaginal, abdominal or total hysterectomy
- Women with a coexisting condition requiring no remaining ovaries after the procedure
- Postmenopausal women
- Women using hormone therapy (HT)
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Ullevaal University Hospital
Oslo
Espen Berner, MD, +47 48007701, espen.berner@uus.no
Marit Lieng, MD, +47 98606578, marit.lieng@uus.no
About this study
The occurrence of persistent vaginal bleeding following laparoscopic supracervical hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists have claimed that removal of any remaining endometrium in a reverse cone pattern at the time of the hysterectomy reduces the occurrence of persistent vaginal bleeding to a minimum. The effect of this particular technique has not been reported.
Ullevaal University Hospital have developed an unipolar electrode for this study (Lapcone electrode, mod. UUS, L: 25cm, 6x10, Art. No. REM-270, Ross Electro Medical Ltd, Unit K1\&K2, Quarry Fields Estate, Mere, Wiltshire BA12 6LA, London, UK). The electrode is CE approved.
Read more
Outcome: 1.Occurrence of vaginal bleeding 12 months after the procedure. 2. Patient satisfaction 12 months after the procedure (10-point analogue scale).
Design: Prospective randomised trial. Methods; The study participants are randomised to laparoscopic supracervical hysterectomy performed by perioperative electrocoagulation from the upper cervical canal (n=70) or performed by excision of the endocervix in a reverse cone pattern followed by electrocoagulation of the upper cervical canal (n =70).
- Conditions
- Vaginal Bleeding
- Being tested
- Lapcone, laparoscopic supracervical hysterectomy
- Keywords
- Laparoscopic supracervical hysterectomy, Vaginal bleeding, Patient satisfaction, vaginal bleeding after laparoscopic hysterectomy
- Medical subject headings
- Uterine Hemorrhage, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapconeDevice
Use of Lapcone during LSH
laparoscopic supracervical hysterectomyProcedure or surgery
laparoscopic supracervical hysterectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of vaginal bleeding 12 months after the procedure.
Measured: 12 months after operation
Secondary outcomes (1)
Patient satisfaction 12 months after the procedure (10-point analogue scale).
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal BleedingStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921778
- Sponsor's protocol ID
- LSH-LAPCONE UUS
- Acronym
- LSH-LAPCONE
- Status last verified
- Aug 2008
- First submitted
- 15 Jun 2009
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
- ClinicalTrials.gov ID
- NCT00921778
- Acronym / sponsor ID
- LSH-LAPCONE / LSH-LAPCONE UUS
- Conditions
- Vaginal Bleeding
- Keywords
- Laparoscopic supracervical hysterectomy, Vaginal bleeding, Patient satisfaction, vaginal bleeding after laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Jun 2009 (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 occurrence of persistent vaginal bleeding following laparoscopic supracervical hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists have claimed that removal of any remaining endometrium in a reverse cone pattern at the time of the hysterectomy reduces the occurrence of persistent vaginal bleeding to a minimum. The effect of this particular technique has not been reported.
Ullevaal University Hospital have developed an unipolar electrode for this study (Lapcone electrode, mod. UUS, L: 25cm, 6x10, Art. No. REM-270, Ross Electro Medical Ltd, Unit K1\&K2, Quarry Fields Estate, Mere, Wiltshire BA12 6LA, London, UK). The electrode is CE approved.
Outcome: 1.Occurrence of vaginal bleeding 12 months after the procedure. 2. Patient satisfaction 12 months after the procedure (10-point analogue scale).
Design: Prospective randomised trial. Methods; The study participants are randomised to laparoscopic supracervical hysterectomy performed by perioperative electrocoagulation from the upper cervical canal (n=70) or performed by excision of the endocervix in a reverse cone pattern followed by electrocoagulation of the upper cervical canal (n =70).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All premenopausal women who are referred to the departement due to a benign condition requiring hysterectomy and who have given informed consent are eligible for study recruitment
Key exclusion criteria (6 listed)
- Women who are unable to communicate in written Norwegian or oral English language.
- Woman with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative smear or wtih atypical hyperplasia og malignancy in preoperative endometrial biopsy
- Women who after a thorough clinical evaluation are found to be more suited for vaginal, abdominal or total hysterectomy
- Women with a coexisting condition requiring no remaining ovaries after the procedure
- Postmenopausal women
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 |
|---|---|---|
| LapconeUse of Lapcone during LSH | Device | – |
| laparoscopic supracervical hysterectomylaparoscopic supracervical hysterectomy | Procedure or surgery | – |
Primary outcome
Occurrence of vaginal bleeding 12 months after the procedure.
Time frame: 12 months after operation
1 secondary outcome
Patient satisfaction 12 months after the procedure (10-point analogue scale).
Time frame: 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
- homepage Ullevaal University HospitalLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lapcone and laparoscopic supracervical hysterectomy in people with Vaginal Bleeding, run by Ullevaal University Hospital at 1 site in Norway.
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 6 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 16 Jun 2009. 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 Norway. 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 Espen Berner, MD (+47 48007701, espen.berner@uus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of vaginal bleeding 12 months after the procedure. (time frame: 12 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2009.