Uterus ProlapseHysPexNCT02345954
Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study
A study testing Laparoscopic Supracervical Hysterectomy and Sacropexy and Laparoscopic Hysteropexy in people with Uterus Prolapse, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the uterus). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterus Prolapse
- What is being tested?
- Laparoscopic Supracervical Hysterectomy and Sacropexy and Laparoscopic Hysteropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Oct 2023
- 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
- Patients older than 18 years
- Symptomatic uterus prolapse (uterus < 300g)
- Patient able to sign the informed consent and to fulfil the follow up visits
Who cannot join
- Indication: Pathologies of the uterus (postmen. bleeding, high endometrium at ultrasound (>5 mm), abnormal PAP smear in the last 5 years, bleeding anomalies in premenopausal patients
- General medical contraindications to a surgical operation
- tumor/ malignant disease
- bacterial infection at time of surgery
- drug or medication abuse at time or just before surfer
- Disease which would make a correct assessment of the patient impossible (e.g. psychiatric condition)
Show all 10Show fewer
- Known hypersensitivity to the implanted materials
- Immaturity, inability to answer/understand questions
- Planned pregnancy
- Participation to other studies (drugs or medical techniques) which could influence the results of this study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Aargau (AG), 5001
Dimitri Sarlos, MD, +41 62 838 5065, dimitri.sarlos@ksa.ch
Jean-Jacques Ries, MD, +41 62 838 5995, Jean-Jacques.Ries@ksa.ch
About this study
Official title: Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial
The purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the uterus).
The investigators expect that both laparoscopic procedures are equal in regards to operation time, complication rate, anatomic and functional outcome as well as subjective outcome.
- Conditions
- Uterus Prolapse
- Being tested
- Laparoscopic Supracervical Hysterectomy and Sacropexy, Laparoscopic Hysteropexy
- Keywords
- Uterus Prolapse, Laparoscopic Sacropexy, Laparoscopic Hysteropexy
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Supracervical Hysterectomy and SacropexyProcedure or surgery
Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy
Laparoscopic HysteropexyProcedure or surgery
Laparoscopic hysteropexy
| Study group | Role | What they receive |
|---|---|---|
| Supracervical Hysterectomy and Sacropexy | Experimental | Laparoscopic Supracervical Hysterectomy and Sacropexy Receives: Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy |
| Hysteropexy | Experimental | Laparoscopic Hysteropexy Receives: Procedure: Laparoscopic Hysteropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Comparison of operation time in the 2 arms of the study
Measured: expected average of 150 minutes
Secondary outcomes (6)
Intra- and postoperative complication rate
Measured: 1 year
Duration of anaesthesia
Measured: expected average of 200 minutes
IUGA Pelvic Organ Prolapse Quantification (POP-Q)
Measured: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Bladder and bowel function, Prolapse symptoms, Sexuality
Assessed via Pelvic Function Questionnaire
Measured: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Quality of Life
EQ-5D-5L questionnaire
Measured: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Patient satisfaction after surgery
Measured: At follow up 6 weeks, 6 months and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uterus ProlapseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Sarlos, Kantonsspital Aarau
- Investigators
- Dimitri Sarlos, MD, Study chair, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345954
- Sponsor's protocol ID
- lapSKPvslapHP
- Acronym
- HysPex
- Status last verified
- Sep 2020
- First submitted
- 21 Nov 2014
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a.
PubMed 22914470Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
PubMed 19935030Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5.
PubMed 23298608Krause HG, Goh JT, Sloane K, Higgs P, Carey MP. Laparoscopic sacral suture hysteropexy for uterine prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):378-81. doi: 10.1007/s00192-005-0019-0. Epub 2005 Nov 30.
PubMed 16319998Price N, Slack A, Jackson SR. Laparoscopic hysteropexy: the initial results of a uterine suspension procedure for uterovaginal prolapse. BJOG. 2010 Jan;117(1):62-8. doi: 10.1111/j.1471-0528.2009.02396.x.
PubMed 20002370
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02345954
- Acronym / sponsor ID
- HysPex / lapSKPvslapHP
- Conditions
- Uterus Prolapse
- Keywords
- Uterus Prolapse, Laparoscopic Sacropexy, Laparoscopic Hysteropexy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 26 Jan 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.
The purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the uterus).
The investigators expect that both laparoscopic procedures are equal in regards to operation time, complication rate, anatomic and functional outcome as well as subjective outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supracervical Hysterectomy and Sacropexy | Experimental | Procedure: Laparoscopic Supracervical Hysterectomy and SacropexyLaparoscopic Supracervical Hysterectomy and Sacropexy |
| Hysteropexy | Experimental | Procedure: Laparoscopic HysteropexyLaparoscopic Hysteropexy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Symptomatic uterus prolapse (uterus < 300g)
- Patient able to sign the informed consent and to fulfil the follow up visits
Key exclusion criteria (10 listed)
- Indication: Pathologies of the uterus (postmen. bleeding, high endometrium at ultrasound (>5 mm), abnormal PAP smear in the last 5 years, bleeding anomalies in premenopausal patients
- General medical contraindications to a surgical operation
- Disease which would make a correct assessment of the patient impossible (e.g. psychiatric condition)
- Known hypersensitivity to the implanted materials
- Immaturity, inability to answer/understand questions
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 |
|---|---|---|
| Laparoscopic Supracervical Hysterectomy and SacropexyLaparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy | Procedure or surgery | Supracervical Hysterectomy and Sacropexy |
| Laparoscopic HysteropexyLaparoscopic hysteropexy | Procedure or surgery | Hysteropexy |
Primary outcome
Operation time
Time frame: expected average of 150 minutes
Comparison of operation time in the 2 arms of the study
6 secondary outcomes
Intra- and postoperative complication rate
Time frame: 1 year
Duration of anaesthesia
Time frame: expected average of 200 minutes
IUGA Pelvic Organ Prolapse Quantification (POP-Q)
Time frame: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Bladder and bowel function, Prolapse symptoms, Sexuality
Time frame: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Quality of Life
Time frame: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Patient satisfaction after surgery
Time frame: At follow up 6 weeks, 6 months and 12 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Background: PubMed 22914470Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a.
- Background: PubMed 19935030Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
- Background: PubMed 23298608Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5.
- Background: PubMed 16319998Krause HG, Goh JT, Sloane K, Higgs P, Carey MP. Laparoscopic sacral suture hysteropexy for uterine prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):378-81. doi: 10.1007/s00192-005-0019-0. Epub 2005 Nov 30.
- Background: PubMed 20002370Price N, Slack A, Jackson SR. Laparoscopic hysteropexy: the initial results of a uterine suspension procedure for uterovaginal prolapse. BJOG. 2010 Jan;117(1):62-8. doi: 10.1111/j.1471-0528.2009.02396.x.
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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.
Dimitri Sarlos, MD study chair
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Supracervical Hysterectomy and Sacropexy and Laparoscopic Hysteropexy in people with Uterus Prolapse, run by Kantonsspital Aarau at 1 site in Switzerland.
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 3 inclusion and 10 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 2 Sep 2020. 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 Switzerland. 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 Dimitri Sarlos, MD (+41 838 5065, dimitri.sarlos@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: expected average of 150 minutes). 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 NCT02345954, which also lists 5 linked publications.
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 2 Sep 2020.