Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study

NCT ID: NCT02345954

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Uterus Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supracervical Hysterectomy and Sacropexy

Laparoscopic Supracervical Hysterectomy and Sacropexy

Group Type EXPERIMENTAL

Laparoscopic Supracervical Hysterectomy and Sacropexy

Intervention Type PROCEDURE

Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy

Hysteropexy

Laparoscopic Hysteropexy

Group Type EXPERIMENTAL

Laparoscopic Hysteropexy

Intervention Type PROCEDURE

Laparoscopic hysteropexy

Interventions

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Laparoscopic Supracervical Hysterectomy and Sacropexy

Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy

Intervention Type PROCEDURE

Laparoscopic Hysteropexy

Laparoscopic hysteropexy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years
* Symptomatic uterus prolapse (uterus \< 300g)
* Patient able to sign the informed consent and to fulfil the follow up visits

Exclusion Criteria

* 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)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Aarau

OTHER

Sponsor Role lead

Responsible Party

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Dimitri Sarlos

Chair Department of Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimitri Sarlos, MD

Role: STUDY_CHAIR

Kantonsspital Aarau

Locations

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Kantonsspital Aarau

Aarau, Aargau (AG), Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dimitri Sarlos, MD

Role: CONTACT

+41 838 5065

Jean-Jacques Ries, MD

Role: CONTACT

+41 838 5995

Facility Contacts

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Dimitri Sarlos, MD

Role: primary

+41 62 838 5065

Jean-Jacques Ries, MD

Role: backup

+41 62 838 5995

References

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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.

Reference Type BACKGROUND
PMID: 22914470 (View on PubMed)

Wu 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.

Reference Type BACKGROUND
PMID: 19935030 (View on PubMed)

Khunda 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.

Reference Type BACKGROUND
PMID: 23298608 (View on PubMed)

Krause 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.

Reference Type BACKGROUND
PMID: 16319998 (View on PubMed)

Price 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.

Reference Type BACKGROUND
PMID: 20002370 (View on PubMed)

Other Identifiers

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lapSKPvslapHP

Identifier Type: -

Identifier Source: org_study_id

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