Clinical trial NCT02345954: Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study
Official title: Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterus Prolapse
Keywords: Uterus Prolapse
Laparoscopic Sacropexy
Laparoscopic Hysteropexy
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Operation time
timeFrame: expected average of 150 minutes
Secondary outcomes:
measure: Intra- and postoperative complication rate
timeFrame: 1 year
measure: Duration of anaesthesia
timeFrame: expected average of 200 minutes
measure: IUGA Pelvic Organ Prolapse Quantification (POP-Q)
timeFrame: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
measure: Bladder and bowel function, Prolapse symptoms, Sexuality
timeFrame: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
measure: Quality of Life
timeFrame: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
measure: Patient satisfaction after surgery
timeFrame: At follow up 6 weeks, 6 months and 12 months after intervention
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Aargau (AG)
Study officials:
affiliation: Kantonsspital Aarau
name: Dimitri Sarlos, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.