Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study

NCT02345954 | Unknown

• 1 other identifier: lapSKPvslapHP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterus Prolapse

Keywords

Uterus Prolapse; Laparoscopic Sacropexy; Laparoscopic Hysteropexy

Outcome Measures

Primary Outcomes (1)

• Operation time

  Comparison of operation time in the 2 arms of the study

  expected average of 150 minutes

Secondary Outcomes (6)

• Intra- and postoperative complication rate

  1 year

• Duration of anaesthesia

  expected average of 200 minutes

• IUGA Pelvic Organ Prolapse Quantification (POP-Q)

  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

  8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention

• Quality of Life

  8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention

Study Arms (2)

Supracervical Hysterectomy and Sacropexy

EXPERIMENTAL

Laparoscopic Supracervical Hysterectomy and Sacropexy

Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy

Hysteropexy

EXPERIMENTAL

Laparoscopic Hysteropexy

Procedure: Laparoscopic Hysteropexy

Interventions

Laparoscopic Supracervical Hysterectomy and Sacropexy PROCEDURE

Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy

Supracervical Hysterectomy and Sacropexy

Laparoscopic Hysteropexy PROCEDURE

Laparoscopic hysteropexy

Hysteropexy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Aarau: lead

Study Sites (1)

Kantonsspital Aarau

Aarau, Aargau (AG), 5001, Switzerland

RECRUITING

Related Publications (5)

• 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.

  PMID: 22914470 BACKGROUND

• 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.

  PMID: 19935030 BACKGROUND

• 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.

  PMID: 23298608 BACKGROUND

• 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.

  PMID: 16319998 BACKGROUND

• 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.

  PMID: 20002370 BACKGROUND

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dimitri Sarlos, MD

  Kantonsspital Aarau

  STUDY CHAIR

Central Study Contacts

Dimitri Sarlos, MD

CONTACT

+41 838 5065; dimitri.sarlos@ksa.ch

Jean-Jacques Ries, MD

CONTACT

+41 838 5995; Jean-Jacques.Ries@ksa.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Department of Gynecology

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: January 26, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

CH (1)