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Cross-sectional study to assess the prevalence of vaginal vault prolapse after laparoscopic hysterectomy as a long-term complication.


- candidate number25516
- NTR NumberNTR6333
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-nov-2016
- Secondary IDsNL60096.015.16 METC Máxima Medisch Centrum
- Public TitleCross-sectional study to assess the prevalence of vaginal vault prolapse after laparoscopic hysterectomy as a long-term complication.
- Scientific TitlePelvic Organ Prolapse after laparoscopic Uterus extirpation: Postoperative long-term complication?
- ACRONYMPOP-UP
- hypothesisThe primary objective of this study is to review the prevalence of pelvic organ prolapse after laparoscopic hysterectomy compared to vaginal hysterectomy. Because the uterosacral ligaments are the important structure for vault suspension after hysterectomy and are not harmed during laparoscopy, we hypothesize that laparoscopic hysterectomy results in less long-term prolapses compared to vaginal hysterectomy
- Healt Condition(s) or Problem(s) studiedHysterectomy, Prolapse, Pelvic floor function
- Inclusion criteria- Women with laparoscopic or vaginal hysterectomy between 1996-2004
- Hysterectomy for benign indication
- Women who are still alive and mobile
- Women who are aged under 80 years
- Women who understand the Dutch language
- Exclusion criteria- Subtotal or abdominal hysterectomy
- Hysterectomy for malignant disease
- Women who have passed away
- Women who are aged 80 years or older
- Women who do not understand the Dutch language
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2017
- planned closingdate1-okt-2017
- Target number of participants900
- Interventions- Questionnaire: PFDI-20 (pelvic floor distress inventory), validated in Dutch population. This questionnaire entails questions on pelvic floor problems and/or discomfort within the last three months. Details on micturition, defecation and other prolapse symptoms are addressed.
- Physical examination: POP-Q pelvic organ prolapse quantification. This is a validated, non-invasive, safe way to objectify pelvic organ prolapse during pelvic floor exam.
- Primary outcome- Incidence of anatomic vault prolapse ¡Ý stage II
- Incidence of symptomatic vault prolapse (¡Ý stage II + sensation of a bulge)
- Incidence of asymptomatic and treated vault prolapse (conservative and surgical)
Same for prolapse in anterior and posterior compartment
- Secondary outcome- Incidence of conservative treatment for POP: pelvic floor exercise, vaginal pessary
- Incidence of POP surgery: pelvic floor repair (anterior repair, posterior repair, vaginal vault lift by sacrospinous fixation or sacral colpopexy.
- POP symptoms using PFDI-20 questionnaire (Pelvic Floor Distress Inventory)
- POP-Q values
- TimepointsBoth the questionnaire and POP-Q exam will take place before end of the study.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESdrs. Joggem Veen
- CONTACT for SCIENTIFIC QUERIES Carolien Vermeulen
- Sponsor/Initiator Maxima Medisch Centrum, Afdeling gynaecologie
- Funding
(Source(s) of Monetary or Material Support)
Wetenschapsfonds maxima medical center
- Publications
- Brief summaryRationale: Hysterectomy in general is a proven risk factor for pelvic organ prolapse (POP), which can seriously discomfort women at any age and often results in surgical repair. Long-term studies for pelvic organ prolapse after the recently added laparoscopic approach have not yet been performed. Because the uterosacral ligaments have an important function for the level one support of the pelvic floor and are not harmed during laparoscopy, we believe that laparoscopic hysterectomy (LH) might result in less long-term POP problems compared to VH, when performed for the same, benign indication.
Objective: The primary objective of this study is to review the incidence of pelvic organ prolapse after laparoscopic hysterectomy compared to vaginal hysterectomy.
Patients and Methods: A cohort study will be performed of patients who underwent laparoscopic or vaginal hysterectomy in a single center in the period of 1996 to 2004. The following items will be examined: prolapse treatment (both conservative and surgical), current pelvic floor complaints and observed POP on POP-examination. We will use a questionnaire (PFDI-20) and patients will undergo a one-time pelvic floor exam using the POP-Q. The population will exist of women, aged thirty to eighty, who underwent laparoscopic or vaginal hysterectomy for benign indications between 1996 and 2004 in the Máxima Medical Center (MMC).
- Main changes (audit trail)
- RECORD9-nov-2016 - 28-mei-2017


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