*Vaginal hysterectomy versus vaginal Assisted NOTES Hysterectomy (VANH)*: a randomised controlled trial
- Conditions
- removal of uterusVaginal hysterectomy10029903
- Registration Number
- NL-OMON54088
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 124
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker or in control of the Dutch language in speaking and
writing
- Indication for hysterectomy for benign indication
- Possible to perform a VH judged by experienced (resident) gynaecologist
during gynaecological examination
- Any contra-indication for VH (for example, large uterus myomatosus, not
enough descensus, etc) as judged by experienced gynaecologist
- Contra-indication for general anaesthesia
- History of more than 1 caesarean section
- History of endometriosis
- History of rectal surgery
- History of pelvic radiation
- Suspected rectovaginal endometriosis
- History of pelvic inflammatory disease, especially prior tubo-ovarian or
pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory
disease (for example ruptured appendicitis)
- Virginity
- Pregnancy
- Indication for anterior or posterior colporrhaphy during the same surgery
- Indication of mid urethral slings
- Uterus myomatosus will not be an exclusion criteria but the surgeon will
indicate if it is possible to remove the uterus vaginally.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is the difference in percentage of SDD in both groups.</p><br>
- Secondary Outcome Measures
Name Time Method