Vaginal hysterectomy versus vaginal Assisted NOTES Hysterectomy (VANH): a randomised controlled trial
- Conditions
- Benign indication for hysterectomy
- Registration Number
- NL-OMON29386
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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
-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 The primary objective is the difference in percentage of SDD in both groups.
- Secondary Outcome Measures
Name Time Method