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*Vaginal hysterectomy versus vaginal Assisted NOTES Hysterectomy (VANH)*: a randomised controlled trial

Recruiting
Conditions
removal of uterus
Vaginal hysterectomy
10029903
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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
<p>The primary objective is the difference in percentage of SDD in both groups.</p><br>
Secondary Outcome Measures
NameTimeMethod
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