Status:
RECRUITING
Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy
Lead Sponsor:
Zuyderland Medisch Centrum
Collaborating Sponsors:
Catharina Ziekenhuis Eindhoven
Conditions:
Hysterectomy
Natural Orifice Transluminal Endoscopic Surgery
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the hu...
Detailed Description
The hysterectomy is one of the most performed gynaecological surgeries worldwide. In the Netherlands about 14.500 hysterectomies are performed yearly. The most common benign indications to perform a ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04886791
Start Date
July 5 2021
End Date
December 31 2025
Last Update
August 14 2025
Active Locations (2)
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1
Catharina Medical Centre
Eindhoven, North Brabant, Netherlands
2
Zuyderland Medical Centre
Heerlen, North Brabant, Netherlands, 5644AD