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Search / Trial NCT04886791

Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy

Launched by ZUYDERLAND MEDISCH CENTRUM · May 13, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Notes Surgery V Notes Vanh Vaginal Hysterectomy Hysterectomy

ClinConnect Summary

This clinical trial is comparing two types of surgeries for removing the uterus: vaginal NOTES (vNOTES) hysterectomy and traditional vaginal hysterectomy. The goal is to see which method allows women to go home the same day after surgery, has fewer complications, and leads to better recovery and quality of life. The vNOTES technique is newer and uses natural openings in the body (like the vagina) to perform the surgery, which may result in less pain and no visible scars.

To participate, women must be at least 18 years old, speak Dutch, and need a hysterectomy for non-cancerous reasons. They should be healthy enough for a vaginal surgery, as determined by a doctor. Participants will be randomly assigned to one of the two surgery groups and will receive the same care before and after the surgery. Throughout the study, women will complete questionnaires about their health and recovery. This trial is currently recruiting participants and aims to provide valuable insights into the benefits and risks of these two surgical options.

Gender

FEMALE

Eligibility criteria

  • 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
  • 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.

About Zuyderland Medisch Centrum

Zuyderland Medisch Centrum is a leading healthcare institution in the Netherlands, renowned for its commitment to advancing medical research and improving patient care. With a multidisciplinary approach, the center integrates innovative clinical trials into its healthcare services, fostering collaboration among specialists to explore new therapies and treatment modalities. Zuyderland Medisch Centrum prioritizes patient safety and ethical standards in all research endeavors, aiming to contribute valuable insights to the medical community and enhance health outcomes for diverse populations. Through its state-of-the-art facilities and a dedicated team of researchers and clinicians, the center strives to remain at the forefront of medical advancements.

Locations

Eindhoven, Noord Brabant, Netherlands

Heerlen, Noord Brabant, Netherlands

Patients applied

0 patients applied

Trial Officials

Martine Wassen

Principal Investigator

Zuyderland Medical Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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