Comparing two types of hysterectomy procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare vaginal NOTES hysterectomy with traditional vaginal hysterectomy in terms of same-day discharge, complications, treatment outcomes, post-operative recovery, quality of life, and cost-effectiveness. The study utilizes a single-blinded, multicentre, randomized controlled design to gather data from eligible women undergoing hysterectomy for benign conditions. The trial is motivated by the potential advantages of the vaginal NOTES approach, which may offer less pain and shorter hospital stays compared to other surgical methods.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zuyderland Medical Centre
  Heerlen, North Brabant, Netherlands Recruiting
• Catharina Medical Centre
  Eindhoven, North Brabant, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Martine Wassen — Zuyderland Medical Centre
• Study coordinator: Ilse Bekkers
• Email: il.bekkers@zuyderland.nl
• Phone: 0031640970334

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predictors of Success and Failure of v-NOTES Hysterectomy for Large Uteri

  This study looks at which factors predict whether a v-NOTES hysterectomy for large uteri will be completed without needing to switch to another surgical approach.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07895953

• Hybrid robotic surgery for gynecologic procedures using ROB platform

  This study tests whether the ROB robotic platform and its endoscopic instruments can be safely used to perform laparoscopic hysterectomy with or without removal of tubes and/or ovaries in adult women.

  Recruiting Rob Surgical Systems S.L. · Inca, Balearic Islands and 1 other locations · NCT07832539

• Biofeedback-Assisted Pelvic Floor Training After Hysterectomy

  This study tests whether biofeedback-guided pelvic floor exercises after hysterectomy can improve pelvic floor strength, reduce urinary leakage, lessen genital prolapse, and boost quality of life.

  Recruiting Kafrelsheikh University · Kafr ash Shaykh, Kafrelsheikh · NCT07784465

• Effectiveness of M-TAPA nerve block for pain relief after laparoscopic hysterectomy

  This study tests whether the M-TAPA nerve block before surgery can reduce opioid use and pain after laparoscopic hysterectomy compared with standard pain care.

  Recruiting Istinye University · Istanbul · NCT07483190

• Reading a personal narrative book to help emotional regulation before hysterectomy in young women

  This trial tests whether reading a personal narrative book in addition to usual care can help young women preparing for hysterectomy feel calmer and less anxious or depressed.

  Recruiting at 4 sites Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI) · Bordeaux and 3 other locations · NCT07430488

• vNOTE Hysterectomy with Uterosacral Suspension to Support Pelvic Organs

  This study tests a vaginal natural orifice surgery technique for hysterectomy that includes upfront uterosacral suspension to help prevent pelvic organ prolapse.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07413861

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.