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โ† Trials
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Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy

RecruitingNAAges 18 Years - anyFemaleZuyderland Medisch Centrum
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In plain words

What the trial is, and whether it could suit you

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 human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy. Objective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness. Study design: The study concerns a single-blinded

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Vaginal NOTES hysterectomy
  • Vaginal hysterectomy
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Where

2 sites
Catharina Medical Centre
Eindhoven, Netherlands
Zuyderland Medical Centre
Heerlen, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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