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Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy

RecruitingNAAges 18 Years - anyFemaleFatih Sultan Mehmet Training and Research Hospital
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In plain words

What the trial is, and whether it could suit you

vNOTES (vaginal natural orifice transluminal endoscopic surgery) hysterectomy is performed entirely through the vagina, with no abdominal incision. A clear surgical view is essential, and the main obstacle to the view is bowel falling into the pelvis. This randomized trial tests whether two simple measures improve the surgical field, individually or in combination: a preoperative low-residue diet for three days, and deeper intra-operative muscle relaxation (deep neuromuscular blockade). No group receives mechanical bowel preparation. Using a 2×2 factorial design, participants are allocated equally (1:1:1:1) to one of four groups: (1) no diet with standard relaxation; (2) diet with standard relaxation; (3) no diet with deep relaxation; (4) diet with deep relaxation (the "bundle"). The surgical field is measured objectively: during a standardized window the carbon-dioxide insufflation pre

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult women (aged 18 years or older) scheduled for hysterectomy for a benign (non-cancer) indication. * Judged suitable for the vNOTES approach by the operating surgeon. * Able to understand the study and provide written informed consent. Exclusion Criteria: * Suspected or known gynaecological malignancy. * Conditions expected to make the approach or the field assessment non-standard (e.g., anticipated dense pelvic adhesions or severe endometriosis, a contraindication to vNOTES, or an obliterated cul-de-sac). * Any medical reason why deep neuromuscular blockade or sugammadex would be unsafe (defined with the anaesthesia team). * Any medical reason why a low-residue diet would be unsuitable. * Inability to give informed consent.
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What it tests

  • Deep Neuromuscular Blockade (NMB)
  • Standard (moderate) neuromuscular blockade
  • Preoperative low-residue diet
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Where

3 sites
Kartal Dr. Lütfi Kırdar Şehir Hastanesi
Istanbul, Turkey (Türkiye)
Acibadem Kartal Hospital
Istanbul, Turkey (Türkiye)
Kütahya Şehir Hastanesi
Kütahya, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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