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

Study acronym: vNOTES_NMBDIET
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Fatih Sultan Mehmet Training and Research Hospital

Record History

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  1. Notable Primary endpoint(s) modified
    • Enrollment reopened
    • Site details revised at 3 of 3 sites
    v3
  2. Notable Primary endpoint revised
    • Study sites: 1 to 3
    • Collaborators: 2 to 3
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 pressure is lowered step by step, and 2-3 blinded assessors score the field from de-identified video. The primary outcome is the lowest pressure at which the field remains adequate; a lower pressure indicates an intrinsically better field. The trial hypothesis is an interaction - that the combination achieves an adequate field at a meaningfully lower pressure than either measure alone. The final sample size is determined from an internal pilot. Secondary outcomes include the continuous field score, the need for an additional instrument to clear the field, postoperative nausea and vomiting, and routine operative outcomes.
Trial Details
NCT Number NCT07730970
Lead Sponsor Fatih Sultan Mehmet Training and Research Hospital
Collaborators: Kutahya City Hospital, Kocaeli City Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital
Conditions
(from sponsor)
Leiomyoma, Uterine, Benign Gynecological Disease, Abnormal Uterine Bleeding (AUB), Uterine Prolapse, Adenomyosis of Uterus
Related terms Adenomyosis, Leiomyoma, Metrorrhagia, Pneumoperitoneum, Uterine Prolapse
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov