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.
Inclusion Criteria:
Exclusion Criteria:
murat.yassa@acibadem.com
Primary outcome scored by 2-3 independent assessors from de-identified video (insufflation pressure and group label removed). The operating surgeon is blinded to allocation (relaxation monitor covered/turned away) and the data analyst analyses with groups coded. The anaesthesia team is necessarily unblinded to relaxation depth but does not score the outcome; participants are not told their relaxation group and the diet cannot be fully masked from the participant.
Usual care: standard (moderate) neuromuscular blockade (train-of-four 1-2, intermittent bolus) and no dietary restriction. No mechanical bowel preparation.
Three-day preoperative low-residue diet with standard (moderate) neuromuscular blockade. No mechanical bowel preparation.
Deep neuromuscular blockade (post-tetanic count 1-2, continuous infusion) with no dietary restriction. No mechanical bowel preparation.
Three-day low-residue diet AND deep neuromuscular blockade - the combination of interest. No mechanical bowel preparation.
Istanbul, KARTAL 34865, Turkey (Türkiye)
Istanbul, KARTAL, Turkey (Türkiye)
murat.yassa@acibadem.com+905335106312
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