RecruitingNot ApplicableNCT07730970

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

Effect of Deep Neuromuscular Blockade and a Preoperative Low-Residue Diet on Intra-operative Surgical Field Conditions During Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Hysterectomy: A 2×2 Factorial, Assessor-Blinded Randomized Controlled Trial


Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Enrollment

160 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Deep Neuromuscular Blockade (NMB), Preoperative low-residue diet, and others for people with abnormal uterine bleeding (aub), adenomyosis of uterus, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDeep Neuromuscular Blockade (NMB)

Rocuronium by continuous infusion to maintain profound relaxation (no train-of-four twitches; post-tetanic count 1-2) until the end of the field measurement and surgery; reversed with sugammadex and confirmation of full recovery (train-of-four ratio ≥ 0.9) before extubation. Cross-reference to arms: Arms 3, 4

DRUGStandard (moderate) neuromuscular blockade

Rocuronium by intermittent bolus to maintain a train-of-four count of 1-2 (usual care); reversed with sugammadex and confirmation of full recovery (train-of-four ratio ≥ 0.9) before extubation. Cross-reference to arms: Arms 1, 2

OTHERPreoperative low-residue diet

A low-residue diet (less than 10 g dietary fibre per day) for the three days before surgery, with standardised food lists and a patient information sheet. This is a dietary measure, not a laxative; no mechanical bowel preparation is used. Cross-reference to arms: Arms 2, 4


Locations(3)

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, KARTAL, Turkey (Türkiye)

Acibadem Kartal Hospital

Istanbul, KARTAL, Turkey (Türkiye)

Kütahya Şehir Hastanesi

Kütahya, Kütahya, Turkey (Türkiye)

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NCT07730970


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