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

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.

Conditions

• Leiomyoma, Uterine
• Benign Gynecological Disease
• Abnormal Uterine Bleeding (AUB)
• Uterine Prolapse
• Adenomyosis of Uterus

Interventions

DRUG

Deep 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

DRUG

Standard (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

OTHER

Preoperative 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

Sponsors & Collaborators

• Kutahya City Hospital

  collaborator OTHER

• Kocaeli City Hospital

  collaborator OTHER_GOV

• Dr. Lutfi Kirdar Kartal Training and Research Hospital

  collaborator OTHER_GOV

• Fatih Sultan Mehmet Training and Research Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2027-07-25

Completion

2027-09-01

Countries

• Turkey (Türkiye)

Study Locations