Deep muscle relaxation and a low-residue diet to improve the surgical view during vNOTES hysterectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized 2x2 factorial study, adult women scheduled for benign-indication hysterectomy via vNOTES are assigned to one of four groups: standard relaxation with or without a preoperative low-residue diet, and deep neuromuscular blockade with or without the diet. The primary outcome uses objective video-based scoring to determine the lowest intra-abdominal pressure at which the surgical field is adequate, with secondary assessment for optimal visibility. Deep relaxation targets a post-tetanic count of 1–2 with full reversal before extubation, while standard relaxation uses a train-of-four count of 1–2. The study excludes those with cancer or conditions that could complicate the vNOTES approach, and all participants receive sugammadex for reversal. Field visualization is assessed at multiple pressure steps using blinded evaluators and a predefined scoring index adapted for vNOTES.

Why it matters

Who can join: the full rules

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.

Where it's running

• Acibadem Kartal Hospital
  Istanbul, Kartal, Turkey (Türkiye) Recruiting
• Kartal Dr. Lütfi Kırdar Şehir Hastanesi
  Istanbul, Kartal, Turkey (Türkiye) Active not recruiting
• Kütahya Şehir Hastanesi
  Kütahya, Kütahya, Turkey (Türkiye) Active not recruiting

Study contacts

• Study coordinator: MURAT Y Murat Yassa, MD (Assoc. Prof.) - Principal Investigator, ASSOCIATE PROFESSOR IN OBS GYN
• Email: murat.yassa@acibadem.com
• Phone: +905335106312

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.