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

NCT07730970 | Recruiting

• 1 other identifier: ATADEK 2026/12, 2026-12/513
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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); Adenomyosis of Uterus; Uterine Prolapse

Keywords

vNOTES; vaginal natural orifice transluminal endoscopic surgery; deep neuromuscular blockade; rocuronium; post-tetanic count; low-residue diet; bowel preparation; insufflation pressure; pneumoperitoneum; surgical field; visualization; objective visualisation index (OVI); factorial trial; assessor-blinded

Outcome Measures

Primary Outcomes (1)

• Lowest CO₂ insufflation pressure at which the surgical field is adequate (blinded Transvaginal Natural Orifice Endoluminal Surgery - Objectiveisual Index: vNOTES-OVI ≥ 1)

  During a standardized intra-operative window, insufflation pressure is lowered from 12 mmHg to 6 mmHg in 1 mmHg steps, with a 60-second equilibration at each step; at each step a 3-second de-identified video clip is scored by 2-3 blinded assessors with the vNOTES-OVI (0/1/2). The consensus (median) score yields, per participant, the lowest pressure at which the field is adequate (OVI ≥ 1). Lower pressure indicates a better field.

  Intra-operative (single measurement window)

Secondary Outcomes (10)

• Continuous surgical-field score (vNOTES-OVI)

  Intra-operative

• Lowest pressure at the strict threshold (vNOTES-OVI = 2)

  Intra-operative

• Requirement for a third working instrument

  Intra-operative

• Postoperative nausea and vomiting - complete response

  0-24 hours postoperative

• Nausea severity

  0-24 hours postoperative

Study Arms (4)

Arm 1 - Control (no diet + standard neuromuscular blockade NMB)

ACTIVE COMPARATOR

Usual care: standard (moderate) neuromuscular blockade (train-of-four 1-2, intermittent bolus) and no dietary restriction. No mechanical bowel preparation.

Drug: Standard (moderate) neuromuscular blockade

Arm 2 - Diet + standard NMB

EXPERIMENTAL

Three-day preoperative low-residue diet with standard (moderate) neuromuscular blockade. No mechanical bowel preparation.

Drug: Standard (moderate) neuromuscular blockade; Other: Preoperative low-residue diet

Arm 3 - Deep NMB (no diet)

EXPERIMENTAL

Deep neuromuscular blockade (post-tetanic count 1-2, continuous infusion) with no dietary restriction. No mechanical bowel preparation.

Drug: Deep Neuromuscular Blockade (NMB)

Arm 4 - Bundle (diet + deep NMB)

EXPERIMENTAL

Three-day low-residue diet AND deep neuromuscular blockade - the combination of interest. No mechanical bowel preparation.

Drug: Deep Neuromuscular Blockade (NMB); Other: Preoperative low-residue diet

Interventions

Deep Neuromuscular Blockade (NMB) DRUG

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

Arm 3 - Deep NMB (no diet); Arm 4 - Bundle (diet + deep NMB)

Standard (moderate) neuromuscular blockade DRUG

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

Arm 1 - Control (no diet + standard neuromuscular blockade NMB); Arm 2 - Diet + standard NMB

Preoperative low-residue diet OTHER

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

Arm 2 - Diet + standard NMB; Arm 4 - Bundle (diet + deep NMB)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead
• Dr. Lutfi Kirdar Kartal Training and Research Hospital: collaborator
• Kutahya City Hospital: collaborator
• Kocaeli City Hospital: collaborator

Study Sites (3)

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Istanbul, KARTAL, 34865, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Acibadem Kartal Hospital

Istanbul, KARTAL, Turkey (Türkiye)

RECRUITING

Kütahya Şehir Hastanesi

Kütahya, Kütahya, 43100, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Related Publications (2)

• Yassa M, Karadeniz O, Kaya C, Doğan O, Şentürk B, Çalışkan E. Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Hysterectomy in Benign Gynecologic Indications: Evidence-Based Recommendations of the Pelvic Floor and Cosmetic Gynecology (PETKOZ) Association, Combined with Expert Consensus - A National Guideline. Anat J Obstet Gynecol Res. 2026 May 13;3(1):1-20. doi: 10.4274/anajog.galenos.2026.06078. Epub 2026 May 8.

  BACKGROUND

• Yassa M, Kaya C, Kalafat E, Tekin AB, Karakas S, Mutlu MA, Birol P, Tug N. The Comparison of Transvaginal Natural Orifice Transluminal Endoscopic Surgery and Conventional Laparoscopy in Opportunistic Bilateral Salpingectomy for Permanent Female Sterilization. J Minim Invasive Gynecol. 2022 Feb;29(2):257-264.e1. doi: 10.1016/j.jmig.2021.08.009. Epub 2021 Aug 16.

  PMID: 34411729 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Metrorrhagia; Uterine Prolapse; Adenomyosis; Pneumoperitoneum

Interventions

Neuromuscular Blockade

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Investigative Techniques

Central Study Contacts

MURAT Y Murat Yassa, MD (Assoc. Prof.) - Principal Investigator, ASSOCIATE PROFESSOR IN OBS GYN

CONTACT

+905335106312; murat.yassa@acibadem.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department

Model Details: 2×2 factorial: Factor A = neuromuscular-blockade depth (deep vs standard); Factor B = preoperative low-residue diet (yes vs no). Four equal groups; no mechanical bowel preparation in any group.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 25, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

TU (3)