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

29. juli 2026 opdateret af: MURAT YASSA, Fatih Sultan Mehmet Training and Research Hospital

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

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.

Studieoversigt

Detaljeret beskrivelse

The field is scored with the vNOTES-OVI, a 3-point index (0 = inadequate, 1 = adequate only with instrument bowel-retraction, 2 = optimal/clear), adapted for vNOTES from the team's prior objective visualisation index in conventional laparoscopy. At each 1 mmHg step a 3-second clip is recorded with a fixed scanning choreography (right adnexa → midline/cephalic boundary → left adnexa); the consensus (median) of the blinded assessors defines, per participant, the lowest pressure at which the field is adequate (OVI ≥ 1; primary) and at which it is optimal (OVI = 2; secondary).

Deep relaxation is rocuronium by continuous infusion to a post-tetanic count of 1-2 (no train-of-four twitches); standard relaxation is rocuronium by intermittent bolus to a train-of-four count of 1-2. Relaxation depth is monitored quantitatively and fully reversed (train-of-four ratio ≥ 0.9 confirmed) before extubation in every participant; the reversal agent is sugammadex in all four groups (neostigmine is not used), and because sugammadex dosing follows block depth (≈ 2 mg/kg moderate, ≈ 4 mg/kg deep) the dose differs by the NMB factor by necessity, so it is recorded per participant and reported by arm (collinear with NMB depth, it is examined only in a sensitivity analysis, not added as a covariate to the factorial nausea model). The step-down field measurement descends from 12 mmHg to 6 mmHg in 1 mmHg steps with a 60-second equilibration at each step. The preoperative low-residue diet (diet arms) restricts daily intake to less than 10 g of dietary fibre for the three days before surgery - permitting refined grains, well-cooked or canned skinless and seedless vegetables, peeled or canned fruit, tender meat, fish, eggs, and moderate dairy, while avoiding whole grains, raw fruits and vegetables, legumes, nuts, seeds, and dried fruit - and participants receive a written diet information sheet; no group receives mechanical bowel preparation. The primary outcome is assessor-blinded (assessors score de-identified video with pressure and group removed); the operating surgeon is blinded to allocation and the data analyst analyses with groups coded; the anaesthesia team is necessarily unblinded to relaxation depth but does not score the outcome. The internal pilot (≈ 10-15 per group) is used for blinded sample-size re-estimation; detecting an interaction typically requires several times the sample size of a main effect.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: MURAT Y Murat Yassa, MD (Assoc. Prof.) - Principal Investigator, ASSOCIATE PROFESSOR IN OBS GYN
  • Telefonnummer: +905335106312
  • E-mail: murat.yassa@acibadem.com

Studiesteder

    • KARTAL
      • Istanbul, KARTAL, Tyrkiet (Türkiye), 34865
        • Aktiv, ikke rekrutterende
        • Kartal Dr. Lütfi Kırdar Şehir Hastanesi
      • Istanbul, KARTAL, Tyrkiet (Türkiye)
        • Rekruttering
        • Acibadem Kartal Hospital
        • Kontakt:
          • MURAT Y Murat Yassa, MD - Principal Investigator, MD, Assoc. Prof.
          • Telefonnummer: +905335106312
          • E-mail: murat.yassa@acibadem.com
    • Kütahya
      • Kütahya, Kütahya, Tyrkiet (Türkiye), 43100
        • Aktiv, ikke rekrutterende
        • Kütahya Şehir Hastanesi

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 2 - Diet + standard NMB
Three-day preoperative low-residue diet with standard (moderate) neuromuscular blockade. No mechanical bowel preparation.

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

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

Eksperimentel: Arm 3 - Deep NMB (no diet)
Deep neuromuscular blockade (post-tetanic count 1-2, continuous infusion) with no dietary restriction. No mechanical bowel preparation.

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

Eksperimentel: Arm 4 - Bundle (diet + deep NMB)
Three-day low-residue diet AND deep neuromuscular blockade - the combination of interest. No mechanical bowel preparation.

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

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

Aktiv komparator: Arm 1 - Control (no diet + standard neuromuscular blockade NMB)
Usual care: standard (moderate) neuromuscular blockade (train-of-four 1-2, intermittent bolus) and no dietary restriction. No mechanical bowel preparation.

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lowest CO₂ insufflation pressure at which the surgical field is adequate (blinded Transvaginal Natural Orifice Endoluminal Surgery - Objectiveisual Index: vNOTES-OVI ≥ 1)
Tidsramme: Intra-operative (single measurement window)
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Continuous surgical-field score (vNOTES-OVI)
Tidsramme: Intra-operative
Blinded vNOTES-OVI (0/1/2) at each insufflation-pressure step, analysed as a threshold-free ordinal/continuous measure.
Intra-operative
Lowest pressure at the strict threshold (vNOTES-OVI = 2)
Tidsramme: Intra-operative
Lowest insufflation pressure at which the field is perfectly exposed (OVI = 2), blinded scoring.
Intra-operative
Requirement for a third working instrument
Tidsramme: Intra-operative
Whether an instrument beyond the camera and the two standard working instruments - introduced through the platform's existing channel, not a new abdominal port - was required solely to expose the field or displace bowel (yes/no per case).
Intra-operative
Postoperative nausea and vomiting - complete response
Tidsramme: 0-24 hours postoperative
Proportion of participants with no nausea AND no vomiting AND no rescue antiemetic during the first 24 hours.
0-24 hours postoperative
Nausea severity
Tidsramme: 0-24 hours postoperative
Worst nausea severity on a 4-point verbal scale (none/mild/moderate/severe), assessed by a blinded assessor at 0-2, 2-6, and 6-24 hours.
0-24 hours postoperative
Vomiting episodes
Tidsramme: 0-24 hours postoperative
Number of vomiting/retching episodes during the first 24 hours.
0-24 hours postoperative
Operative time
Tidsramme: Through surgery completion
Skin-to-skin operating time.
Through surgery completion
Estimated blood loss
Tidsramme: Through surgery completion
Estimated intra-operative blood loss (mL).
Through surgery completion
Conversion to another approach
Tidsramme: Intra-operative
Conversion to conventional laparoscopy or laparotomy (yes/no).
Intra-operative
Intra-operative and early postoperative complications
Tidsramme: hrough 24 hours postoperative
Complications recorded as counts by group.
hrough 24 hours postoperative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2026

Primær færdiggørelse (Anslået)

25. juli 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

22. juli 2026

Først indsendt, der opfyldte QC-kriterier

22. juli 2026

Først opslået (Faktiske)

28. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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