- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07730970
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy (vNOTES_NMBDIET)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: MURAT Y Murat Yassa, MD (Assoc. Prof.) - Principal Investigator, ASSOCIATE PROFESSOR IN OBS GYN
- Telefonní číslo: +905335106312
- E-mail: murat.yassa@acibadem.com
Studijní místa
-
-
KARTAL
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Istanbul, KARTAL, Turecko (Türkiye), 34865
- Aktivní, ne nábor
- Kartal Dr. Lütfi Kırdar Şehir Hastanesi
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Istanbul, KARTAL, Turecko (Türkiye)
- Nábor
- Acibadem Kartal Hospital
-
Kontakt:
- MURAT Y Murat Yassa, MD - Principal Investigator, MD, Assoc. Prof.
- Telefonní číslo: +905335106312
- E-mail: murat.yassa@acibadem.com
-
-
Kütahya
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Kütahya, Kütahya, Turecko (Türkiye), 43100
- Aktivní, ne nábor
- Kütahya Şehir Hastanesi
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Aktivní komparátor: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Lowest CO₂ insufflation pressure at which the surgical field is adequate (blinded Transvaginal Natural Orifice Endoluminal Surgery - Objectiveisual Index: vNOTES-OVI ≥ 1)
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Continuous surgical-field score (vNOTES-OVI)
Časové okno: 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)
Časové okno: Intra-operative
|
Lowest insufflation pressure at which the field is perfectly exposed (OVI = 2), blinded scoring.
|
Intra-operative
|
|
Requirement for a third working instrument
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 0-24 hours postoperative
|
Number of vomiting/retching episodes during the first 24 hours.
|
0-24 hours postoperative
|
|
Operative time
Časové okno: Through surgery completion
|
Skin-to-skin operating time.
|
Through surgery completion
|
|
Estimated blood loss
Časové okno: Through surgery completion
|
Estimated intra-operative blood loss (mL).
|
Through surgery completion
|
|
Conversion to another approach
Časové okno: Intra-operative
|
Conversion to conventional laparoscopy or laparotomy (yes/no).
|
Intra-operative
|
|
Intra-operative and early postoperative complications
Časové okno: hrough 24 hours postoperative
|
Complications recorded as counts by group.
|
hrough 24 hours postoperative
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- příprava střev
- pneumoperitoneum
- rokuronium
- vPOZNÁMKY
- hlubokou neuromuskulární blokádu
- faktoriální soud
- chirurgické pole
- vizualizace
- transluminální endoskopická chirurgie s přirozeným vaginálním otvorem
- nízkozbytková dieta
- Neuspokojivý tlak
- post-tetanic count
- objective visualisation index (OVI)
- assessor-blinded
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Patologické procesy
- Novotvary
- Patologické stavy, anatomické
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Novotvary podle histologického typu
- Nemoci trávicího systému
- Onemocnění dělohy
- Onemocnění pohlavních orgánů, ženy
- Krvácení
- Novotvary, pojivové a měkké tkáně
- Peritoneální onemocnění
- Novotvary, svalová tkáň
- Děložní krvácení
- Prolaps pánevních orgánů
- Výhřez
- Patologické stavy, příznaky a symptomy
- Adenomyóza
- Pneumoperitoneum
- Leiomyom
- Prolaps dělohy
- Metrorrhagie
- Vyšetřovací techniky
- Anestezie a analgezie
- Neuromuskulární blokáda
Další identifikační čísla studie
- ATADEK 2026/12, 2026-12/513
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