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NCT Number: NCT07730970

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

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)

    Time frame: 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.

Secondary outcomes

  1. Continuous surgical-field score (vNOTES-OVI)

    Time frame: Intra-operative

    Blinded vNOTES-OVI (0/1/2) at each insufflation-pressure step, analysed as a threshold-free ordinal/continuous measure.

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

    Time frame: Intra-operative

    Lowest insufflation pressure at which the field is perfectly exposed (OVI = 2), blinded scoring.

  3. Requirement for a third working instrument

    Time frame: 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).

  4. Postoperative nausea and vomiting - complete response

    Time frame: 0-24 hours postoperative

    Proportion of participants with no nausea AND no vomiting AND no rescue antiemetic during the first 24 hours.

  5. Nausea severity

    Time frame: 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.

  6. Vomiting episodes

    Time frame: 0-24 hours postoperative

    Number of vomiting/retching episodes during the first 24 hours.

  7. Operative time

    Time frame: Through surgery completion

    Skin-to-skin operating time.

  8. Estimated blood loss

    Time frame: Through surgery completion

    Estimated intra-operative blood loss (mL).

  9. Conversion to another approach

    Time frame: Intra-operative

    Conversion to conventional laparoscopy or laparotomy (yes/no).

  10. Intra-operative and early postoperative complications

    Time frame: hrough 24 hours postoperative

    Complications recorded as counts by group.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+905335106312

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital
  • Kocaeli City Hospital
  • Kutahya City Hospital

Registry information

Official study title

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

Acronym: vNOTES_NMBDIET

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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