Leiomyoma, UterinevNOTES_NMBDIETNCT07730970
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
A study testing Deep Neuromuscular Blockade (NMB), Standard (moderate) neuromuscular blockade and Preoperative low-residue diet in people with Leiomyoma, Uterine and Benign Gynecological Disease, run by Fatih Sultan Mehmet Training and Research Hospital at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyoma, Uterine, Benign Gynecological Disease, Abnormal Uterine Bleeding (AUB)
- What is being tested?
- Deep Neuromuscular Blockade (NMB), Standard (moderate) neuromuscular blockade and Preoperative low-residue diet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
MURAT Y Murat Yassa, MD (Assoc. Prof.) - Principal Investigator, ASSOCIATE PROFESSOR IN OBS GYN contact
Turkey (Türkiye)3 sites, 1 recruiting
- Active, not recruiting
Kartal Dr. Lütfi Kırdar Şehir Hastanesi
Istanbul, KARTAL, 34865
- Recruiting
Acibadem Kartal Hospital
Istanbul, KARTAL
MURAT Y Murat Yassa, MD - Principal Investigator, MD, Assoc. Prof., +905335106312, murat.yassa@acibadem.com
- Active, not recruiting
Kütahya Şehir Hastanesi
Kütahya, Kütahya, 43100
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Leiomyoma, Uterine, Benign Gynecological Disease, Abnormal Uterine Bleeding (AUB), Uterine Prolapse, Adenomyosis of Uterus
- Being tested
- Deep Neuromuscular Blockade (NMB), Standard (moderate) neuromuscular blockade, Preoperative low-residue diet
- 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
- Medical subject headings
- Leiomyoma, Metrorrhagia, Uterine Prolapse, Adenomyosis, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 blockadeDrug
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 dietOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Deep Neuromuscular Blockade (NMB); Other: Preoperative low-residue diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-operative (single measurement window)
Secondary outcomes (10)
Continuous surgical-field score (vNOTES-OVI)
Blinded vNOTES-OVI (0/1/2) at each insufflation-pressure step, analysed as a threshold-free ordinal/continuous measure.
Measured: Intra-operative
Lowest pressure at the strict threshold (vNOTES-OVI = 2)
Lowest insufflation pressure at which the field is perfectly exposed (OVI = 2), blinded scoring.
Measured: Intra-operative
Requirement for a third working instrument
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).
Measured: Intra-operative
Postoperative nausea and vomiting - complete response
Proportion of participants with no nausea AND no vomiting AND no rescue antiemetic during the first 24 hours.
Measured: 0-24 hours postoperative
Nausea severity
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.
Measured: 0-24 hours postoperative
Vomiting episodes
Number of vomiting/retching episodes during the first 24 hours.
Measured: 0-24 hours postoperative
Operative time
Skin-to-skin operating time.
Measured: Through surgery completion
Estimated blood loss
Estimated intra-operative blood loss (mL).
Measured: Through surgery completion
Conversion to another approach
Conversion to conventional laparoscopy or laparotomy (yes/no).
Measured: Intra-operative
Intra-operative and early postoperative complications
Complications recorded as counts by group.
Measured: hrough 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Jul 2026
- Primary completion25 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Leiomyoma, UterineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kutahya City Hospital, Kocaeli City Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Responsible party
- Principal investigator, MURAT YASSA, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730970
- Sponsor's protocol ID
- ATADEK 2026/12, 2026-12/513
- Acronym
- vNOTES_NMBDIET
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing IPD is curretly under restriction without health ministry's official permisson.
Publications
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.
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.
PubMed 34411729
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07730970
- Acronym / sponsor ID
- vNOTES_NMBDIET / ATADEK 2026/12, 2026-12/513
- Conditions
- Leiomyoma, Uterine, Benign Gynecological Disease, Abnormal Uterine Bleeding (AUB), Uterine Prolapse, Adenomyosis of Uterus
- Keywords
- vNOTES, vaginal natural orifice transluminal endoscopic surgery, deep neuromuscular blockade, rocuronium, post-tetanic count, low-residue diet, bowel preparation, insufflation pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Collaborators
- Kutahya City Hospital, Kocaeli City Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 25 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Control (no diet + standard neuromuscular blockade NMB) | Active comparator | Drug: Standard (moderate) neuromuscular blockadeUsual care: standard (moderate) neuromuscular blockade (train-of-four 1-2, intermittent bolus) and no dietary restriction. No mechanical bowel preparation. |
| Arm 2 - Diet + standard NMB | Experimental | Drug: Standard (moderate) neuromuscular blockade, Other: Preoperative low-residue dietThree-day preoperative low-residue diet with standard (moderate) neuromuscular blockade. No mechanical bowel preparation. |
| Arm 3 - Deep NMB (no diet) | Experimental | Drug: Deep Neuromuscular Blockade (NMB)Deep neuromuscular blockade (post-tetanic count 1-2, continuous infusion) with no dietary restriction. No mechanical bowel preparation. |
| Arm 4 - Bundle (diet + deep NMB) | Experimental | Drug: Deep Neuromuscular Blockade (NMB), Other: Preoperative low-residue dietThree-day low-residue diet AND deep neuromuscular blockade - the combination of interest. No mechanical bowel preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Neuromuscular Blockade (NMB)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 | Drug | Arm 3 - Deep NMB (no diet), Arm 4 - Bundle (diet + deep NMB) |
| Standard (moderate) neuromuscular blockadeRocuronium 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 | Drug | Arm 1 - Control (no diet + standard neuromuscular blockade NMB), Arm 2 - Diet + standard NMB |
| Preoperative low-residue dietA 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 | Other | Arm 2 - Diet + standard NMB, Arm 4 - Bundle (diet + deep NMB) |
Primary outcome
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.
10 secondary outcomes
Continuous surgical-field score (vNOTES-OVI)
Time frame: Intra-operative
Lowest pressure at the strict threshold (vNOTES-OVI = 2)
Time frame: Intra-operative
Requirement for a third working instrument
Time frame: Intra-operative
Postoperative nausea and vomiting - complete response
Time frame: 0-24 hours postoperative
Nausea severity
Time frame: 0-24 hours postoperative
Vomiting episodes
Time frame: 0-24 hours postoperative
Operative time
Time frame: Through surgery completion
Estimated blood loss
Time frame: Through surgery completion
Conversion to another approach
Time frame: Intra-operative
Intra-operative and early postoperative complications
Time frame: hrough 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- BackgroundYassa 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: PubMed 34411729Yassa 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.
- Individual participant dataSharing planned: Undecided. Sharing IPD is curretly under restriction without health ministry's official permisson.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MURAT Y Murat Yassa, MD (Assoc. Prof.) - Principal Investigator, ASSOCIATE PROFESSOR IN OBS GYN contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Neuromuscular Blockade (NMB), Standard (moderate) neuromuscular blockade and Preoperative low-residue diet in people with Leiomyoma, Uterine and Benign Gynecological Disease, run by Fatih Sultan Mehmet Training and Research Hospital at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MURAT Y Murat Yassa, MD (Assoc. Prof.) - Principal Investigator, ASSOCIATE PROFESSOR IN OBS GYN (+905335106312, murat.yassa@acibadem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07730970, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.