An observational study in Vnotes and Respiratory Mechanics, sponsored by Burcu Ayvazoğlu. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Burcu Ayvazoğlu · Observational
The purpose of this observational study is to evaluate the effects of Trendelenburg positioning and pneumoperitoneum on mechanical power and respiratory mechanics in adult women undergoing vaginal natural orifice transluminal endoscopic surgery (vNOTES) for bilateral tubal ligation.
The main questions this study aims to answer are:
Participants who are already scheduled to undergo vNOTES bilateral tubal ligation as part of their routine medical care will receive standard general anesthesia and mechanical ventilation. Researchers will record mechanical power and respiratory parameters at six predefined time points during surgery, before and after the application of pneumoperitoneum and Trendelenburg positioning.
A total of 14 adult women will be included. No additional experimental treatment or intervention will be performed as part of the study.
Burcu Ayvazoğlu is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of 14 adult female patients aged 18 years or older who are scheduled to undergo elective bilateral tubal ligation using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique at Yahyali State Hospital, Kayseri, Türkiye.
Eligible participants will have an American Society of Anesthesiologists (ASA) physical status of I-III and will undergo general anesthesia with endotracheal intubation and controlled mechanical ventilation.
Participants will be recruited prospectively from patients scheduled for elective vNOTES surgery. All patients will receive standard surgical and anesthetic care without any study-specific intervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will include 14 adult female patients undergoing elective bilateral tubal ligation using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique under general anesthesia with controlled mechanical ventilation. All participants will receive standard surgical and anesthetic care. Trendelenburg positioning and pneumoperitoneum will be performed as part of the routine surgical procedure. Mechanical power and respiratory mechanics parameters will be recorded at six predefined intraoperative time points to evaluate changes associated with Trendelenburg positioning and pneumoperitoneum. No additional experimental intervention or modification of routine clinical care will be performed.
Changes in Intraoperative Mechanical Power During vNOTES Surgery
Mechanical power (J/min) will be calculated using recorded mechanical ventilation parameters. Changes in mechanical power associated with pneumoperitoneum and Trendelenburg positioning will be evaluated at six predefined intraoperative time points (T0-T5). Kopyala
Time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Changes in Intraoperative Driving Pressure
Description: Driving pressure (cmH₂O) will be calculated as plateau pressure minus positive end-expiratory pressure (Pplat - PEEP).
Time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Changes in Static Respiratory System Compliance
Static respiratory system compliance (mL/cmH₂O) will be calculated using tidal volume and driving pressure (VT/\[Pplat - PEEP\]).
Time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Changes in Dynamic Respiratory System Compliance
Dynamic respiratory system compliance (mL/cmH₂O) will be calculated using tidal volume and the difference between peak airway pressure and PEEP (VT/\[Ppeak - PEEP\]).
Time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Burcu Ayvazoğlu