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Prospective Multicenter Cohort Study of Vaginal Natural Orifice Transluminal Surgery (vNOTES) for Benign Gynecologic Diseases

Prospective Multicenter Cohort Study of Vaginal Natural Orifice Transluminal Surgery (vNOTES) for Benign Gynecologic Diseases

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005139
Enrollment
30
Registered
2020-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Vaginal Natural Orifice Transluminal Endoscopic Surgery is performed on patients with benign gynecologic diseases such as adenomyosis and myoma. The vNOTES surgery is application o

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Adult women, between 19 to 80 years of age 2) Patients whom lithotomy position and vaginal approach is possible 3) For patients aged 70 or more, patients who voluntarily agreed to consent form; patients unable to sit in lithotomy position or unable to approach vaginally in surgical field is excluded. 4) Patients suitable for surgery (American society of Anesthesiologists Physical Status classification 1 or 2) 5) Patients who understand the contents of the study and able to participate till the end 6) Patients who signed the consent form voluntarily

Exclusion criteria

Exclusion criteria: 1) Patients underaged or age over 80 2) Pregnant women, or lactating women 3) Patiens without prior sexual intercourse 4) Patients unable to sit in lithotomy position 5) Patients whom pelvic malignancy is suspected 6) Patients who underwent cesarean section twice or more 7) Patients whose posterior-cul-de-sac obliteration is suspected on bimanual pelvic exam 8) Patients who did not sign the consent form 9) Patients whom investigators decided is not suitable for the study or unable to complete the study for any reasons

Design outcomes

Primary

MeasureTime frame
Patients who successfully underwent vNOTES surgery

Secondary

MeasureTime frame
Operation related variables: Operation time, time from vaginal incision to vNOTES port setup, adhesion during surgery, type of port used, conversion to other methods, transfusion, bleeding amount, ICU admission;Variables during admission: Admission period, pain score after surgery in 8 hour intervals, NSAID or opioids use (intravenous), Postoperative complication (fever, urination difficulty, defecation difficulty, vaginal stump rulture, urinary tract injury, vascular injury), Hemoglobin level at postoperative day 1;Variables within three months: Reoperation, Readmission, Pathologic data

Countries

Korea, Republic of

Contacts

Public ContactHaerin Paik

Seoul National University Hospital

haerin.paik@gmail.com+82-2-2072-2388

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026