Skip to content

Vaginal natural orifice transluminal endoscopic surgery vs. single port assess for hysterectomy

Vaginal natural orifice transluminal endoscopic surgery vs. single port assess for hysterectomy: a randomized pilot study (VANILLA trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0004605
Enrollment
26
Registered
2020-01-07
Start date
2020-02-13
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 : single port assisted hysterectomy will be done to patients in control group, while VNOTES hysterectomy will be done to experimental group patients. In the case vaginal approach is

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Informed consent 2) Age: 19-80 years old 3) Diseases require hysterectomy (benign uterine mass, abnormal uterine bleeding, etc.) 4) Eligible for endoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2) 5) Understanding the contents of the study, proper compliance, ability to participate to the end of the trial

Exclusion criteria

Exclusion criteria: 1) Pregnancy or breastfeeding 2) Virgin 3) Suspicion for pelvic malignancy 4) Previous cesarean section for three times or more 5) Suspicion for posterior cul-de-sac obliteration by vaginal examination 6) Inappropriate patients by the researcher's decision

Design outcomes

Primary

MeasureTime frame
Postoperative pain

Secondary

MeasureTime frame
Length of hospitalization;Estimated blood loss (intraoperiatve, postoperative);Postoperative hemoglobin drop;Duration of surgery;pelvic fluid collection;Postoperative complication;Reoperation within 6 months after surgery;Postoperative pain

Countries

Korea, Republic of

Contacts

Public ContactSoo Jin Park

Seoul National University Hospital

soojin.mdpark@gmail.com+82-2-2072-2388

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 14, 2026