NCT07758504

Brief Summary

Vaginal natural orifice transluminal endoscopic surgery is recognized as a significant advancement in women's health, representing an extension of minimally invasive surgery. Research and clinical experience with this technique are ongoing, contributing to its increasing adoption as a suitable option for a broader patient population. The aim of this study is to evaluate vaginal natural orifice transluminal endoscopic surgery hysterectomy performed under general anesthesia versus regional anesthesia in terms of surgical comfort, length of hospital stay, postoperative pain, and other relevant clinical outcomes, as well as to compare patients' recovery times.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Oct 2027

Study Start

First participant enrolled

July 14, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2027

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

August 2, 2026

Last Update Submit

August 8, 2026

Conditions

Hysterectomy for Abnormal Uterine Bleeding

Keywords

V-NOTESHYSTERECTOMYSPİNAL ANESTHESİA

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating worse pain.

    Postoperative Visual Analog Scale (VAS) pain score at 24 hour

Study Arms (2)

Spinal Anesthesia Group

EXPERIMENTAL

Participants undergoing v-notes hysterectomy under spinal anesthesia

Procedure: Vnotes hysterectomy under spinal anesthesia

General Anesthesia Group

ACTIVE COMPARATOR

participants undergoing v-notes hysterectomy under general anesthesia

Procedure: Vnotes hysterectomy under general anesthesia

Interventions

Vnotes hysterectomy under spinal anesthesiaPROCEDURE

V-notes hysterectomy performed under spinal anesthesia according to the study protocol

Spinal Anesthesia Group
Vnotes hysterectomy under general anesthesiaPROCEDURE

V-notes hysterectomy performed under general anesthesia according to the study protocol

General Anesthesia Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status classification I-II

You may not qualify if:

  • History of tubo-ovarian abscess
  • Presence or history of deep endometriosis
  • Suspected pelvic adhesions
  • Nodule in the pouch of Douglas
  • Fixed uterus
  • Sexually inactive patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 11, 2026

Study Start

July 14, 2026

Primary Completion (Estimated)

October 10, 2027

Study Completion (Estimated)

October 10, 2027

Last Updated

August 11, 2026

Record last verified: 2026-08