VNOTES and Vaginal Hysterectomy for Benign Indications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-80
SponsorDr. Lutfi Kirdar Kartal Training and Research Hospital
About this trial
This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions.
A prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Patients aged 40-80 who underwent hysterectomy for benign indications will included. Outcomes will assessed included surgical outcomes, Visual Analog Scale (VAS) pain scores, and complication rates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged between 40 and 80 years
undergo hysterectomy for benign gynecological conditions
Disqualifiers
history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),
suspected gynecologic malignancies,
endometriosis,
tubal-ovarian abscesses,
Trial design
Design model
Parallel
Treatments tested in this trial
vNOTES
Procedure/SurgeryvNOTES for benign hysterectomy
vaginal hysterectomy
Procedure/Surgeryvaginal hysterectomy for benign hysterectomy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: vNOTES hysterectomy for benign indicationsExperimental treatment 1 intervention
Group B: Vaginal hysterectomy for benign indicationsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the duration of surgery
İnterval from initial incision to the completion of vaginal cuff closure (minute)
Time frame
The time from the beginning to the end of the operationSecondary outcomes
1
Hospitalization time
Time from surgery to discharge (hours)
Time frame
through study completion, an average of 1 month2
VAS score
Visual Analog Score for pain at postoperative 6th and 24 th hour (0-10)
Time frame
postoperative 6th and 24 th hour3
Uterin volume
Uterine volume is quantified in milimeters based on measurement of pathological specimens, calculate using the formula (Uterine volume (ml)= (anterior-posterior diameter)\* (sagital diameter) \* (transverse diameter) \* 0,0005236
Time frame
through study completion, an average of 1 month4
Re-admission
Re-admission to hospital after discharge (yes/no)
Time frame
within 1 month after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: