Gynecologic Disease
Conditions
Keywords
Hysterectomy, Manipulator-assisted abdominal hysterectomy
Brief summary
Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope. Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications. Primary outcomes: (1) Operation Time. Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications
Interventions
PROCEDUREManipulator-assisted Abdominal Hysterectomy
Manipulator-assisted Abdominal Hysterectomy
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the surgical procedure | intraoperative | The surgical operative time was defined as the time from incision to completion of wound closure, also known as 'cut-to-close' time. In the manipulator-assisted abdominal hysterectomy group, the time of uterine manipulator placement was added to the operation time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain at 6th hours | At the 6th hours after the surgical procedure | Postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain. |
| Postoperative pain at 24th hours | At the 24th hours after the surgical procedure | postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain. |
| intraoperative complications | Intraoperative | Any minor and major (e.g., bowel injury, bleeding\>300cc, major vessel injury) complications that occur during the surgery |
| Postoperative complications | Postoperative, in the first month of the surgery | Any minor and major complications (e.g., bowel injury, haematoma, infection, dyspareunia, vaginal pain, sexual discomfort) that occur in the first month of the surgery. |
Countries
Turkey (Türkiye)
Outcome results
None listed