Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy
- Conditions
- Gynecologic Disease
- Interventions
- Procedure: Manipulator-assisted Abdominal Hysterectomy
- Registration Number
- NCT06374940
- Lead Sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 140
- Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications
- Exclusion criteria were patients with additional procedures such as urogynecologic procedures, history of abdominal surgery with midline incision, patients with suspected gynecologic malignancy, endometriosis, tubo-ovarian abscess, pelvic organ prolapse, or those who refused to participate in the study and whose medical records could not be obtained.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manipulator-assisted Abdominal Hysterectomy Manipulator-assisted Abdominal Hysterectomy In manipulator-assisted abdominal hysterectomy tecnique, a uterine manipulator (SecuFix ® , Richard Wolf) was inserted into the cervix. Conventional hysterectomy steps were performed until the vaginal colpotomy incision. A circular colpotomy incision was made directly over the manipulator silicone cup using a monopolar cautery set at 30W cutting mode without interfering with the cardinal ligament or sacrouterine ligament. The vaginal cuff was sutured using polyglactin 910 (no:1) as a single layer running suture.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
intraoperative complications Intraoperative Any minor and major (e.g., bowel injury, bleeding\>300cc, major vessel injury) complications that occur during the surgery
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.
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.
Trial Locations
- Locations (1)
Dr.Lütfi Kırdar City Hospital
🇹🇷Istanbul, Turkey