Gynecologic Disease Clinical Trial
Official title:
The Comparison of Surgical Outcomes to Conventional Hysterectomy and Manipulator-assisted Abdominal Hysterectomy
Verified date | April 2024 |
Source | Dr. Lutfi Kirdar Kartal Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Enrolling by invitation |
Enrollment | 140 |
Est. completion date | May 18, 2024 |
Est. primary completion date | May 17, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: - Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Dr.Lütfi Kirdar City Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Dr. Lutfi Kirdar Kartal Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of the surgical procedure | 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 | intraoperative | |
Secondary | Postoperative pain at 6th hours | 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. | At the 6th hours after the surgical procedure | |
Secondary | Postoperative pain at 24th hours | 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. | At the 24th hours after the surgical procedure | |
Secondary | intraoperative complications | Any minor and major (e.g., bowel injury, bleeding>300cc, major vessel injury) complications that occur during the surgery | Intraoperative | |
Secondary | Postoperative complications | 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. | Postoperative, in the first month of the surgery |
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