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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06374940
Other study ID # Lütfi Kirdar City Hospital
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 17, 2024
Est. completion date May 18, 2024

Study information

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

Clinical Trial 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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Manipulator-assisted Abdominal Hysterectomy
Manipulator-assisted Abdominal Hysterectomy

Locations

Country Name City State
Turkey Dr.Lütfi Kirdar City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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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