Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy
NCT ID: NCT06374940
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
140 participants
INTERVENTIONAL
2024-04-17
2024-05-18
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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conventional abdominal hysterectomy
The surgical technique of conventional abdominal hysterectomy was described in the literature.
No interventions assigned to this group
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.
Manipulator-assisted Abdominal Hysterectomy
Manipulator-assisted Abdominal Hysterectomy
Interventions
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Manipulator-assisted Abdominal Hysterectomy
Manipulator-assisted Abdominal Hysterectomy
Eligibility Criteria
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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.
40 Years
70 Years
FEMALE
No
Sponsors
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Dr. Lutfi Kirdar Kartal Training and Research Hospital
OTHER_GOV
Responsible Party
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pınar birol ilter
Specialist of obstetrics and gynecology
Locations
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Dr.Lütfi Kırdar City Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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Lütfi Kırdar City Hospital
Identifier Type: -
Identifier Source: org_study_id
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