Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy

Gynecologic Disease Clinical Trial

Official title:

The Comparison of Surgical Outcomes to Conventional Hysterectomy and Manipulator-assisted Abdominal Hysterectomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06374940
• Other study ID #: Lütfi Kirdar City Hospital
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

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