Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy

Not Applicable

• Conditions: Gynecologic Disease

• 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

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study Start: 2024-04-17
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-05-17
• Study Completion: 2024-05-18

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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