NCT06374940

Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital · Other Government
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gynecologic Disease

Interventions

Type	Name	Description
PROCEDURE	Manipulator-assisted Abdominal Hysterectomy	Manipulator-assisted Abdominal Hysterectomy

Timeline

• Start date: 2024-04-17
• Primary completion: 2024-05-17
• Completion: 2024-05-18
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: Turkey (Türkiye)