3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial

Area of Science:

• Minimally Invasive Surgery
• Gynecologic Surgery
• Surgical Technology

Background:

• Hysterectomy is a common procedure for women of reproductive age.
• Laparoscopic hysterectomy is a recommended surgical approach.
• 3-dimensional (3D) laparoscopy has shown potential for reduced operative time compared to conventional laparoscopy in observational studies.

Purpose of the Study:

• To determine if 3D laparoscopy improves quality of life after benign hysterectomy compared to conventional laparoscopy.
• To assess if 3D laparoscopy leads to less postoperative pain, fewer complications, and shorter recovery times.
• To compare operative time and hospital stay between 3D and conventional laparoscopic hysterectomy.

Main Methods:

• A randomized multicentre clinical trial involving 400 women undergoing laparoscopic hysterectomy for benign indications.
• Participants are randomized to either 3D or conventional laparoscopic hysterectomy.
• Primary outcomes include quality of life (SF-36 questionnaire) and postoperative pain (Visual Analogue Scale). Secondary outcomes include operative time, return to work, hospital stay, and complications.

Main Results:

• This section is not yet available as the study is ongoing or results have not been published.
• The study aims to provide robust data on the comparative effectiveness of 3D versus conventional laparoscopy.
• Sample size calculation indicates 190 patients per arm are needed to detect significant differences.

Conclusions:

• This will be the first randomized clinical trial comparing 3D to conventional laparoscopy for benign hysterectomy.
• Results will inform the future role of 3D laparoscopy in gynecologic surgery.
• The study may influence surgical practice and patient outcomes in laparoscopic hysterectomy.