2-D and 3-D Laparoscopic Hysterectomy

Fibroma, Bleeding Clinical Trial

Official title:

3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02610985
• Other study ID #: 2D/3D hysterectomy
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2015
• Last updated: April 1, 2018
• Start date: September 2016

Study information

• Verified date: April 2018
• Source: Zealand University Hospital
• Contact: Elise Hoffmann, MD
• Phone: +45 20252017
• Email: elisehoffmann78[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background:

No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.

Objective:

To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time.

Design:

Investigator-initiated, blinded, randomised controlled trial.

Intervention description:

Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D.

Trial size Roskilde/Herlev Hospital, Denmark:

200 patients in each arm of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients referred for laparoscopic hysterectomy with or without bilateral salpingectomy or bilateral salpingooophorectomy for benign indications.

Exclusion Criteria:

• Women not suitable for laparoscopic hysterectomy including:

• Ultrasound appraisal of uterus weight > 1000 gram

• Need for prolapse surgery and therefore indication for vaginal hysterectomy.

• Inability to give informed consent

Related Conditions & MeSH terms

• Fibroma
• Fibroma, Bleeding

Intervention

Device:
• 3-D laparoscopy
3-D laparoscopy
• 2-D laparoscopy
2-D laparoscopy

Locations

Country	Name	City	State
Denmark	Sjaellands Univercety Hospital	Roskilde	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on SF 36 psychical health survey 6 weeks after surgery		6 weeks
Primary	Pain (VAS score) assessed immediately at return to the gynaecological unit (about 5 hours postoperatively) and (VAS score) in the morning days 1-3 postoperatively.		3 days
Secondary	Major complications during the operation, postoperative complications		6 weeks
Secondary	Minor complications during the operation, postoperative complications		6 weeks
Secondary	Score on SF 36 mental health survey 6 weeks after surgery		6 weeks
Secondary	Length of hospital stay		6 weeks
Secondary	Operative time		4 hours