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2-D and 3-D Laparoscopic Hysterectomy

Primary Purpose

Fibroma, Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3-D laparoscopy
2-D laparoscopy
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibroma, Bleeding focused on measuring Imaging, Three-Dimensional, Hysterectomy, laparoscopic hysterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sjaellands Univercety HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2-Dimensional laparoscopic hysterectomy

3-Dimensional laparoscopic hysterectomy

Arm Description

traditional 2-D laparoscopy

experimental 3-D laparoscopy

Outcomes

Primary Outcome Measures

Score on SF 36 psychical health survey 6 weeks after surgery
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.

Secondary Outcome Measures

Major complications during the operation, postoperative complications
Minor complications during the operation, postoperative complications
Score on SF 36 mental health survey 6 weeks after surgery
Length of hospital stay
Operative time

Full Information

First Posted
November 16, 2015
Last Updated
April 1, 2018
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02610985
Brief Title
2-D and 3-D Laparoscopic Hysterectomy
Official Title
3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroma, Bleeding
Keywords
Imaging, Three-Dimensional, Hysterectomy, laparoscopic hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2-Dimensional laparoscopic hysterectomy
Arm Type
Active Comparator
Arm Description
traditional 2-D laparoscopy
Arm Title
3-Dimensional laparoscopic hysterectomy
Arm Type
Experimental
Arm Description
experimental 3-D laparoscopy
Intervention Type
Device
Intervention Name(s)
3-D laparoscopy
Intervention Description
3-D laparoscopy
Intervention Type
Device
Intervention Name(s)
2-D laparoscopy
Intervention Description
2-D laparoscopy
Primary Outcome Measure Information:
Title
Score on SF 36 psychical health survey 6 weeks after surgery
Time Frame
6 weeks
Title
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Major complications during the operation, postoperative complications
Time Frame
6 weeks
Title
Minor complications during the operation, postoperative complications
Time Frame
6 weeks
Title
Score on SF 36 mental health survey 6 weeks after surgery
Time Frame
6 weeks
Title
Length of hospital stay
Time Frame
6 weeks
Title
Operative time
Time Frame
4 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Hoffmann, MD
Phone
+45 20252017
Email
elisehoffmann78@gmail.com
Facility Information:
Facility Name
Sjaellands Univercety Hospital
City
Roskilde
State/Province
Zealand
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Hoffmann, MD
Phone
20252017
Email
elisehoffmann78@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
28882141
Citation
Hoffmann E, Bennich G, Larsen CR, Lindschou J, Jakobsen JC, Lassen PD. 3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial. BMC Womens Health. 2017 Sep 7;17(1):76. doi: 10.1186/s12905-017-0434-7.
Results Reference
derived

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2-D and 3-D Laparoscopic Hysterectomy

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