NCT02610985

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

April 3, 2018

Status Verified

April 1, 2018

Enrollment Period

2.2 years

First QC Date

November 16, 2015

Last Update Submit

April 1, 2018

Conditions

Fibroma, Bleeding

Keywords

Imaging, Three-DimensionalHysterectomylaparoscopic hysterectomy

Outcome Measures

Primary Outcomes (2)

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

    6 weeks

  • 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 Outcomes (5)

  • Major complications during the operation, postoperative complications

    6 weeks

  • Minor complications during the operation, postoperative complications

    6 weeks

  • Score on SF 36 mental health survey 6 weeks after surgery

    6 weeks

  • Length of hospital stay

    6 weeks

  • Operative time

    4 hours

Study Arms (2)

2-Dimensional laparoscopic hysterectomy

ACTIVE COMPARATOR

traditional 2-D laparoscopy

Device: 2-D laparoscopy

3-Dimensional laparoscopic hysterectomy

EXPERIMENTAL

experimental 3-D laparoscopy

Device: 3-D laparoscopy

Interventions

3-D laparoscopyDEVICE

3-D laparoscopy

3-Dimensional laparoscopic hysterectomy
2-D laparoscopyDEVICE

2-D laparoscopy

2-Dimensional laparoscopic hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sjaellands Univercety Hospital

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28882141DERIVED

MeSH Terms

Conditions

FibromaHemorrhage

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Elise Hoffmann, MD

CONTACT

+45 20252017elisehoffmann78@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 20, 2015

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Last Updated

April 3, 2018

Record last verified: 2018-04

Locations

DK(1)