NCT02059954

Brief Summary

Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing. This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

February 10, 2014

Last Update Submit

April 16, 2018

Conditions

Uterine FibroidsUterine LeiomyomaAbnormal Uterine Bleeding, Unspecified

Keywords

Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Operating time (min.)

    Operating time (min.)

    Surgery

Secondary Outcomes (5)

  • Complications

    6 weeks

  • Anesthesia time (min.)

    surgery

  • Quality of life

    12 months

  • Sexual health

    12 months

  • Return to work

    3 months

Study Arms (2)

Vaginal hysterectomy

ACTIVE COMPARATOR

Vaginal hysterectomy

Procedure: Hysterectomy

Total laparoscopic hysterectomy

ACTIVE COMPARATOR

Laparoscopic hysterectomy

Procedure: Hysterectomy

Interventions

HysterectomyPROCEDURE
Total laparoscopic hysterectomyVaginal hysterectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia)
  • clinical exam indicates vaginal hysterectomy is feasible
  • no major concomitant surgery
  • able to complete questionnaires in German

You may not qualify if:

  • uterine malignancy
  • major concomitant surgery (e.g., for incontinence or prolapse)
  • clinical exam indicating vaginal hysterectomy not feasible
  • contraindication for surgery or laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie

Graz, 8020, Austria

Location

Medical University of Graz/Dept. OB/GYN

Graz, 8036, Austria

Location

LKH Leoben/Abteilung Gynäkologie

Leoben, 8700, Austria

Location

MeSH Terms

Conditions

LeiomyomaMyofibromaMetrorrhagia

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueConnective Tissue DiseasesSkin and Connective Tissue DiseasesUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Karl F Tamussino, MD

    Medical University of Graz

    STUDY CHAIR

  • Rene W Laky, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 11, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

September 1, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

AU(3)