Vaginal vs. Laparoscopic Hysterectomy | NCT02059954

Studies
Vaginal vs. Laparoscopic Hysterectomy

NCT02059954

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Apr 17, 2018Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Uterine Fibroids
Uterine Leiomyoma
Abnormal Uterine Bleeding, Unspecified

Interventions

Hysterectomy

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MUG 26-122 ex 13/14	Other Identifier	MUGraz

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Sep 2017Actual

First Submitted Date

Feb 10, 2014

First Submission Date that Met QC Criteria

Feb 10, 2014

First Posted Date

Feb 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 17, 2018Actual

Name	Class
Austrian Urogynecology Working Group (AUWG)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal hysterectomy	Active Comparator	Vaginal hysterectomy	Procedure: Hysterectomy
Total laparoscopic hysterectomy	Active Comparator	Laparoscopic hysterectomy	Procedure: Hysterectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hysterectomy	Procedure		Total laparoscopic hysterectomy Vaginal hysterectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operating time (min.)	Operating time (min.)	Surgery

Secondary Outcomes

Measure	Description	Time Frame
Complications	Intraoperative and postoperative complications	6 weeks
Anesthesia time (min.)		surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl F Tamussino, MD	Medical University of Graz	Study Chair
Rene W Laky, MD	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie		Graz		8020	Austria
Medical University of Graz/Dept. OB/GYN

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma
D047708	Myofibroma
D008796	Metrorrhagia

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007044	Hysterectomy

Ancestor Terms

ID	Term
D013509	Gynecologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided