NCT02371811

Brief Summary

The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 17, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

February 17, 2015

Last Update Submit

July 30, 2017

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

  • Vaginal length

    within 1 week postoperative

Secondary Outcomes (1)

  • Bladder injury

    within 1 week postoperative

Study Arms (2)

v care group

EXPERIMENTAL

In this group we will use (v care) uterine manipulator during abdominal hysterectomy.

Device: uterine manipulator (v care)

control group

NO INTERVENTION

In this group we will do abdominal hysterectomy without v care.

Interventions

uterine manipulator (v care)DEVICE
Also known as: v care
v care group

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • benign causes for hysterectomy

You may not qualify if:

  • malignant causes for hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • mohammed elsafty, md

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 26, 2015

Study Start

February 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

EG(1)