Overview

This trial is active, not recruiting.

Condition uterine fibroid
Treatment uterine manipulator (v care)
Phase phase 0
Sponsor Ain Shams Maternity Hospital
Start date February 2016
End date February 2017
Trial size 60 participants
Trial identifier NCT02371811, m2491

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
In this group we will use (v care) uterine manipulator during abdominal hysterectomy.
uterine manipulator (v care) v care
(No Intervention)
In this group we will do abdominal hysterectomy without v care.

Primary Outcomes

Measure
Vaginal length
time frame: within 1 week postoperative

Secondary Outcomes

Measure
Bladder injury
time frame: within 1 week postoperative

Eligibility Criteria

Female participants from 20 years up to 80 years old.

Inclusion Criteria: - benign causes for hysterectomy Exclusion Criteria: - malignant causes for hysterectomy

Additional Information

Principal investigator mohammed elsafty, md
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Ain Shams Maternity Hospital.