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CompletedNCT02371811Updated Aug 1, 2017

Use of v Care in Abdominal Hysterectomy

An interventional study of uterine manipulator (v care) in Uterine Fibroid, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by Ain Shams Maternity Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Uterine Fibroid

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03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's enrollment of 60 is close to the median of 62 across 345 interventional studies indexed under Leiomyoma.

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Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • benign causes for hysterectomy

Exclusion criteria

Exclusion Criteria:

  • malignant causes for hysterectomy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    v care group

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

    Device: uterine manipulator (v care)

  • No intervention
    control group

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

Interventions

  • Deviceuterine manipulator (v care)

    Also known as: v care

06

What researchers measure

Primary outcomes

  1. Vaginal length

    Time frame: within 1 week postoperative

Secondary outcomes

  1. Bladder injury

    Time frame: within 1 week postoperative

07

Study locations

1 site
  • Ain Shams Maternity Hospital
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02371811
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
dr mohammed elsafty (consultant, Ain Shams Maternity Hospital) — Principal investigator
First posted
Feb 26, 2015
Start date
Feb 2016
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Aug 1, 2017

Study contacts

mohammed elsafty, md
principal investigator · Ain Shams University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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