0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse

NCT ID: NCT04078802

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2020-11-30

Brief Summary

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VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.

Detailed Description

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The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.

Conditions

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Vaginal Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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VNOTES ARM

treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.

Group Type EXPERIMENTAL

VNOTES/VH

Intervention Type PROCEDURE

same as above

Vaginal hysterectomy Arm

treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.

Group Type EXPERIMENTAL

VNOTES/VH

Intervention Type PROCEDURE

same as above

Interventions

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VNOTES/VH

same as above

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women with vaginal prolapse
* capable of having a surgery - assessed by an anesthesiologist
* women who approve of having the surgery

Exclusion Criteria

* BMI over 40
* women who have recurrent PID (pelvic inflammatory disease)
* women with oncology records
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Omer MOR MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omer Mor, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Central Contacts

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Omer Mor, mD

Role: CONTACT

972546486414

Other Identifiers

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RambamMD

Identifier Type: -

Identifier Source: org_study_id

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