Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair

NCT ID: NCT01398215

Last Updated: 2018-05-01

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

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2019-01-31

Brief Summary

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This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12 months post-op.

Detailed Description

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Conditions

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Umbilical Hernia Ventral Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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transvaginal NOTES

transvaginal NOTES ventral hernia repair

Intervention Type PROCEDURE

ventral hernia repair via the transvaginal approach

Interventions

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transvaginal NOTES ventral hernia repair

ventral hernia repair via the transvaginal approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Umbilical or incisional hernia greater than 2 cm in size
2. Female, age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a transvaginal NOTES ventral hernia repair

Exclusion:

1. Pregnant women
2. Patients with defects measuring greater than 10 cm in size
3. Patients with complex hernias requiring fascial mobilization for closure
4. Morbidly obese patients (BMI \>45)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Garth Jacobsen, MD

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Garth Jacobsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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University of California, San Diego Medical Center

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Lazar, MPH

Role: CONTACT

619-471-0447

Facility Contacts

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Sarah Lazar, MPH

Role: primary

619-471-0447

Other Identifiers

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081038, 150520

Identifier Type: -

Identifier Source: org_study_id

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