ClinicalTrials.gg
Status unknownNCT01398215NOTESUpdated May 1, 2018

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

An observational study in Umbilical Hernia and Ventral Hernia, sponsored by University of California, San Diego. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by University of California, San Diego · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Hernia, Umbilical with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Hernia, Umbilical · United States.

Started
2009
with 1 other
Observational
Only one
of the 12
Registered
6th of 12
by date

Among the 12 studies in Hernia, Umbilical with a site in United States, this one is one of 2 that started in 2009, is the only observational one, and was the 6th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phase9 · 2 open
Observationalthis study1 · 0 open
Phase 21 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2006; this study’s year is marked. 2 started in 2009.

What they test

Size and results

Median enrollment 52 across the 11 interventional studies, 50 across the 1 observational. Of the 9 that completed or were terminated, 4 (44%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 12 studies in Hernia, Umbilical with a site in United States, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Umbilical Hernia
  • Ventral Hernia

Keywords

  • umbilical hernia
  • ventral hernia
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who come to the UC San Diego Surgical Specialties clinic and have chosen to undergo a ventral hernia repair will be evaluated for participation in this tria

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 ( >45)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • transvaginal NOTES

    Procedure: transvaginal NOTES ventral hernia repair

Interventions

  • Proceduretransvaginal NOTES ventral hernia repair

    ventral hernia repair via the transvaginal approach

06

What researchers measure

Primary outcomes

  1. To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).

    Time frame: 1 Year

  2. To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).

    Time frame: 1 Year

07

Study locations

1 of 1 sites recruiting
  • University of California, San Diego Medical Center
    San Diego, California 92103, United States
    Recruiting
    • Sarah Lazar, MPH · Contactmisresearch@ucsd.edu · 619-471-0447
    • Garth Jacobsen, M.D. · Principal investigator
    • Santiago Horgan, M.D. · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2009, a primary completion of Jan 2019 and a completion of Jan 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2011
First posted
Jul 20, 2011
Start
Jan 2009
Primary completionEst.
Jan 2019
CompletionEst.
Jan 2019
Last update
May 1, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01398215
Responsible party
Garth Jacobsen, MD (Assistant Professor of Surgery, University of California, San Diego) — Principal investigator
First posted
Jul 20, 2011
Start date
Jan 2009
Primary completion
Jan 2019 (estimated)
Completion
Jan 2019 (estimated)
Last update
May 1, 2018

Study contacts

Sarah Lazar, MPH
Contact
misresearch@ucsd.edu
619-471-0447
Garth Jacobsen, M.D.
principal investigator · UCSD

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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