Natural Orifice Translumenal Endoscopic Surgery (NOTES):... | NCT01398215

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

NCT01398215

Sponsor

University of California, San Diego

Status

Unknown status

Last Update Posted

May 1, 2018Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Umbilical Hernia
Ventral Hernia

Interventions

transvaginal NOTES ventral hernia repair

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2019Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Jul 14, 2011

First Submission Date that Met QC Criteria

Jul 19, 2011

First Posted Date

Jul 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2018

Last Update Posted Date

May 1, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Garth Jacobsen, MD, Assistant Professor of Surgery, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
transvaginal NOTES			Procedure: transvaginal NOTES ventral hernia repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transvaginal NOTES ventral hernia repair	Procedure	ventral hernia repair via the transvaginal approach	transvaginal NOTES

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).		1 Year
To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).		1 Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

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

Exclusion:

Pregnant women
Patients with defects measuring greater than 10 cm in size
Patients with complex hernias requiring fascial mobilization for closure
Morbidly obese patients (BMI >45)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Lazar, MPH	Contact	619-471-0447		misresearch@ucsd.edu

Overall Officials

Name	Affiliation	Role
Garth Jacobsen, M.D.	UCSD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Diego Medical Center	Recruiting	San Diego	California	92103	United States

Condition Browse Module

MeSH Terms

ID	Term
D006554	Hernia, Umbilical
D006555	Hernia, Ventral

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D046449	Hernia, Abdominal
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided