Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Ventral Hernia Repair

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01398215
First received: July 14, 2011
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

This study is looking at the safety and effectiveness of Trans-vaginal ventral or umbilical hernia repair versus the standard laparoscopic repair that is currently being done.


Condition Intervention
Umbilical Hernia
Ventral Hernia
Procedure: transvaginal NOTES ventral hernia repair

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Ventral Hernia Repair

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Safety and Efficacy as measured by pain and temperature log post-op [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Patient will be given a 7-day pain and temperature log on which they will record pain/temperature for 7 days post-op.

  • Safety and efficacy as measured by # of adverse events. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: January 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transvaginal NOTES Procedure: transvaginal NOTES ventral hernia repair
ventral hernia repair via the transvaginal approach

Detailed Description:

A pilot study looking at a novel surgical approach for a commonly performed laparoscopic surgery; umbilical herniorrhaphy or incisional herniorrhaphy (here in to be defined as ventral herniorrhaphy).

The purpose of the study is to determine the safety and efficacy of the transvaginal approach to an operation, in which the surgeon creates an opening in the vagina and inserts an endoscope into the peritoneal cavity. All instruments and devices in the study are FDA approved for the specific tasks for which they are utilized.

There will be one group in this pilot, with 10 subjects in the group.

Subjects will be female between the ages of 18-64 who present to the general surgery clinic and are subsequently diagnosed with a ventral hernia. Following diagnosis, investigators will be contacted by the surgical consult team to determine if a patient meets criteria for the study. If the patient satisfies the listed criteria then researchers will present study information and offer participation.

Inclusion criteria for NOTES Ventral Herniorrhaphy

  1. Females between the ages of 18-64
  2. Umbilical or Incisional hernia greater than 2 cm in size

Exclusion criteria for NOTES Ventral Herniorrhaphy

  1. Pregnant women (need to have negative icon in ER)
  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)
  5. Patients who are taking immunosuppressive medications or are immunocompromised
  6. Patients with evidence of an abdominal abscess or mass
  7. Patients who present with a clinical diagnosis of sepsis or peritonitis
  8. Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery or with prior pelvic surgery will be included.
  9. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
  10. Previous trauma to the perineal area
  11. Patients on blood thinners or aspirin or abnormal blood coagulation tests
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria for NOTES Ventral Herniorrhaphy

  1. Females between the ages of 18-64
  2. Umbilical or Incisional hernia greater than 2 cm in size

Exclusion criteria for NOTES Ventral Herniorrhaphy

  1. Pregnant women (need to have negative icon in ER)
  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)
  5. Patients who are taking immunosuppressive medications or are immunocompromised
  6. Patients with evidence of an abdominal abscess or mass
  7. Patients who present with a clinical diagnosis of sepsis or peritonitis
  8. Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery or with prior pelvic surgery will be included.
  9. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
  10. Previous trauma to the perineal area
  11. Patients on blood thinners or aspirin or abnormal blood coagulation tests
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398215

Locations
United States, California
University of California, San Diego Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Garth Jacobsen, M.D. UCSD
  More Information

No publications provided

Responsible Party: Garth Jacobsen, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01398215     History of Changes
Other Study ID Numbers: 081038
Study First Received: July 14, 2011
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
umbilical hernia
ventral hernia

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Hernia, Ventral
Hernia, Abdominal
Infant, Newborn, Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014