Minimally Invasive Surgery: Using Natural Orfices (NOTES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00530998
First received: September 17, 2007
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following:

  • Subjects will complete a 7 day pain/temperature log after surgery
  • Subjects will complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months after surgery
  • Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction

Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.


Condition Intervention
Appendicitis
Cholelithiasis
Gallstones
Procedure: Transvaginal Appendectomy
Procedure: Transvaginal Cholecystectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate pain associated with the transvaginal approach (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2007
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Group #1 NOTES Appendectomy - Transvaginal approach
Procedure: Transvaginal Appendectomy
The appendix will be removed via an incision in the vagina.
2
Group #2 NOTES Cholecystectomy - Transvaginal approach
Procedure: Transvaginal Cholecystectomy
The gallbladder will be removed via an incision in the vagina.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Group #1: NOTES Appendectomy - Transvaginal approach:

Subjects will be female between the ages of 18-75 who present to the emergency room and are subsequently diagnosed with acute appendicitis. Following diagnosis, investigators will determine if the procedure can be completed via the transvaginal approach. If the patient satisfies the listed criteria then researchers will present study information and offer participation.

Group # 2: NOTES Cholecystectomy - Transvaginal approach:

Female subjects, between the ages of 18-75 who present in the UCSD surgery clinic for elective cholecystectomy will be offered participation in this study.

Criteria

Inclusion criteria for transvaginal appendectomy:

  1. Females between the ages of 18-75
  2. Clinical diagnosis of appendicitis
  3. Emergency room evaluation within 36 hours of the onset of pain
  4. ASA Classification 1
  5. Mentally competent to give informed consent
  6. Scheduled to undergo a transvaginal NOTES appendectomy.

Exclusion criteria for transvaginal appendectomy:

  1. Pregnant women (need to have negative icon in ER)
  2. Morbidly obese patients (BMI >35)
  3. Patients who are taking immunosuppressive medications or are immunocompromised
  4. Patients with evidence of an abdominal abscess or mass
  5. Patients who present with a clinical diagnosis of sepsis or peritonitis
  6. Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
  7. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
  8. Patients with diffuse peritonitis on clinical exam
  9. Patients on blood thinners or aspirin or abnormal blood coagulation tests

Inclusion criteria for transvaginal cholecystectomy:

  1. Females between the ages of 18 and 75
  2. Diagnosis of gallstone disease which requires cholecystectomy
  3. ASA class 1
  4. Mentally competent to give informed consent
  5. Scheduled to undergo a transvaginal NOTES cholecystectomy

Exclusion criteria for transvaginal cholecystectomy:

  1. Pregnant women
  2. Morbidly obese patients (BMI > 35)
  3. Patients who are taking immunosuppressive medications and/or immunocompromised
  4. Patients with severe medical comorbidities will be excluded.
  5. Patients with a presumed gallbladder polyps, mass or tumor
  6. Patients with a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
  7. Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
  8. Patients with known common bile duct stones
  9. 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: NCT00530998

Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Principal Investigator: Santiago Horgan, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Santiago Horgan, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00530998     History of Changes
Other Study ID Numbers: 071115, 140015
Study First Received: September 17, 2007
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
appendicitis
cholelithiasis
Gallstones

Additional relevant MeSH terms:
Appendicitis
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi
Cecal Diseases
Digestive System Diseases
Gallbladder Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intestinal Diseases
Intraabdominal Infections
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2015