CClinicalTrials.gg
Sign In
CompletedNCT00530998NOTESUpdated Mar 10, 2020

Minimally Invasive Surgery: Using Natural Orfices

An observational study in Appendicitis, Cholelithiasis and Gallstones, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by University of California, San Diego · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Appendicitis
  • Cholelithiasis
  • Gallstones

Keywords

  • appendicitis
  • cholelithiasis
  • Gallstones
03

In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's enrollment of 120 is below the median of 200 across 150 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 69 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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

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.

Inclusion criteria

  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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    Group #1 NOTES Appendectomy - Transvaginal approach

    Procedure: Transvaginal Appendectomy

  • 2

    Group #2 NOTES Cholecystectomy - Transvaginal approach

    Procedure: Transvaginal Cholecystectomy

Interventions

  • ProcedureTransvaginal Appendectomy

    The appendix will be removed via an incision in the vagina.

  • ProcedureTransvaginal Cholecystectomy

    The gallbladder will be removed via an incision in the vagina.

06

What researchers measure

Primary outcomes

  1. To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).

    Time frame: 1 year

Secondary outcomes

  1. To evaluate pain associated with the transvaginal approach (through data collection).

    Time frame: 1 year

07

Study locations

1 site
  • University of California, San Diego
    San Diego, California 92103, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00530998
Lead sponsor
University of California, San Diego
Responsible party
Santiago Horgan (Professor of Surgery, University of California, San Diego) — Principal investigator
First posted
Sep 18, 2007
Start date
Sep 2007
Primary completion
Sep 2019
Completion
Sep 2019
Last update
Mar 10, 2020

Study contacts

Santiago Horgan, MD
principal investigator · University of California, San Diego

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Appendicitis→

Other studies from this sponsor

University of California, San Diego

Start the discussion