Minimally Invasive Surgery: Using Natural Orfices

NCT ID: NCT00530998

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2019-09-30

Brief 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.

Conditions

Appendicitis; Cholelithiasis; Gallstones

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Group #1 NOTES Appendectomy - Transvaginal approach

Transvaginal Appendectomy

Intervention Type: PROCEDURE

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

2

Group #2 NOTES Cholecystectomy - Transvaginal approach

Transvaginal Cholecystectomy

Intervention Type: PROCEDURE

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

Interventions

Transvaginal Appendectomy

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

Intervention Type: PROCEDURE

Transvaginal Cholecystectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Santiago Horgan

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Santiago Horgan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

071115, 140015

Identifier Type: -

Identifier Source: org_study_id