Minimally Invasive Surgery: Using Natural Orfices

NCT00530998 | Completed

• 1 other identifier: 071115, 140015
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

appendicitis; cholelithiasis; Gallstones

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (2)

1

Group #1 NOTES Appendectomy - Transvaginal approach

Procedure: Transvaginal Appendectomy

2

Group #2 NOTES Cholecystectomy - Transvaginal approach

Procedure: Transvaginal Cholecystectomy

Interventions

Transvaginal Appendectomy PROCEDURE

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

1

Transvaginal Cholecystectomy PROCEDURE

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

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant women (need to have negative icon in ER)
• Morbidly obese patients (BMI \>35)
• Patients who are taking immunosuppressive medications or are immunocompromised
• Patients with evidence of an abdominal abscess or mass
• Patients who present with a clinical diagnosis of sepsis or peritonitis
• Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
• Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
• Patients with diffuse peritonitis on clinical exam
• Patients on blood thinners or aspirin or abnormal blood coagulation tests
• Females between the ages of 18 and 75
• Diagnosis of gallstone disease which requires cholecystectomy
• ASA class 1
• Mentally competent to give informed consent
• Scheduled to undergo a transvaginal NOTES cholecystectomy
• Pregnant women

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Appendicitis; Cholelithiasis; Gallstones

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Biliary Tract Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Santiago Horgan, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

US (1)