Minimally Invasive Surgery: Using Natural Orifice Translumenal Endoscopic Surgery (NOTES)

NCT00531219 | Unknown

• 1 other identifier: 071114, 140016
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study of pain and outcomes from patients undergoing transgastric NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric 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 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

Keywords

appendicitis; cholelithiasis; gallstones

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (2)

1

Group #1 NOTES Appendectomy - Transgastric approach

Procedure: Transgastric Appendectomy

2

Group #2 NOTES Cholecystectomy - Transgastric approach

Procedure: Transgastric Cholecystectomy

Interventions

Transgastric Appendectomy PROCEDURE

The appendix will be removed through an incision in the stomach and pulled out through the mouth

1

Transgastric Cholecystectomy PROCEDURE

The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There will be 2 groups in this study: Of special note, the inclusion criteria clearly states subjects must be seen within 36 hours of the onset of pain and have an ASA Classification of I. This is intended to avoid obtaining informed consent from a subject who is in severe pain and incapable of making an informed decision, as well as avoid coercion. An ASA Classification of I defines a healthy normal individual. 1. Group 1 will be transgastric laparoscopic assisted appendectomy 2. Group 2 will be transgastric laparoscopic assisted cholecystectomy

You may qualify if:

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

You may not qualify if:

• Pregnant women
• Morbidly obese patients (Body mass index \> 35)
• Patients who are taking immunosuppressive medications or are immunocompromised
• Patients who are on Proton Pump Inhibitors (PPI)
• Patients with evidence of an abdominal abscess or mass on CT scan
• Patients who present with a clinical diagnosis of sepsis
• Patients who have a history of open abdominal surgery
• Patients with diffuse peritonitis
• Patients on blood thinners or aspirin
• Males and Females between the ages of 18 -75
• Diagnosis of gallstone disease that require cholecystectomy
• ASA classification I
• Mentally competent to give informed consent.
• Scheduled to undergo a transgastric 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

RECRUITING

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

Central Study Contacts

Sarah Lazar, MPH

CONTACT

619-471-0447; misresearch@ucsd.edu

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: February 1, 2008
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2020
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (1)