Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder (NOTESchole)

Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy

Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be feasible and have comparable complication rates as standard lap cholecystectomy. Patient benefits will include less pain and scaring.

Study Overview

• Status: Completed
• Conditions: Cholecystitis
• Intervention / Treatment: Procedure: NOTES assisted laparoscopic cholecystectomy

Detailed Description

In this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5 cm umbilical incision. A flexible endoscope will be inserted through the mouth and into the stomach. Using commercially available endoscopes, endoscopic instruments and accessories, a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. Two to three small laparoscopic trocars will be placed for laparoscopic instrument insertion to manipulate, retract and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. Once dissected free, the gall bladder will be removed through the stomach and out of the mouth. Commercially available endoscopic clips, sutures and/or tissue anchors will be used to close the gastrotomy; additionally, the gastrotomy will be tested for leaks and laparoscopically oversewn with suture as needed.

Patients will be discharged per the standard of practice for a laparoscopic cholecystectomy. During the hospital stay severity of pain and use of pain medications will be recorded. Length of time spent in the recovery room and in the hospital will also be collected. Patients will return and be evaluated by their surgeon two weeks following their procedure. At this visit, any complications will be noted in the patient's medical record. Additionally at this visit and at the preoperative visit, patients will complete a standardized Quality of Life (QOL) assessment (i.e., SF-36) and perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ability to undergo general anesthesia
2. Age > 18 years of age and < 80 years of age
3. Ability to give informed consent

Exclusion Criteria:

1. Acute cholecystitis
2. Body Mass Index (BMI) > 40
3. Contraindicated for esophagogastroduodenoscopy (EGD)
4. Gallstones > 2.5cm in diameter
5. Gall bladder more than 15cm in length on U/S
6. Presence of common duct stones
7. Presence of esophageal stricture
8. Altered gastric anatomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NOTES cholecystectomy	Procedure: NOTES assisted laparoscopic cholecystectomy; Surgical removal of the gallbladder using endoscopic instruments.; Other Names: NOTES Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of surgical outcome	standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.	30 days post operatively

Collaborators and Investigators

• Sponsor: The Oregon Clinic
• Collaborators: Northwestern University
• Investigators: Principal Investigator: Christy M Dunst, MD, The Oregon Clinic; Study Director: Angi B Gill, RN, The Oregon Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2007
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: cholecystectomy; endoscopic; NOTES
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis
• Other Study ID Numbers: LHS0701