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

Primary Purpose

Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOTES assisted laparoscopic cholecystectomy
Sponsored by
The Oregon Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis focused on measuring NOTES, cholecystectomy, endoscopic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Legacy health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NOTES cholecystectomy

Arm Description

Outcomes

Primary Outcome Measures

Postoperative pain
perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.

Secondary Outcome Measures

Perception of surgical outcome
standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.

Full Information

First Posted
July 30, 2010
Last Updated
August 29, 2019
Sponsor
The Oregon Clinic
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01174069
Brief Title
Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder
Acronym
NOTESchole
Official Title
Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2007 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Oregon Clinic
Collaborators
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
Keywords
NOTES, cholecystectomy, endoscopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NOTES cholecystectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
NOTES assisted laparoscopic cholecystectomy
Other Intervention Name(s)
NOTES Cholecystectomy
Intervention Description
Surgical removal of the gallbladder using endoscopic instruments.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Perception of surgical outcome
Description
standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.
Time Frame
30 days post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to undergo general anesthesia Age > 18 years of age and < 80 years of age Ability to give informed consent Exclusion Criteria: Acute cholecystitis Body Mass Index (BMI) > 40 Contraindicated for esophagogastroduodenoscopy (EGD) Gallstones > 2.5cm in diameter Gall bladder more than 15cm in length on U/S Presence of common duct stones Presence of esophageal stricture Altered gastric anatomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy M Dunst, MD
Organizational Affiliation
The Oregon Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angi B Gill, RN
Organizational Affiliation
The Oregon Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Legacy health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder

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