Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder

Cholecystitis Clinical Trial

— NOTESchole  

Official title:

Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174069
• Other study ID #: LHS0701
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: October 2015

Study information

• Verified date: August 2019
• Source: The Oregon Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis

Intervention

Procedure:
• NOTES assisted laparoscopic cholecystectomy
Surgical removal of the gallbladder using endoscopic instruments.

Locations

Country	Name	City	State
United States	Legacy health System	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
The Oregon Clinic	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.	30 days
Secondary	Perception of surgical outcome	standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.	30 days post operatively