Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder

NCT ID: NCT01174069

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2015-10-31

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.

Conditions

Cholecystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NOTES cholecystectomy

Group Type: EXPERIMENTAL

NOTES assisted laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Surgical removal of the gallbladder using endoscopic instruments.

Interventions

NOTES assisted laparoscopic cholecystectomy

Surgical removal of the gallbladder using endoscopic instruments.

Intervention Type: PROCEDURE

Other Intervention Names

NOTES Cholecystectomy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

The Oregon Clinic

OTHER

Sponsor Role: lead

Responsible Party

Lee Swanstrom

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christy M Dunst, MD

Role: PRINCIPAL_INVESTIGATOR

The Oregon Clinic

Angi B Gill, RN

Role: STUDY_DIRECTOR

The Oregon Clinic

Locations

Legacy health System

Portland, Oregon, United States

Countries

United States

Other Identifiers

LHS0701

Identifier Type: -

Identifier Source: org_study_id