Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder (NOTESchole)
Recruitment status was: Recruiting
|Cholecystitis||Procedure: NOTES assisted laparoscopic cholecystectomy||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy|
- Postoperative pain [ Time Frame: 30 days ]perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.
- Quality of Life [ Time Frame: 30 days post operatively ]standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Experimental: NOTES cholecystectomy||
Procedure: NOTES assisted laparoscopic cholecystectomy
Surgical removal of the gallbladder using endoscopic instruments.
Other Name: NOTES Cholecystectomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174069
|Contact: Lee L Swanstrom, MDemail@example.com|
|United States, Oregon|
|Legacy health System||Recruiting|
|Portland, Oregon, United States, 97210|
|Principal Investigator: Lee L Swanstrom, MD|
|Principal Investigator:||Lee L Swanstrom, MD||Legacy Health System|
|Study Director:||Angi B Gill, RN||Oregon Clinic|