NOTES-Assisted Laparoscopic Cholecystectomy Surgery
Completed · Not applicable
Conditions studied: Cholecystectomy, Laparoscopic, Endoscopy
In brief
Refinements in laparoscopic surgery, coupled with advancements in therapeutic flexible endoscopy, have set the stage for surgery to move to even less invasive techniques to treat conditions in the GI tract and peritoneal cavity. Natural orifice translumenal endoscopic surgery (NOTES) offers a means of reducing and ultimately eliminating the need for abdominal incisions to gain access to the peritoneal cavity. In NOTES, a flexible endoscope and accessory instruments are inserted through a natural body orifice and passed through the wall of an organ to reach the abdominal cavity. By reducing or eliminating the need for abdominal incisions, NOTES may provide a least invasive surgical option that can reduce pain, recovery time, complications, and systemic inflammatory response when compared to a laparoscopic surgical approach. In this study, we propose to use the NOTES technique to eliminate the need for a 1.5-2.5 cm umbilical incision. Hypothesis 1: We hypothesize that a combined endoscopic and laparoscopic approach will be able to eliminate a 1.5 to 2.5 cm infraumbilical incision when performing a laparoscopic cholecystectomy. Hypothesis 2: Closure of the gastrotomy will be facilitated with the Ethicon TAS system.
Key facts
- Study ID
- NCT00848146
- Run by
- Northwestern University
- People needed
- 4
- Starts
- 2009-02-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2012-07-04
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and < 85 yrs. of age
- Ability to give informed consent
You may not qualify if…
- Acute cholecystitis
- BMI > 40
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Presence of common duct stones
- Presence of esophageal stricture
- Altered gastric anatomy
- Gallstone greater than 1.5cm diameter seen on pre-op ultrasound
- Pregnancy
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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