NOTES-Assisted Laparoscopic Cholecystectomy Surgery (TAS-NOTES)
|ClinicalTrials.gov Identifier: NCT00848146|
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : July 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholecystectomy, Laparoscopic Endoscopy||Procedure: Endoscopically assisted Laparoscopic Cholecystectomy Surgery||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natural Orifice Translumenal Endoscopic Surgery (NOTES)-Assisted Laparoscopic Cholecystectomy Surgery|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: NOTES-Assisted Lap Chole
These patients will undergo an experimental surgical procedure that uses a combination of laparoscopic instruments (i.e., inserted through the skin into the abdominal cavity) and flexible endoscopic instruments (i.e., inserted through the mouth).
Procedure: Endoscopically assisted Laparoscopic Cholecystectomy Surgery
Using endoscopic instruments a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. At least one laparoscopic trocars will be placed through the abdominal wall for laparoscopic instrument insertion to manipulate 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. The gallbladder will be removed through the stomach and out of the mouth. Endoscopic clips, sutures or tissue anchors (TAS)will be used to close the gastrotomy.
- post operative pain [ Time Frame: two weeks ]
- quality of life [ Time Frame: two weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848146
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Eric S Hungness, M.D.||Northwestern University|