Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01558414
Status:
COMPLETED
Last Update Posted:
2013-03-12
First Post:
2012-03-17
Brief Title:
Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy
Sponsor:
Jose F Noguera
Organization:
Hospital Son Llatzer
Study Overview
Official Title:
Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective randomized pilot clinical trial with 3 arms and one year follow up The study will include 60 patients with a 111 ratio 20 patients per group In 40 patients a transumbilical single site incision will be performed with two different manners single-port device SILS TM Single Incision Laparoscopic Surgery and flexible endoscope and accessory trocars in a single incision FSIS-Flexible Single Incision Surgery The third group is the control one a conventional laparoscopic approach
The trial is designed as a pilot study to assess as main objective if these two endoscopic approaches have the same security and effectiveness in cholecystectomy
Hypothesis
Transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy
Objectives
Main objective
Assess whether both approaches are equally safe in its application to endoscopic cholecystectomy
Secondary objectives
Investigate the differences in the rate of conversion to open surgery between different surgical approaches
Investigate the differences in the rate of wound infection between the different surgical approaches
Investigate the differences in the rate of postoperative incisional hernias between different surgical approaches
Investigate whether there are differences in the rate of overall complications all-cause mortality and the cost between different surgical approaches
The trial is designed as a pilot study to assess as main objective if these two endoscopic approaches have the same security and effectiveness in cholecystectomy
Hypothesis
Transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy
Objectives
Main objective
Assess whether both approaches are equally safe in its application to endoscopic cholecystectomy
Secondary objectives
Investigate the differences in the rate of conversion to open surgery between different surgical approaches
Investigate the differences in the rate of wound infection between the different surgical approaches
Investigate the differences in the rate of postoperative incisional hernias between different surgical approaches
Investigate whether there are differences in the rate of overall complications all-cause mortality and the cost between different surgical approaches
Detailed Description:
Inclusion criteria
Patients affected with symptomatic cholelithiasis with elective surgical indication not urgent aged between 18 and 65
Signing of informed consent for cholecystectomy and specific consent for the trial
Anesthetic risk ASA I-II
Exclusion criteria
Presence of acute cholecystitis and or suspicion of occupation of the main bile duct
ASA III and higher
Patients affected with symptomatic cholelithiasis with elective surgical indication not urgent aged between 18 and 65
Signing of informed consent for cholecystectomy and specific consent for the trial
Anesthetic risk ASA I-II
Exclusion criteria
Presence of acute cholecystitis and or suspicion of occupation of the main bile duct
ASA III and higher
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None