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Gallbladder retractor and Knot pusher with simultaneous coaxial traction : new laparoscopic instruments.
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10 Abril 2013 - 10:18am
por Webmaster
16 Enero 2017 - 1:12pm
por lazara
Cambios a
Clinical sites
-
No
+
Not Applicable
Cambios a
Research ethics committees
-
Approved in 22 august 2000 by Ethic Committee of
"Calixto Garcia" University Hospital
+
"Calixto Garcia" University Hospital
, 22th august, 2000
Cambios a
First name
-
Rafael
Torres Peña, MD, PhD
+
Rafael
Cambios a
Last name
-
Not entered
+
Torres Peña
Cambios a
Health condition(s) code
-
+
Cholecystolithiasis
+
Cholelithiasis
+
Gallbladder Diseases
+
Bile Duct Diseases
+
Biliary Tract Diseases
+
Digestive System Diseases
Cambios a
Medical Specialty
-
+
2nd Degree Specialist in General Surgery
Cambios a
Affiliation
-
Not entered
+
National Center for Minimal Access Surgery
Cambios a
Postal address
-
Not entered
+
Párraga street #215, between San Mariano and Vista Alegre, La Víbora, 10 de Octubre
Cambios a
Intervention code
-
+
Cholecystectomy, Laparoscopic
+
Pneumoperitoneum, Artificial
+
Cholecystectomy
+
Laparoscopy
Cambios a
Intervention keyword
+
Gallbladder retractor,
+
Knot pusher with simultaneous coaxial traction
Cambios a
City
-
Not entered
+
Havana
Cambios a
Country
-
Not entered
+
Cuba
Cambios a
Zip Code
-
Not entered
+
10700
Cambios a
Maximum age
-
N/A
+
None
Cambios a
Inclusion criteria
-
Patients older than 15 years-old, both gender, with diagnosis of symptomatic chronic cholelithiasis
+
Patients older than 15 years-old, both gender, with diagnosis of symptomatic chronic cholelithiasis
tributary of surgical treatment.
Cambios a
First Name
-
Rafael
, MD, PhD
+
Rafael
Cambios a
Specialty
-
+
2nd Degree Specialist in General Surgery
Cambios a
Postal Address
-
Calle
Párraga
e/
San Mariano
y
Vista Alegre
.
10 de Octubre
.
+
Párraga
street #215, between
San Mariano
and
Vista Alegre
, La Víbora,
10 de Octubre
Cambios a
City
-
Habana City
+
Havana
Cambios a
Zip Code
-
Not entered
+
10700
Cambios a
First Name
-
Rafael
, MD, PhD
+
Rafael
Cambios a
Specialty
-
+
2nd Degree Specialist in General Surgery
Cambios a
Postal Address
-
Calle
Párraga
e/
San Mariano
y
Vista Alegre
.
10 de Octubre
.
+
Párraga
street #215, between
San Mariano
and
Vista Alegre
, La Víbora,
10 de Octubre
Cambios a
City
-
Habana City
+
Havana
Cambios a
Zip Code
-
Not entered
+
10700
Cambios a
Record Verification Date
-
2008-07-28 20:00
+
2017/01/16
Cambios a
Next update date
-
+
2018/01/16
Cambios a
Issuing authority of the secondary identifying numbers
-
+
National Center for Minimal Access Surgery
Cambios a
Secondary sponsor
-
No
+
Not Applicable
Cambios a
Source(s) of monetary or material support
-
MINSAP
+
Ministry of Public Health, CUBA
Revisión de 16 Enero 2017 - 1:12pm
Gallbladder retractor and Knot pusher with simultaneous coaxial traction : new laparoscopic instruments.
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Gallbladder retractor and Knot pusher with simultaneous coaxial traction: new laparoscopic instruments for minilaparoscopic cholecystectomy
Secondary indentifying numbers:
cncma001
Issuing authority of the secondary identifying numbers:
National Center for Minimal Access Surgery
Primary sponsor:
National Center for Minimal Access Surgery
Secondary sponsor:
Not Applicable
Source(s) of monetary or material support:
Ministry of Public Health, CUBA
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Rafael
Last name:
Torres Peña
Medical Specialty :
2nd Degree Specialist in General Surgery
Affiliation:
National Center for Minimal Access Surgery
Postal address:
Párraga street #215, between San Mariano and Vista Alegre, La Víbora, 10 de Octubre
City:
Havana
País:
Cuba
Zip Code:
10700
Telephone:
+53-76495333
Email address:
email@not.entered
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not Applicable
Research ethics committees:
"Calixto Garcia" University Hospital, 22th august, 2000
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
30/11/2000
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Symptomatic chronic cholelithiasis
Health condition(s) code:
Cholecystolithiasis
Cholelithiasis
Gallbladder Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Intervention(s):
All patients in both groups were operated on by the same experienced laparoscopic surgeon. A similar general anesthesia technique was followed in all cases. After pneumoperitoneum and initial laparoscopic exploration via umbilical trocar, and if not any exclusion criterion was present, the patients were randomized in two groups (A-experimental, B-control) by the sealed-envelope method based on a computer-generated list. In experimental group (n=50), the proposed new modified technique of mini-laparoscopic cholecystectomy was performed. In the control group (n=50), the conventional four-port laparoscopic cholecystectomy was performed. For mini-laparoscopic cholecystectomy experimental group two news laparoscopic instruments were designed: Gallbladder Retractor (GR) and Knot pusher with simultaneous coaxial traction (KP). The GR is a new 1,5-mm device for laparoscopy, designed to retract the gallbladder obviating the need to retract the fundus by the grasping forceps introduced through the subcostal 5-mm port in conventional laparoscopic cholecystectomy. The KP is another new device for laparoscopy, designed to place endo-loops on gallbladder wall for retraction with suture, obviating the need to retract the neck of gallbladder by 2nd grasping forceps introduced through the midclavicular subcostal 5-mm port in conventional laparoscopic cholecystectomy, without the risk of bile leakage associated to traction of sutures passed through the gallbladder wall in precedent "puppets techniques".
Intervention code:
Cholecystectomy, Laparoscopic
Pneumoperitoneum, Artificial
Cholecystectomy
Laparoscopy
Intervention keyword:
Gallbladder retractor, Knot pusher with simultaneous coaxial traction
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1-“Gallbladder’s fundus retraction”, timepoint: at the end of surgical procedure. Asses the efficacy of GR as retraction device for vesicular fundus. 2-“Placement of endo-loops sutures”, timepoint: at the end of surgical procedure. Asses the efficacy of KP to place endo-loops sutures to retract and expose the neck of gallbladder. 3-“Sliding of endo-loops sutures”, timepoint: at the end of surgical procedure. Asses the efficacy of KP, because it has influence on adequate surgical technique. 4- “Success on the technique of cholecystectomy proposed”, timepoint: at the end of surgical procedure. Asses the general efficacy of both instruments.
Key secondary outcomes:
- “Operative time”, timepoint: at the end of surgical procedure. - “CO2 consumption”, timepoint: at the end of surgical procedure. - “Adverse events related to the use of designed instruments”, timepoint: at the end of surgical procedure. - “Cosmetic results”, timepoint: at the follow-up, on 10-15 days before surgical procedure. - “Cost of surgical procedure”, timepoint: at the end of hospital stay.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
15 years
Maximum age:
None
Inclusion criteria:
Patients older than 15 years-old, both gender, with diagnosis of symptomatic chronic cholelithiasis tributary of surgical treatment.
Exclusion criteria:
PREOPERATIVE: -History of acute cholecystitis -History of cholangitis or bile duct calculus -History of pancreatitis -Hepatic cirrhosis associated -Morbid obesity -Acute cholecystitis -Clinical, chemical and/or echographic criteria for intraoperative cholangiographie -An added proposed surgical procedure DURING INITIAL LAPAROEXPLORATION: -Cancer of gallbladder -Severe inflammation of gallbladder -Extensive adhesions in abdominal right quadrant
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
Randomized controlled trial
Masking:
Single Blind
Control group:
Active
Study design:
Parallel
Phase:
3
Target sample size:
100 patients (50 patients per group)
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Rafael
Last Name:
Torres Peña
Specialty:
2nd Degree Specialist in General Surgery
Affiliation:
National Center for Minimal Access Surgery
Postal Address:
Párraga street #215, between San Mariano and Vista Alegre, La Víbora, 10 de Octubre
City:
Havana
País:
Cuba
Zip Code:
10700
Telephone:
(537) 649-5333 | FAX: (537) 649-0150
Email :
torres@cce.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Rafael
Last Name:
Torres Peña
Specialty:
2nd Degree Specialist in General Surgery
Affiliation:
National Center for Minimal Access Surgery
Postal Address:
Párraga street #215, between San Mariano and Vista Alegre, La Víbora, 10 de Octubre
City:
Havana
País:
Cuba
Zip Code:
10700
Telephone:
(537) 649-5333 | FAX: (537) 649-0150
Email :
torres@cce.sld.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000019
Date of Registration in Primary Registry:
2008-07-29
Record Verification Date:
2017/01/16
Next update date:
2018/01/16
Link to the spanish version:
Click here
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