Gallbladder retractor and Knot pusher with simultaneous coaxial traction : new laparoscopic instruments.

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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

Source(s) of monetary or material support:

MINSAP

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 Torres Peña, MD, PhD

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

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:

No

Research ethics committees:

Approved in 22 august 2000 by Ethic Committee of "Calixto Garcia" University Hospital

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

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".

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:

N/A

Inclusion criteria:

Patients older than 15 years-old, both gender, with diagnosis of symptomatic chronic cholelithiasis

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 , MD, PhD

Last Name:

Torres Peña

Affiliation:

National Center for Minimal Access Surgery

Postal Address:

Calle Párraga e/ San Mariano y Vista Alegre. 10 de Octubre.

City:

Habana City

Country:

Cuba

Zip Code:

Not entered

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 , MD, PhD

Last Name:

Torres Peña

Affiliation:

National Center for Minimal Access Surgery

Postal Address:

Calle Párraga e/ San Mariano y Vista Alegre. 10 de Octubre.

City:

Habana City

Country:

Cuba

Zip Code:

Not entered

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:

2008-07-28 20:00

Link to the spanish version:

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Gallbladder retractor and Knot pusher with simultaneous coaxial traction : new laparoscopic instruments.

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