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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000019
• Date of registration: 29/07/2008
• Primary sponsor: National Center for Minimal Access Surgery
• Public title: Gallbladder retractor and Knot pusher with simultaneous coaxial traction : new laparoscopic instruments.
• Scientific title: Gallbladder retractor and Knot pusher with simultaneous coaxial traction: new laparoscopic instruments for minilaparoscopic cholecystectomy
• Date of first enrolment: 30/11/2000
• Target sample size: 100 patients (50 patients per group)
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000019-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Single Blind Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Rafael , MD, PhD Torres Peña
• Affiliation: National Center for Minimal Access Surgery

• Name: Rafael , MD, PhD Torres Peña
• Affiliation: National Center for Minimal Access Surgery

Key inclusion & exclusion criteria

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

Age minimum: 15 years
Age maximum: N/A
Gender: Both

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".

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.

Secondary Outcome(s)

- “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.

Secondary ID(s)

cncma001

Source(s) of Monetary Support

MINSAP