Laparoscopic cholecystectomy. MedDRA version: 20.0 Level: PT Classification code 10008611 Term: Cholecystectomy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
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Sponsors
Instituto de Investigación Biomédica de Salamanca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age over 18 years. • Autonomy, self-sufficiency and independence. • Scheduled CL indication: - Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis. - Gallbladder polyps with indication for laparoscopic surgery. - Vesicular adenomyomatosis with indication for laparoscopic surgery. • Indication of early LC (=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Age less than 18 years. • Disability. • Pregnancy or lactation. • Chronic kidney disease (Stage > IIIb). • Previous adverse reactions or allergies to VI. • Previous adverse reactions or allergies to VI excipients. • Adverse reactions or confirmed allergies to iodinated contrast agents. • Functional thyroid pathology (hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma). • Urgent non-deferrable/emergent gallbladder surgery. • Initial surgery by laparotomy. • Previous suspicion of gallbladder carcinoma. • Inability to understand the information needed to participate in the study. • Rejection of inclusion within the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 334 / 5.000 Resultados de traducción The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.;Secondary Objective: 1.020 / 5.000 Resultados de traducción 1. To analyze the influence of the body mass index on the results of the CF during the LC. 2. To analyze the influence of the type of biliary pathology secondary to surgery on the results of FC during LC. 3. To analyze the influence of the type of surgery (elective/early) on the results of FC during LC. 4. To analyze the influence of previous inflammatory changes on the results of FC during LC. 5. To analyze the influence of prior gallbladder or bile duct instrumentation on the results of FC during LC. 6. To analyze the influence of the different laparoscopic imaging systems on the results of FC during LC. 7. To analyze the rate of intraoperative complications related to FC during LC. 8. To analyze the rate of postoperative complications related to FC during LC.;Primary end point(s): • Identification of biliary structures prior to dissection of the hepatocystic triangle. • Identification of biliary structures after dissection of the hepatocystic triangle.;Timepoint(s) of evaluation of this end point: At the time of the surgical procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. • Degree of identification of biliary structures after dissection of the hepatocystic triangle. • Extent to which fluorescence cholangiography was perceived as useful for surgery • Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbingPlease enter information in English and add any other language that is applicable;Timepoint(s) of evaluation of this end point: At the time of the surgical procedure | — |
Countries
Spain
Contacts
Public ContactÁrea de Ensayos Clínicos
UICEC IBSAL
Outcome results
None listed