LOW DOse vs standard dose and administration TIme in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy: a randomised clinical trial.

Conditions

Symptomatic Cholelithiasis

Brief summary

Rate of identification of biliary structures prior to dissection of the hepatocystic triangle., Rate of identification of biliary structures after dissection of the hepatocystic triangle., Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent)., Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent)., Perceived usefulness of fluorescence cholangiography during surgery (1 = not useful, 2 = moderately useful, 3 = very useful)., Perceived disturbance from background liver fluorescence (liver-to-duct contrast): 0 = none, 1 = slight, 2 = significant.

Detailed description

Analysis on the primary variables described above, corresponding to the predictors of the technique: sex, BMI, type of biliary pathology, type of surgery, previous inflammatory changes, degree of surgical difficulty, previous instrumentation and imaging systems., Analysis of intraoperative and postoperative complication rates of the technique, categorised by treatment group., Analysis of the relationship between surgical time and length of hospital stay.

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Interventions

DRUGINDOCYANINE GREEN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of identification of biliary structures prior to dissection of the hepatocystic triangle., Rate of identification of biliary structures after dissection of the hepatocystic triangle., Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent)., Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent)., Perceived usefulness of fluorescence cholangiography during surgery (1 = not useful, 2 = moderately useful, 3 = very useful)., Perceived disturbance from background liver fluorescence (liver-to-duct contrast): 0 = none, 1 = slight, 2 = significant.	—

Measure

Time frame

Rate of identification of biliary structures prior to dissection of the hepatocystic triangle., Rate of identification of biliary structures after dissection of the hepatocystic triangle., Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent)., Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent)., Perceived usefulness of fluorescence cholangiography during surgery (1 = not useful, 2 = moderately useful, 3 = very useful)., Perceived disturbance from background liver fluorescence (liver-to-duct contrast): 0 = none, 1 = slight, 2 = significant.

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Secondary

Measure	Time frame
Analysis on the primary variables described above, corresponding to the predictors of the technique: sex, BMI, type of biliary pathology, type of surgery, previous inflammatory changes, degree of surgical difficulty, previous instrumentation and imaging systems., Analysis of intraoperative and postoperative complication rates of the technique, categorised by treatment group., Analysis of the relationship between surgical time and length of hospital stay.	—