A Phase 2 interventional study of standard laparoscopic cholecystectomy and RI approach in Gallstones, sponsored by Minia University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-01.
Sponsored by Minia University · Phase 2, Interventional, and Treatment
Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred chole-cystohepatic (Calot's) triangle.
This study is a prospective cohort study, conducted in Minia university hospital and Minia insurance hospital in the period from July 2013 to January 2016, where 597 patients with gallstones were admitted for laparoscopic cholecystectomy and were done by the same surgeon. Based on the preoperative scoring system to predict the degree of difficulty in laparoscopic cholecystectomy, patients that had the score > 6 and were fit for laparoscopic surgery were included in the study. Only 125 met these criteria and agreed to share in the study and gave their informed consent. 60 patients were operated by SLC (Group 1).This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery. While, 65 patients were operated by laparoscopic cholecystectomy using RI approach (Group 2). This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.
Operative procedure of by RI approach:
The site of trocars was the same as for the standard cholecystectomy. After dissection of adhesion masking the GB, if present, to reach the Hartmann pouch, at this point Calot's triangle usually was scarred and frozen, the surgeon never tried to dissect it and instead the surgeon continued as follow :
354 studies on the registry are indexed under Gallstones; 47 are open to participants now.
This study's enrollment of 125 is above the median of 94 across 237 interventional studies indexed under Gallstones.
Browse Gallstones studies →Minia University is the lead sponsor of 369 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery.
Procedure: standard laparoscopic cholecystectomy
Retroinfundibular laparoscopic cholecystectomy: This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both. Operative procedure of by RI approach:
Procedure: RI approach
which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery
Also known as: SLC
which included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.
conversion to open
the incidence of conversion to open
Time frame: 24 hours
biliary injury
the incidence of biliary injury
Time frame: 2 weeks
operative time
time from skin opening to skin closure
Time frame: 24 hours
hospital stay
time of hospital stay
Time frame: 6 weeks
mortality
incidence of operative related mortality
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.