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Laparoscopic Cholecystectomy With Retro-infundibular Approach

Laparoscopic Cholecystectomy With Retro-infundibular Approach Versus Standard Laparoscopic Cholecystectomy in Difficult Cases, Where Calot's Triangle is Unsafe to be Dissected

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02947256
Enrollment
125
Registered
2016-10-27
Start date
2013-07-31
Completion date
2016-01-31
Last updated
2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallstones

Brief summary

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.

Detailed description

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 : 1. De-shouldering of GB: by incising the serosal covering on either side of the infundibulum and lower part of the body. 2. This followed by dissection and separation of the lower third of GB body from its bed, using suction-irrigation probe or hook dissector. Dissection continued downward till the GB pedicle (duct and artery). 3. Mass ligation of cystic artery and duct, using intracorporeal note by vicryl number 1 suture. 4. Then the surgeon cut above the ligature using diathermy on scissor or ultrasound sealing device. During this step the cut end of the GB was grasped by forceps trying to prevent spillage of its content, if happened, stones were collected in a bag and extracted. 5. Then GB was dissected from its bed as usual and extracted in a bag. In cases where the GB was hugely distended, it was aspirated firstly to facilitate its grasping. Also in cases of Mirizzi syndrome the GB was opened direct on the stone to remove it, to facilitate grasping of GB then we continued as described above

Interventions

which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery

PROCEDURERI approach

which included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patient with gallstones * score difficulty according to Gupta et al 2013 \> 6 * patient fit for laparoscopic surgery

Exclusion criteria

* score difficulty according to Gupta et al 2013 \> 6 * patient unfit for laparoscopic surgery * refusal to share in the study

Design outcomes

Primary

MeasureTime frameDescription
biliary injury2 weeksthe incidence of biliary injury
conversion to open24 hoursthe incidence of conversion to open

Secondary

MeasureTime frameDescription
operative time24 hourstime from skin opening to skin closure
hospital stay6 weekstime of hospital stay
mortality6 weeksincidence of operative related mortality

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026