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

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.

Study Overview

• Status: Completed
• Conditions: Gallstones
• Intervention / Treatment: Procedure: standard laparoscopic cholecystectomy; Procedure: RI approach

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

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Minia, Egypt, 61511
    • Faculty of medicine
  • Minia, Egypt, 61511
    • Minia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: standard laparoscopic cholecystectomy; 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; which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery; Other Names: SLC
EXPERIMENTAL: RI approach; 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 separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conversion to open	the incidence of conversion to open	24 hours
biliary injury	the incidence of biliary injury	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	time from skin opening to skin closure	24 hours
hospital stay	time of hospital stay	6 weeks
mortality	incidence of operative related mortality	6 weeks

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Alaa M Sewefy, MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: October 22, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (ESTIMATE): October 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 29, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Gallstones
• Other Study ID Numbers: fac.med.011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO