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CompletedNCT02947256Updated Nov 1, 2016

Laparoscopic Cholecystectomy With Retro-infundibular Approach

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

Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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
02

Conditions studied

  • Gallstones

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03

In context

Gallstones

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.

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Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • score difficulty according to Gupta et al 2013 > 6
  • patient unfit for laparoscopic surgery
  • refusal to share in the study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Procedurestandard 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

    Also known as: SLC

  • 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.

06

What researchers measure

Primary outcomes

  1. conversion to open

    the incidence of conversion to open

    Time frame: 24 hours

  2. biliary injury

    the incidence of biliary injury

    Time frame: 2 weeks

Secondary outcomes

  1. operative time

    time from skin opening to skin closure

    Time frame: 24 hours

  2. hospital stay

    time of hospital stay

    Time frame: 6 weeks

  3. mortality

    incidence of operative related mortality

    Time frame: 6 weeks

07

Study locations

2 sites
  • Faculty of medicine
    Minya, 61511, Egypt
  • Minia University Hospital
    Minya, 61511, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02947256
Lead sponsor
Minia University
Responsible party
Alaa Mstafa Hassan Sewefy (MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt, Minia University) — Principal investigator
First posted
Oct 27, 2016
Start date
Jul 2013
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Nov 1, 2016

Study contacts

Alaa M Sewefy, MD
principal investigator · Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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