Laparoscopic Cholecystectomy With Retro-infundibular Approach

NCT ID: NCT02947256

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-01-31

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

Conditions

Gallstones

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

standard laparoscopic cholecystectomy

Intervention Type: PROCEDURE

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

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:

Group Type: EXPERIMENTAL

RI approach

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

SLC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mstafa Hassan Sewefy

MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa M Sewefy, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.

Locations

Faculty of medicine

Minya, , Egypt

Minia University Hospital

Minya, , Egypt

Countries

Egypt

Other Identifiers

fac.med.011

Identifier Type: -

Identifier Source: org_study_id