Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS

Completed

• Conditions: Laparoscopic Cholecystectomy

• Registration Number: NCT04994171
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

Brief Summary

The main purpose of this study is to utilize operative grading scale to predict conversion to open,complication and reintervention and validate Nassar Scale.

Detailed Description

Laparoscopic cholecystectomy is the commonly performed procedure in our institute. Laparosopic cholecystectomy is high variable surgery ranging from simple routine operation to difficult surgery leading to increased morbidity and mortality. The majority of previous scores use a combination of pre-operative and operative data and were produced in studies that were limited by retrospective data, small sample sizes and lack of external validation.

Very few intraoperative difficulty grading scale was published and none are widely used in clinical practice. So operative grading scale will have advantages of assisting in intra-operative strategy and planning, allowing comparison across different research studies, facilitating risk adjustment for surgical outcomes and providing an aid in training surgeons and monitoring of training progression.

The main purpose of this study is to utilize operative grading scale to predict conversion to open,complication and reintervention.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-01-30
• Study Completion: 2021-06-01
• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Study First Posted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• All patients undergoing laparoscopic cholecystectomy

Exclusion Criteria

• CBD Stone
• Malignancy of Extrahepatic biliary tree
• Cholecystectomy as a part of other surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of Surgery	30 day
Laproscopic cholecystectomy Conversion to open with Nassar Grade	30 day	Laproscopic cholecystectomy converted to open with Nassar grade ie chance of conversion to open in higher Nassar grade(difficult laparoscopic cholecystectomy)
Introperative Complication with Nassar Grade	30 day	Complication like biliary spillage, stone spillage and bleeding with higher Nassar grade (difficult laparoscopic cholecystectomy)

Secondary Outcome Measures

Name	Time	Method
Total length of stay	30 day

Trial Locations

Locations (1)

Nirmal Prasad sah; 🇳🇵 Dharān Bāzār, Province 1, Nepal