Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994171
• Other study ID #: 1758/020
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2021
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 1, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients undergoing laparoscopic cholecystectomy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Locations

Country	Name	City	State
Nepal	Nirmal Prasad sah	Dharan Bazar	Province 1

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

References & Publications (3)

Ahmed N, Hassan MU, Tahira M, Samad A, Rana HN. Intra-Operative Predictors of difficult cholecystectomy and Conversion to Open Cholecystectomy - A New Scoring System. Pak J Med Sci. 2018 Jan-Feb;34(1):62-66. doi: 10.12669/pjms.341.13302. — View Citation

Chandio A, Timmons S, Majeed A, Twomey A, Aftab F. Factors influencing the successful completion of laparoscopic cholecystectomy. JSLS. 2009 Oct-Dec;13(4):581-6. doi: 10.4293/108680809X1258998404560. — View Citation

Jameel SM, Bahaddin MM, Mohammed AA. Grading operative findings at laparoscopic cholecystectomy following the new scoring system in Duhok governorate: Cross sectional study. Ann Med Surg (Lond). 2020 Oct 23;60:266-270. doi: 10.1016/j.amsu.2020.10.035. eCo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laproscopic cholecystectomy Conversion to open with Nassar Grade	Laproscopic cholecystectomy converted to open with Nassar grade ie chance of conversion to open in higher Nassar grade(difficult laparoscopic cholecystectomy)	30 day
Primary	Duration of Surgery		30 day
Primary	Introperative Complication with Nassar Grade	Complication like biliary spillage, stone spillage and bleeding with higher Nassar grade (difficult laparoscopic cholecystectomy)	30 day
Secondary	Total length of stay		30 day