Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS

NCT ID: NCT04994171

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-06-01

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.

Conditions

Laparoscopic Cholecystectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All patients undergoing laparoscopic cholecystectomy

Exclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Nirmal Prasad Sah

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nirmal Prasad sah

Dharān, Koshi, Nepal

Countries

Nepal

References

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.

Reference Type: BACKGROUND

PMID: 20202401 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29643880 (View on PubMed)

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. eCollection 2020 Dec.

Reference Type: RESULT

PMID: 33204417 (View on PubMed)

Other Identifiers

1758/020

Identifier Type: -

Identifier Source: org_study_id