Clinical trial NCT04994171: Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS
Official title: Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Cholecystectomy
Keywords: Surgery
Laparoscopic
Cholecystectomy
Cholecystitis
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients

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.

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

Primary outcomes:
measure: Laproscopic cholecystectomy Conversion to open with Nassar Grade
timeFrame: 30 day
measure: Duration of Surgery
timeFrame: 30 day
measure: Introperative Complication with Nassar Grade
timeFrame: 30 day
Secondary outcomes:
measure: Total length of stay
timeFrame: 30 day
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: Nirmal Prasad sah
state: Province 1
Study officials:
References:
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.
citation: 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.
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. eCollection 2020 Dec.