Can Laparoscopic Cholecystectomy Difficulty Score Predict Difficult Surgery

NCT04282759 | Completed

• 1 other identifier: KonyaHPRC
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy is the gold standard treatment method in symptomatic gallstone disease. However, complications that develop due to being a technical procedure tend to be more complex and more morbid-estimating how difficult the surgery will be before the operation will enable us to be more prepared both in terms of patient counseling and surgical team selection. Such a prediction will minimize the risk of complications and morbidity. In our study, investigators used the scoring system "How to predict difficult laparoscopic cholecystectomy? Proposal for a simple preoperative scoring system?" which was published in "The American Journal of Surgery" in November 2016. Investigators wanted to evaluate prospectively adequate "Laparoscopic Cholecystectomy Difficulty Score," which was developed retrospectively, in determining the surgical difficulty preoperatively.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Numerical recording of Difficulty Score of Laparoscopic Cholecystectomy (DSLC)

  Laparoscopic cholecystectomy scores of patients included in the study will be recorded. The relationship between the scoring system and the fact that the cases are easy or difficult will be analyzed statistically, in which predictive values determine the difficulty of the operation. The study will be terminated with the completion of the analysis.

  The period of the study is between 1 March 2020 and 15 August 2020.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is comprised of patients between the ages of 18-100, who are referred to the general surgery clinic for laparoscopic cholecystectomy.

You may qualify if:

• Patients who will be operated for biliary colic, chronic cholecystitis or symptomatic cholelithiasis,
• Patients who have been treated with antibiotics before with the diagnosis of cholecystitis and have been planned for elective cholecystectomy,
• Patients diagnosed with acute cholecystitis according to Tokyo criteria and cholecystectomy planned due to acute cholecystitis

You may not qualify if:

• Patients under the age of 18,
• Patients over 100 years old,
• Patients diagnosed with choledocholithiasis with magnetic resonance cholangiopancreatography (MRCP),
• Patients with cholangitis
• Patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP),
• Patients who have undergone biliary system intervention before,
• Patients scheduled for operation open cholecystectomy

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (2)

• Bourgouin S, Mancini J, Monchal T, Calvary R, Bordes J, Balandraud P. How to predict difficult laparoscopic cholecystectomy? Proposal for a simple preoperative scoring system. Am J Surg. 2016 Nov;212(5):873-881. doi: 10.1016/j.amjsurg.2016.04.003. Epub 2016 Jun 1.

  PMID: 27329073 BACKGROUND

• Sugrue M, Coccolini F, Bucholc M, Johnston A; Contributors from WSES. Intra-operative gallbladder scoring predicts conversion of laparoscopic to open cholecystectomy: a WSES prospective collaborative study. World J Emerg Surg. 2019 Mar 14;14:12. doi: 10.1186/s13017-019-0230-9. eCollection 2019.

  PMID: 30911325 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: March 1, 2020
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

TU (1)