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Clinical Trials/CTRI/2025/02/080970
CTRI/2025/02/080970
Not yet recruiting
Not Applicable

A Randomized Control Trial to assess feasibility of early cholecystectomy in patients of acute cholecystitis verses interval cholecystectomy.

UPUMS Saifai Etawah1 site in 1 country100 target enrollmentStarted: March 3, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
UPUMS Saifai Etawah
Enrollment
100
Locations
1
Primary Endpoint
TO ESTABLISH THE FEASIBILITY OF EARLY CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS

Overview

Brief Summary

Ozkardeş AB et al (2014), conducted a study to compare the clinical outcome and cost of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Sixty patients with acute cholecystitis were randomized into early (within 24 hours of admission) or delayed (after 6–8 weeks of conservative treatment) laparoscopic cholecystectomy groups. There was no significant difference between study groups in terms of operation time and rates for conversion to open cholecystectomy. On the other hand, total hospital stay was longer and total costs were higher in the delayed laparoscopic cholecystectomy group. Intraoperative and postoperative complications were recorded in 8 patients in the early laparoscopic cholecystectomy group, whereas no complications occurred in the delayed laparoscopic cholecystectomy group.Despite intraoperative and postoperative complications being associated more with early laparoscopic cholecystectomy compared with delayed intervention, early laparoscopic cholecystectomy should be preferred for treatment of acute cholecystitis because of its advantages of shorter hospital stay and lower cost.

Ahmad UJ et al (2020), conducted a study that total 100 patients with clinical diagnosis of acute cholecystitis, admitted in the surgical wards of Gauhati Medical College and Hospital during the period of 1st July 2017 to 30th June 2018 were selected for the study. 40 patients underwent early cholecystectomy (within 7 days of onset of symptoms) and 60 patients underwent elective or late cholecystectomy (after a gap of 6-8 weeks from the acute attack). In the present series the average duration of surgery was 90.37±11.96 minutes in the early group and 65.3±7.83 minutes for the elective group which is found to be statistically significant (p value<0.05). In the early surgery group 8.33% required conversion to open surgery. In the elective surgery group 3.63% required conversion. Wound infection, biliary leakage, bile duct injury, and respiratory tract infection was found to be statistically not significant between the two groups. Early cholecystectomy is feasible and safe for acute cholecystitis and is better method of treatment because of its shorter hospital stay, which is a major economic benefit to both the patient and health care system.

"To assess the feasibility of early cholecystectomy in the prevention of intraoperative complications, post operative complications, cost effectiveness, as compared to interval cholecystectomy"

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
16.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • all patients with symptomatic gallstone disease with recent onset within 72 hours of typical pain.
  • Grade 1 Tokyo guidelines.

Exclusion Criteria

  • Patient who are not giving consent to be the part of study.
  • Patient with pancreatitis.
  • Patient of acute cholecystitis after 72 hours of symptom onset.

Outcomes

Primary Outcomes

TO ESTABLISH THE FEASIBILITY OF EARLY CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS

Time Frame: WITHIN 72 HOUR OF STARTING OF THE SYMPTOMS OF ACUTE CHOLECYSTITIS

Secondary Outcomes

  • To assess the feasibility of early cholecystectomy as compared to interval cholecystectomy(At 6 week intervel)

Investigators

Sponsor
UPUMS Saifai Etawah
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Asha Verma

UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES

Study Sites (1)

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