Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-04-01

Brief Summary

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This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.

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Detailed Description

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The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.

This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A \& B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.

Conditions

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Acute Calculous Cholecystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

62 patients with acute calcular cholecystitis are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to onset of symptoms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LC within 72 hours of disease onset

Immediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits

LC after 72 hours of disease onset

Late laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits

Interventions

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Laparoscopic cholecystectomy

The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count \> 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
2. Initial surgical management planned for immediate laparoscopic cholecystectomy.
3. Patients who are fit for laparoscopy and general anesthesia.
4. Patient who agree to provide short term outcome data and agree to provide contact information.

Exclusion Criteria

1. Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
2. Patients with other associated abdominal pathology.
3. Patients with any previous abdominal surgery or any significant systemic disease.
4. Septic shock.
5. Pregnancy/ Breast-feeding mothers.
6. Participation in an additional drug or device study and inability to offer informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No