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Studying How the Location of abdominal tube Impacts Individuals Going Through Urgent Laparoscopic Gallbladder Removal.

Investigating the Effect of Drain Placement in Patients Undergoing Acute Laparoscopic Cholecystectomy: A Randomized Clinical Trial Study.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201013049017N4
Enrollment
80
Registered
2024-05-02
Start date
2024-04-03
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute cholecystitis. Acute cholecystitis

Interventions

Intervention 1: Intervention group: In this group, patients diagnosed with acute cholecystitis will receive treatment upon study entry with ceftriaxone 1 gram every 8 hours and metronidazole 500 milli

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Signs of local inflammation, like a positive Murphy's sign, the presence of a mass, tenderness, and pain in the right upper quarter of the abdomen. Signs of systemic inflammation, such as fever above 38 degrees Celsius, elevated CRP levels, and increased white blood cell count. Imaging findings such as a positive ultrasound Murphy's sign, gallbladder wall thickness greater than or equal to 4 mm, enlargement of the gallbladder exceeding 8 cm in the long axis and 4 cm in the short axis. It has been a maximum of 72 hours since the symptoms began.

Exclusion criteria

Exclusion criteria: The patient's symptoms have been present for more than 72 hours. Patient exhibiting signs of gangrenous cholecystitis or emphysematous cholecystitis. Patients with a history of heart disease and an ejection fraction (EF) less than 40%. patient ineligible for laparoscopic surgery due to any contraindication. patients presenting concurrently with common bile duct stones and duct dilation or acute pancreatitis.

Design outcomes

Primary

MeasureTime frame
Length of hospitalization. Timepoint: The last day of the hospitalization. Method of measurement: verifying the patient's hospitalization duration.;Mean pain intensity during the initial 24 hours following surgery. Timepoint: The initial 24 hours post-surgery. Method of measurement: Score on the Visual Analog Scale (VAS) questionnaire.;The proportion of wound infections occurring after surgery. Timepoint: 24 hours post-surgery, 10-12 days post-surgery, and one month post-surgery. Method of measurement: History and examination.;The relative frequency of secretion accumulation requiring drainage after surgery. Timepoint: 24 hours post-surgery, and one month post-surgery. Method of measurement: Utilization of hepatic and bile duct sonography.;The proportion of patients requiring postoperative reoperation. Timepoint: 24 hours post-surgery, and one month post-surgery. Method of measurement: History, examination, and utilization of hepatic and bile duct sonography.

Secondary

MeasureTime frame
Average time elapsed from the onset of symptoms to surgery. Timepoint: 24 hours post-surgery, 10-12 days post-surgery, and one month post-surgery. Method of measurement: calculating the duration.;The relative frequency of comorbidities occurrence in patients with acute cholecystitis who will undergo surgery. Timepoint: Before operation. Method of measurement: History and physical examination.;The relative frequency of smoking occurrence in patients with acute cholecystitis who will undergo surgery. Timepoint: Before operation. Method of measurement: History and physical examination.;The relative frequency of alcohol consumption in patients with acute cholecystitis who will undergo surgery. Timepoint: Before operation. Method of measurement: History and physical examination.;The relative frequency of abnormal body mass index (BMI) in patients with acute cholecystitis who will undergo surgery. Timepoint: Before operation. Method of measurement: History and physical examination.;The relative frequency of gender among patients with acute cholecystitis who will undergo surgery. Timepoint: Before operation. Method of measurement: history taking.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Talebzadeh

Esfahan University of Medical Sciences

talebzadeh.h@med.mui.ac.ir+98 31 3620 2020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026