Evaluation of the efficacy of stent insertion following laparoscopic acute cholecystectomy surgery in a clinical trial.
Design
This study includes 80 patients with acute cholecystitis who qualify for laparoscopic cholecystectomy. Patients will be paired and randomly divided into two groups upon enrollment. Group A will undergo drain placement under the liver after gallbladder removal, while Group B will have their wounds closed without drains.
Settings and conduct
This study was conducted at Isfahan University of Medical Sciences, in the Department of Surgery, using a non-blinded clinical intervention method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Signs of localized inflammation , systemic inflammation , and imaging results suggestive of acute cholecystitis .
Exclusion criteria: symptoms persist for more than 72 hours, if they exhibit signs of gangrenous or emphysematous cholecystitis, if they have a history of heart disease with an ejection fraction below 40%, if they are ineligible for laparoscopic surgery for any reason, or if they have concurrent common bile duct stones with duct dilation or acute pancreatitis.
Intervention groups
Patients aged 18 years and older, diagnosed with acute cholecystitis, presenting within a maximum of 72 hours from symptom onset, will be enrolled in this study.
Main outcome variables
Hospital stay duration; average pain intensity in the initial 24 hours after surgery; post-surgery wound infection rate; relative frequency of post-surgery secretion accumulation requiring drainage; proportion of patients requiring postoperative reoperation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201013049017N4
Registration date:2024-05-02, 1403/02/13
Registration timing:registered_while_recruiting
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Hamid Talebzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 1995
Email address
talebzadeh.h@med.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Drain Placement in Patients Undergoing Acute Laparoscopic Cholecystectomy: A Randomized Clinical Trial Study.
Public title
Studying How the Location of abdominal tube Impacts Individuals Going Through Urgent Laparoscopic Gallbladder Removal.
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is block randomization. Initially, a sequence of random numbers will be generated using online software (sealedenvelope), and then these generated numbers will be divided into 40 blocks of pairs by the same software. Each block will consist of an equal number of intervention and control cases. Therefore, with each block, one patient will be assigned to each group (equally).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committees of School of Medicine-Isfahan University of Medical science
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.MUI.MED.REC.1402.456
Health conditions studied
1
Description of health condition studied
Acute cholecystitis
ICD-10 code
K81.0
ICD-10 code description
Acute cholecystitis
Primary outcomes
1
Description
Length of hospitalization
Timepoint
The last day of the hospitalization
Method of measurement
verifying the patient's hospitalization duration.
2
Description
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.
3
Description
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.
4
Description
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.
5
Description
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 outcomes
1
Description
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.
2
Description
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.
3
Description
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.
4
Description
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.
5
Description
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.
6
Description
The relative frequency of gender among patients with acute cholecystitis who will undergo surgery.
Timepoint
Before operation.
Method of measurement
history taking.
Intervention groups
1
Description
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 milligrams every 8 hours. All patients will undergo complete NPO, hydration, and intravenous therapy, and will undergo laparoscopic cholecystectomy no later than 8 hours after maximum NPO. After general anesthesia, gastric pressure will be reduced using a nasogastric tube, and the operation site will be prepped and draped. Carbon dioxide gas will be insufflated via a Veress needle inserted through the Palmer point, followed by placement of 10 and 5 millimeter trocars in appropriate locations. In this group, no drains will be placed after gallbladder removal, and the wound site will be closed after trocar removal. In case of bile duct tear during dissection or gallbladder removal, or bile leakage into the abdominal cavity, the abdominal cavity will be washed with warm saline using a laparoscopic irrigator after gallbladder removal, and all stones will be removed using a grasper.
Category
Treatment - Surgery
2
Description
Control 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 milligrams every 8 hours. All patients will undergo complete NPO, hydration, and intravenous therapy, and will undergo laparoscopic cholecystectomy no later than 8 hours after maximum NPO. After general anesthesia, gastric pressure will be reduced using a nasogastric tube, and the operation site will be prepped and draped. Carbon dioxide gas will be insufflated via a Veress needle inserted through the Palmer point, followed by placement of 10 and 5 millimeter trocars in appropriate locations. In this group, drain placement will be done for patients after gallbladder removal. In case of bile duct tear during dissection or gallbladder removal, or bile leakage into the abdominal cavity, the abdominal cavity will be washed with warm saline using a laparoscopic irrigator after gallbladder removal, and all stones will be removed using a grasper.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra university hospital
Full name of responsible person
Hamid Talebzadeh
Street address
Al-zahra university hospital, Soffeh Blvd, Isfehan
City
Isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
surgery@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Amin university hospital
Full name of responsible person
Alireza Firozfar
Street address
Amin university hospital, Sonbolestan Alley, Avicenna Street, Isfehan
City
Isfehan
Province
Isfehan
Postal code
5314181486
Phone
+98 31 3445 5051
Email
surgery@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Isfehan medical university, Hezarjerib Ave, Isfehan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
hrc@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Talebzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Al-zahra university hospital, Soffeh Blvd, Isfehan
City
Isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
talebzadeh.h@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Talebzadeh
Position
Assistant Professor,Subspeciality of thoracic surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1995
Fax
Email
talebzadeh.h@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Talebzadeh
Position
Assistant Professor,Subspeciality of thoracic surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1995
Fax
Email
talebzadeh.h@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data, pre- and post-intervention assessment results including primary outcome and secondary outcomes will be collected.
When the data will become available and for how long
Simultaneously with the publication of the results.
To whom data/document is available
All individuals reading the article.
Under which criteria data/document could be used
For comparison with similar studies.
From where data/document is obtainable
Referencing the publisher's website.
What processes are involved for a request to access data/document
Individuals, after visiting the publisher's website and submitting a request, can access documents and data files within less than one month following review by experts.