The comparative study of the complications of laparoscopic cholecystectomy (infection, hematoma and surgical site hernia) in two methods of entering the first port supraumbilically vs infraumbilically in patients with symptomatic cholelithiasis.
Comparison of complications such as the presence of hematoma and infection in the first visit 7 to 10 days after the operation and examination for hernia in the first trocar insertion site 6 months after the operation with clinical examination in two methods of entering the first trocar above the navel and below the navel in laparoscopic cholecystectomy during one year.
Design
In both groups of 35 people with symptoms of gallstones, standard laparoscopic cholecystectomy will be performed, with the difference that the entry point of the first trocar for the entry of the endoscope will be above the navel in the first group and below the navel in the second group. In order to determine the sample size, if we consider the confidence percentage to be 95% and the power of the test to be 90%, the number of patients in each group will be 35 people and a total of 70 people.
Settings and conduct
The study will be conducted on patients with symptomatic cholelithiasis in the operating room of Imam Khomeini Hospital in Ardabil.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18-70 years with a BMI of 18 to 32 undergoing laparoscopic cholecystectomy surgery will be examined during one year.
Exclusion criteria: surgery duration more than 45 minutes, BMI less than 18 and more than 32, patients with immunodeficiency, diabetes, kidney diseases, COPD, patients with smoking, patients with surgery for reasons other than cholelithiasis, cholecystitis and hydrops and choledocholithiasis.
Intervention groups
The entry point of the first trocar for the entry of the endoscope will be above the navel in the first group and below the navel in the second group.
Main outcome variables
Choosing the method of starting laparoscopy with the entry site that has less complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240429061593N1
Registration date:2024-05-04, 1403/02/15
Registration timing:registered_while_recruiting
Last update:2024-05-04, 1403/02/15
Update count:0
Registration date
2024-05-04, 1403/02/15
Registrant information
Name
Davood Mahdipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 4772
Email address
drmahda@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-29, 1403/02/10
Expected recruitment end date
2024-07-31, 1403/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of the complications of laparoscopic cholecystectomy (infection, hematoma and surgical site hernia) in two methods of entering the first port supraumbilically vs infraumbilically in patients with symptomatic cholelithiasis.
Public title
The comparative study of the complications of laparoscopic cholecystectomy surgery in two methods of entering the first port supraumbilically vs infraumbilically.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-70 years with a BMI of 18 to 32 undergoing laparoscopic cholecystectomy due to cholelithiasis will be examined in Imam Khomeini Hospital during two years.
The surgeon will be a single person. The sample size is calculated to be at least 70 people.
Exclusion criteria:
If the duration of the surgery lasts more than 45 minutes, the patient will be excluded from the study due to the possibility of "hard gall bladder".
If the BMI is less than 18 and above 32, the patient will be excluded from the study.
Patients with immunodeficiency, diabetes, Kidney patients, COPD, patients with smoking, patients with surgery due to reasons other than cholelithiasis.
Cases of cholecystitis and hydops, and the presence of stones in the gallbladder are also excluded from the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed written consent, the patients were randomly divided into two groups A: (superior umbilical trocar in laparoscopic cholecystectomy) and group B: (below umbilical trocar in cholecystectomy) using sealed envelopes. laparoscopic) will be divided. The codes of the people entered in the research remain closed until the end of the study. After selecting the samples, none of the sample people and statistical evaluators will know about randomization and the process of allocation to groups.
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
Ethics Committee of Ardabil University of Medical Sciences
Street address
Fatemi Hospital Secretariat, Shariati Square
City
Ardabil
Province
Ardabil
Postal code
5614733775
Approval date
2023-11-20, 1402/08/29
Ethics committee reference number
IR.ARUMS.REC.1403.024
Health conditions studied
1
Description of health condition studied
Cholelithiasis
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
Comparing the percentage of surgical site infection in the entry of the first trocar from above and below the umbilicus
Timepoint
Comparison of the percentage of surgical site infection in the first visit 7 to 10 days after surgery
Method of measurement
By physical examination
2
Description
Comparison of hematoma percentage of the operation site in the entry of the first trocar from above and below the umbilicus
Timepoint
Comparison of the percentage of surgical site hematoma in the first visit 7 to 10 days after surgery
Method of measurement
By physical examination
3
Description
Comparison of hernia at the entry site of the first trocar from above and below the umbilicus
Timepoint
Comparison of the percentage of hernia at the insertion site of the first trocar from above and below the umbilicus 6 months after the operation
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
In the first group, the first laparoscopic trocar will be inserted from above the navel. Laparoscopic cholecystectomy is the method of choice to remove the gall bladder containing stones with clinical symptoms such as abdominal pain in the world. To start the laparoscopy, which is performed with a device called a laparoscope. Laparoscopic surgery is also called minimally invasive surgery and keyhole surgery and is one of the new surgical techniques. This type of surgery has several advantages over preventive surgery. These benefits include less pain due to smaller incisions, less bleeding, and a shorter recovery period. The main element is the use of a laparoscope, which is a long blurred cable system that has the ability to observe and influence the desired area and can be twisted and controlled from a distant area. By creating three or four limited incisions (with a diameter of about one centimeter) on the surface of the abdominal skin, we insert the endoscope tube, which has a camera at the top, into the abdomen through a special device called a port or trocar. The operation site is illuminated with cold light (such as halogen). The first trocar is usually inserted from above or below the navel, then the camera enters the abdomen from it, and the next trocars are inserted under the direct view of the camera through certain obstructions in the abdominal wall. The most common complications associated with laparoscopy include bleeding, infection, hematoma, hernia at the trocar insertion site, and damage to the abdominal organs, although the risk of these complications in this method is much lower than in open surgeries. The duration of this surgery usually lasts between 30 and 60 minutes. Then, after the surgery is completed, all the devices, which include special tools for taking tissue, cutting, applying clips and establishing hemostasis, are removed from the abdomen and the trocars that were inserted into the abdominal wall at the beginning of the operation are removed and interfere with the operation of stitches and dressings. and the patient is brought to consciousness by the anesthesiologist.
Category
Treatment - Surgery
2
Description
In the second group, the first laparoscopic trocar will be inserted below the navel. All procedures in the second group are exactly the same as the first group, with the difference that the first trocar, which was explained in the first group, will be inserted from below the navel instead of above the navel. Both methods above and below the navel have been suggested in the books, but the written study that has weighed the mentioned complications of the two methods together has not been done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Davood Mahdipour
Street address
Shaheed Noee Aghdam brothers avenue
City
Ardabil
Province
Ardabil
Postal code
5619647531
Phone
+98 45 3325 1401
Fax
+98 45 3326 2140
Email
emamhe@arums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Amir Ahmad Arabzadeh
Street address
Daneshgah avenue
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3353 4798
Email
portal@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Davood Mahdipour
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No.28, Sohrabi lane, Danesh Avenue
City
Ardabil
Province
Ardabil
Postal code
5614715686
Phone
+98 45 3323 4772
Email
drmahda@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Davood Mahdipour
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
no. 28, Sohrabi lane, Danesh Avenue
City
Ardabil
Province
Ardabil
Postal code
5614715686
Phone
+98 45 3323 4772
Email
drmahda@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Davood Mahdipour
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
no.28, Sohrabi lane, Danesh avenue
City
Ardabil
Province
Ardabil
Postal code
5614715686
Phone
+98 45 3323 4772
Email
drmahda@yahoo.com
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
A part of the data such as the information related to the main outcome or the like can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The documentation will be useful for surgeons to reduce laparoscopic complications.
From where data/document is obtainable
Correspondence with the registrant, Dr. Davood Mahdipour.
drmahda@yahoo.com
What processes are involved for a request to access data/document
After ensuring that the data will be used in similar studies, the request will be answered within one month.