The comparative study of the complications of laparoscopic cholecystectomy surgery in two methods of entering the first port supraumbilically vs infraumbilically.

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240429061593N1

Enrollment

Registered

2024-05-04

Start date

2024-04-29

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

Cholelithiasis. Calculus of gallbladder without cholecystitis

Interventions

Intervention 1: 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 ston

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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.;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.;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.	—

Measure

Time frame

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.;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.;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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDavood Mahdipour

Ardabil University of Medical Sciences

drmahda@yahoo.com+98 45 3323 4772

Outcome results

None listed

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