Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience

Cholecystitis, Chronic Clinical Trial

Official title:

Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06264115
• Other study ID #: Soh-Med-24-01-05MS
• Status: Enrolling by invitation
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy

Description:

To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy Randomized clinical trial comparative study will be carried out on 50 patients underwent laparoscopic cholecystectomy in general surgical department, Sohag University. An informed written consent will be obtained from the patients. Every patient will receive an explanation of the purpose of the study and will have a secret code number. Research results will be only used for scientific purposes. Any unexpected risks appearing during the course of research will be clarified to the participants and to the ethical committee on time.

Patients will be randomly classified into two equal groups; 25 patients will be enrolled in each group using computer generated random number in closed sealed envelope.

Group I (3-ports): 25 patients undergo a three-port LC. Group II (4-ports): 25 patients undergo a four-port LC. All patients will be subjected to thorough history taking (age, sex, symptoms, and duration of symptoms) and full clinical evaluation.

Abdominal ultrasound will be done in all patients. Baseline laboratory (complete blood count and coagulation profile) will be ordered in all patients.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 to 75 years.

• Both sexes.

• Patient with clinical, laboratory and/or radiological evidence that is a candidate for cholecystectomy operation.

Exclusion Criteria:

• Patient's refusal.

• Bile duct stones.

• History of obstructive jaundice.

• Severe acute calculus pancreatitis.

• Severe co-morbid diseases (uncontrolled diabetes, hypertension, and severe direct hyperbilirubinemia).

• Prior surgery or adhesion.

• Radical cholecystectomy.

• Pregnancy.

• Malignancy.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Chronic

Intervention

Procedure:
• Laparoscopic Cholecystectomy
Using Three Ports or Four Ports for Laparoscopic Cholecystectomy

Locations

Country	Name	City	State
Egypt	Sohag university	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total postoperative morphine consumption		one year
Other	Time of first analgesic		one year
Primary	Postoperative pain score	Measurement of postoperative pain in both groups according to visual analogue scale The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').; Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).	One year
Secondary	Operative time		One year
Secondary	length of hospital stay		one year