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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cholecystitis, Chronic
• Intervention / Treatment: Procedure: Laparoscopic Cholecystectomy

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

patients undergoing laparoscopic cholecystectomy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Three ports Laparoscopic Cholecystectomy group	Procedure: Laparoscopic Cholecystectomy; Using Three Ports or Four Ports for Laparoscopic Cholecystectomy
Four ports Laparoscopic Cholecystectomy group	Procedure: Laparoscopic Cholecystectomy; Using Three Ports or Four Ports for Laparoscopic Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Operative time	One year
length of hospital stay	one year

Other Outcome Measures

Outcome Measure	Time Frame
Total postoperative morphine consumption	one year
Time of first analgesic	one year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis
• Other Study ID Numbers: Soh-Med-24-01-05MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No