Cholecystitis, Chronic
Conditions
Brief summary
To compare the outcomes of three ports and four ports 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.
Interventions
PROCEDURELaparoscopic Cholecystectomy
Using Three Ports or Four Ports for Laparoscopic Cholecystectomy
Sponsors
Sohag University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score | One year | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Operative time | One year |
| length of hospital stay | one year |
Other
| Measure | Time frame |
|---|---|
| Total postoperative morphine consumption | one year |
| Time of first analgesic | one year |
Countries
Egypt
Outcome results
None listed