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

S

Sohag University

Status

Invitation-only

Conditions

Cholecystitis, Chronic

Treatments

Procedure: Laparoscopic Cholecystectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06264115
Soh-Med-24-01-05MS

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

Three ports Laparoscopic Cholecystectomy group
Treatment:
Procedure: Laparoscopic Cholecystectomy
Four ports Laparoscopic Cholecystectomy group
Treatment:
Procedure: Laparoscopic Cholecystectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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