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

NCT ID: NCT06264115

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cholecystitis, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Three ports Laparoscopic Cholecystectomy group

Laparoscopic Cholecystectomy

Intervention Type PROCEDURE

Using Three Ports or Four Ports for Laparoscopic Cholecystectomy

Four ports Laparoscopic Cholecystectomy group

Laparoscopic Cholecystectomy

Intervention Type PROCEDURE

Using Three Ports or Four Ports for Laparoscopic Cholecystectomy

Interventions

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Laparoscopic Cholecystectomy

Using Three Ports or Four Ports for Laparoscopic Cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mikel Mokhtar Shafik

Resident of general surgery of sohag university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-Med-24-01-05MS

Identifier Type: -

Identifier Source: org_study_id

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