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Enrolling by invitationNCT06264115Updated Feb 20, 2024

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

An observational study in Cholecystitis, Chronic, sponsored by Sohag University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cholecystitis, Chronic

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03

In context

Cholecystitis

266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 90 observational studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

patients undergoing laparoscopic cholecystectomy

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Three ports Laparoscopic Cholecystectomy group

    Procedure: Laparoscopic Cholecystectomy

  • Four ports Laparoscopic Cholecystectomy group

    Procedure: Laparoscopic Cholecystectomy

Interventions

  • ProcedureLaparoscopic Cholecystectomy

    Using Three Ports or Four Ports for Laparoscopic Cholecystectomy

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: One year

Secondary outcomes

  1. Operative time

    Time frame: One year

  2. length of hospital stay

    Time frame: one year

Other outcomes

  1. Total postoperative morphine consumption

    Time frame: one year

  2. Time of first analgesic

    Time frame: one year

07

Study locations

1 site
  • Sohag university
    Sohag, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06264115
Lead sponsor
Sohag University
Responsible party
Mikel Mokhtar Shafik (Resident of general surgery of sohag university hospital, Sohag University) — Principal investigator
First posted
Feb 16, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Feb 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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