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

NCT06264115 | Enrolling By Invitation

• 1 other identifier: Soh-Med-24-01-05MS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholecystitis, Chronic

Outcome Measures

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).

  One year

Secondary Outcomes (2)

• Operative time

  One year

• length of hospital stay

  one year

Other Outcomes (2)

• Total postoperative morphine consumption

  one year

• Time of first analgesic

  one year

Study Arms (2)

Three ports Laparoscopic Cholecystectomy group

Procedure: Laparoscopic Cholecystectomy

Four ports Laparoscopic Cholecystectomy group

Procedure: Laparoscopic Cholecystectomy

Interventions

Laparoscopic Cholecystectomy PROCEDURE

Using Three Ports or Four Ports for Laparoscopic Cholecystectomy

Four ports Laparoscopic Cholecystectomy group; Three ports Laparoscopic Cholecystectomy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing laparoscopic cholecystectomy

You may qualify if:

• Age 18 to 75 years.
• Both sexes.
• Patient with clinical, laboratory and/or radiological evidence that is a candidate for cholecystectomy operation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university

Sohag, Egypt

Location

MeSH Terms

Conditions

Cholecystitis; Bronchiolitis Obliterans Syndrome

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of general surgery of sohag university hospital

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 16, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

EG (1)