Laparoscopic Cholecystectomy:

Cholecystitis Clinical Trial

Official title:

Three-port Versus Four-port Laparoscopic Cholecystectomy: A Prospective Comparative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04107909
• Other study ID #: lapgb
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: December 20, 2023

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: mohammed ali
• Phone: 002101020832073
• Email: mahamedelshreef1993[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Various modifications have been tried in laparoscopic cholecystectomy since its introduction. One, two and three port LC have been performed on limited scale. we aim to compare three port LC with four port LC in patients with cholelithiasis. The main objective of this study is to evaluate the outcome of 3 ports LC for treatment of cholelithiasis by comparing the result with 4 ports LC with respect to safety and efficacy.

Description:

Various modifications have been tried in laparoscopic cholecystectomy since its introduction. One, two and three port LC have been performed on limited scale. we aim was to compare three port LC with four port LC in patients with cholelithiasis. The main objective of this study was to evaluate the outcome of 3 ports LC for treatment of cholelithiasis by comparing the result with 4 To study the efficacy and feasibility of 3 port and 4 port lap cholecystetctomy.

1. To compare the intraoperative and post-operative complications of 3 port and 4 port lap cholecystectomy

1. Operative time,

2. Days of hospital stay.

3. complication

4. post-operative pain ports LC with respect to safety and efficacy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 20, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age of patient between 25 and 65 years

2. Diagnosis of chronic cholecystitis, symptomatic cholelithiasis

Exclusion Criteria:

1. Choledocholithiasis

2. Severe Acute Calculus Pancreatitis

3. Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia) 4 . Previous operation or adhesion

Related Conditions & MeSH terms

• Cholecystitis

Intervention

Procedure:
• laparoscopic cholecystectomy
Both four port and three port LC is performed With the patient in supine position, with the surgeon and assistant on the left side and the monitor on the right side. Head up and right up position is employed during surgery in both the groups. Pneumoperitoneum of 12mmHg is created using open Hassan's method through the umbilical port. In 3 port a 5.5 mm umbilical visiport for 5 mm lens 30 degree A second 10 mm trocar is placed inferior to the sternum at the midline, while the third 5mm trocar is placed 4-5cm inferior to the right costal margin on the right midclavicular line. For the four port LC, additional 5mm port is placed in the sub costal region at the anterior axillary line. Posterior dissection and delineation of The Calot's triangle is done. Then, the cystic artery and cystic duct are identified, isolated, doubly clipped and divided. The gallbladder is removed through the umbilical port using a 10mm gallbladder extractor.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Mühe E. [Laparoscopic cholecystectomy--late results]. Langenbecks Arch Chir Suppl Kongressbd. 1991:416-23. Review. German. — View Citation

Traverso LW. Carl Langenbuch and the first cholecystectomy. Am J Surg. 1976 Jul;132(1):81-2. — View Citation

Trichak S. Three-port vs standard four-port laparoscopic cholecystectomy. Surg Endosc. 2003 Sep;17(9):1434-6. Epub 2003 Jun 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare between the prognosis of three port and four port laproscpic cholecyctectomy		3 years