NCT04107909

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

September 25, 2019

Last Update Submit

September 26, 2019

Conditions

Cholecystitis

Outcome Measures

Primary Outcomes (1)

  • compare between the prognosis of three port and four port laproscpic cholecyctectomy

    3 years

Study Arms (2)

3 ports

OTHER

3port operation

Procedure: laparoscopic cholecystectomy

4 port

OTHER

4 port operation

Procedure: laparoscopic cholecystectomy

Interventions

laparoscopic cholecystectomyPROCEDURE

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.

3 ports4 port

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of patient between 25 and 65 years
  • Diagnosis of chronic cholecystitis, symptomatic cholelithiasis

You may not qualify if:

  • Choledocholithiasis
  • Severe Acute Calculus Pancreatitis
  • Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia) 4 . Previous operation or adhesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Muhe E. [Laparoscopic cholecystectomy--late results]. Langenbecks Arch Chir Suppl Kongressbd. 1991:416-23. doi: 10.1007/978-3-642-95662-1_189. German.

    PMID: 1838946BACKGROUND

  • Traverso LW. Carl Langenbuch and the first cholecystectomy. Am J Surg. 1976 Jul;132(1):81-2. doi: 10.1016/0002-9610(76)90295-6.

    PMID: 782269BACKGROUND

  • Trichak S. Three-port vs standard four-port laparoscopic cholecystectomy. Surg Endosc. 2003 Sep;17(9):1434-6. doi: 10.1007/s00464-002-8713-1. Epub 2003 Jun 13.

    PMID: 12799892BACKGROUND

MeSH Terms

Conditions

Cholecystitis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Central Study Contacts

mohammed ali

CONTACT

002101020832073mahamedelshreef1993@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general surgery

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

December 30, 2019

Primary Completion

December 30, 2022

Study Completion

December 20, 2023

Last Updated

September 27, 2019

Record last verified: 2019-09