Laparoscopic Cholecystectomy:

NCT ID: NCT04107909

Last Updated: 2019-09-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-30

Study Completion Date

2023-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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3 ports

3port operation

Group Type OTHER

laparoscopic cholecystectomy

Intervention Type PROCEDURE

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.

4 port

4 port operation

Group Type OTHER

laparoscopic cholecystectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ali Abdelfatah Elshreef

general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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mohammed ali

Role: CONTACT

002101020832073

References

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

Reference Type BACKGROUND
PMID: 1838946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 782269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12799892 (View on PubMed)

Other Identifiers

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lapgb

Identifier Type: -

Identifier Source: org_study_id

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