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Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery (CHOLEGAS)

I

Italian Research Group for Gastric Cancer

Status

Completed

Conditions

Gastric Cancer

Treatments

Procedure: cholecystectomy

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT00757640
Firenze 1

Details and patient eligibility

About

The patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.

Full description

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery.

Enrollment

150 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing standard gastric surgery for cancer

Exclusion criteria

  • gallbladder disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 2 patient groups

B
No Intervention group
Description:
no cholecystectomy
A
Experimental group
Description:
cholecystectomy
Treatment:
Procedure: cholecystectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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