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Drain After Elective Laparoscopic Cholecystectomy

U

University of Roma La Sapienza

Status

Completed

Conditions

Cholelithiasis

Treatments

Procedure: no drain
Procedure: drain positioned
Procedure: drain not positioned

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.

Full description

After laparoscopic gallbladder removal patients are randomized to have a suction drain positioned in the subhepatic space or to have a sham drain in the subhepatic space. The primary outcome measure will be the presence of subhepatic fluid collection at ultrasonographic examination on the first postoperative day. Secondary outcome measures will be postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting and morbidity

Enrollment

106 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • elective laparoscopic cholecystectomy

Exclusion criteria

  • acute cholecystitis, cholangitis, or pancreatitis
  • no contraindication for the laparoscopic
  • no other additional procedure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

106 participants in 2 patient groups

Absence of drain
Sham Comparator group
Treatment:
Procedure: no drain
Procedure: drain not positioned
Drain
Active Comparator group
Description:
drain positioned in the subhepatic space after laparoscopic cholecystectomy
Treatment:
Procedure: drain positioned

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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