Drain After Elective Laparoscopic Cholecystectomy

University of Roma La Sapienza106 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

106

Conditions

Cholelithiasis

Interventions

no drainPROCEDURE

drain positioned on the skin

drain positionedPROCEDURE

drain positioned in the subhepatic space

drain not positionedPROCEDURE

Drain positioned in the abdominal wall

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * elective laparoscopic cholecystectomy Exclusion Criteria: * acute cholecystitis, cholangitis, or pancreatitis * no contraindication for the laparoscopic * no other additional procedure

Locations (1)

University of Rome "La Sapienza" - Polo Pontino

Terracina, Latina, Italy

Outcomes

Primary Outcomes

Number of Participants With Subhepatic Collection at Ultrasonographic Examination

An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.

Time frame: first postoperative day

Secondary Outcomes

Number of Participants With Postoperative Complications

Time frame: 1 month

Data from ClinicalTrials.gov

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