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OpenTrials
Completed

NCT Number: NCT00986544

Drain After Elective Laparoscopic Cholecystectomy

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

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rome "La Sapienza" - Polo Pontino

Terracina, Latina, 04019, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective laparoscopic cholecystectomy

Exclusion criteria

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

Treatment and study plan

No Drain

Procedure

drain positioned on the skin

drain positioned

Procedure

drain positioned in the subhepatic space

drain not positioned

Procedure

Drain positioned in the abdominal wall

Primary outcomes

  1. Number of Participants With Subhepatic Collection at Ultrasonographic Examination

    Time frame: first postoperative day

    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.

Secondary outcomes

  1. Number of Participants With Postoperative Complications

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2009
Registry last updated
Mar 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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