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Drain After Elective Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00986544
First Posted: September 30, 2009
Last Update Posted: March 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza
  Purpose
The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.

Condition Intervention
Cholelithiasis Procedure: no drain Procedure: drain positioned Procedure: drain not positioned

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Erasmo Spaziani, University of Roma La Sapienza:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Number of Participants With Postoperative Complications [ Time Frame: 1 month ]

Enrollment: 106
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Absence of drain Procedure: no drain
drain positioned on the skin
Procedure: drain not positioned
Drain positioned in the abdominal wall
Active Comparator: Drain
drain positioned in the subhepatic space after laparoscopic cholecystectomy
Procedure: drain positioned
drain positioned in the subhepatic space

Detailed 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
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective laparoscopic cholecystectomy

Exclusion Criteria:

  • acute cholecystitis, cholangitis, or pancreatitis
  • no contraindication for the laparoscopic
  • no other additional procedure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986544


Locations
Italy
University of Rome "La Sapienza" - Polo Pontino
Terracina, Latina, Italy, 04019
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Director: Erasmo Spaziani, PhD University of Rome "La Sapienza"- Polo Pontino
  More Information

Publications:
Responsible Party: Erasmo Spaziani, MD; PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT00986544     History of Changes
Other Study ID Numbers: Pic63
First Submitted: September 29, 2009
First Posted: September 30, 2009
Results First Submitted: January 16, 2012
Results First Posted: March 23, 2012
Last Update Posted: March 23, 2012
Last Verified: February 2012

Keywords provided by Erasmo Spaziani, University of Roma La Sapienza:
Laparoscopy
cholecystectomy
drainage

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical