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Drain After Elective Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00986544
First received: September 29, 2009
Last updated: February 18, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Gallstones
U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Participants With Subhepatic Collection at Ultrasonographic Examination [ Time Frame: first postoperative day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 29, 2009
Results First Received: January 16, 2012
Last Updated: February 18, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on June 13, 2013