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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
Results First Received: January 16, 2012  
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
Condition: Cholelithiasis
Interventions: Procedure: no drain
Procedure: drain positioned
Procedure: drain not positioned

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From December 1, 2009 to December 31, 2010 patients were submitted to laparoscopic cholecystectomy in Hospital “P.Colombo”, Velletri, Italy; University of Rome “La Sapienza”- Polo Pontino, Terracina, Italy; Obafemi Awolowo University, Ile-Ife, Nigeria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with acute cholecystitis, cholangitis, or pancreatitis were excluded. If intraoperative common bile duct exploration or any other additional procedure were performed, patients were also excluded

Reporting Groups
  Description
Absence of Drain After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
Drain drain positioned in the subhepatic space after laparoscopic cholecystectomy

Participant Flow:   Overall Study
    Absence of Drain     Drain  
STARTED     53     53  
COMPLETED     53     53  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Absence of Drain After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
Drain drain positioned in the subhepatic space after laparoscopic cholecystectomy
Total Total of all reporting groups

Baseline Measures
    Absence of Drain     Drain     Total  
Number of Participants  
[units: participants]
 		  53     53     106  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     38     34     72  
>=65 years     15     19     34  
Age  
[units: years]
Mean ± Standard Deviation 		  47.1  ± 16.7     48.6  ± 14.2     47.8  ± 15.4  
Gender  
[units: participants]
 		     
Female     40     42     82  
Male     13     11     24  
Region of Enrollment  
[units: participants]
 		     
Italy     53     53     106  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Subhepatic Collection at Ultrasonographic Examination   [ Time Frame: first postoperative day ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Postoperative Complications   [ Time Frame: 1 month ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Marcello Picchio
Organization: Department of Surgery, Hospital “P. Colombo”, Via Orti Ginnetti 7, 00049 Velletri (Rome), Italy
phone: +39696102228
e-mail: marcellopicchio@libero.it


Publications:


Responsible Party: Erasmo Spaziani, 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