Back to resultsDrain After Elective Laparoscopic Cholecystectomy
Primary Purpose
Cholelithiasis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
no drain
drain positioned
drain not positioned
Sponsored by
About this trial
This is an interventional treatment trial for Cholelithiasis focused on measuring Laparoscopy, cholecystectomy, drainage
Eligibility Criteria
Inclusion Criteria:
- elective laparoscopic cholecystectomy
Exclusion Criteria:
- acute cholecystitis, cholangitis, or pancreatitis
- no contraindication for the laparoscopic
- no other additional procedure
Sites / Locations
- University of Rome "La Sapienza" - Polo Pontino
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Absence of drain
Drain
Arm Description
drain positioned in the subhepatic space after laparoscopic cholecystectomy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Postoperative Complications
Full Information
NCT ID
NCT00986544
First Posted
September 29, 2009
Last Updated
February 18, 2012
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT00986544
Brief Title
Drain After Elective Laparoscopic Cholecystectomy
Official Title
Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
Laparoscopy, cholecystectomy, drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Absence of drain
Arm Type
Sham Comparator
Arm Title
Drain
Arm Type
Active Comparator
Arm Description
drain positioned in the subhepatic space after laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
no drain
Intervention Description
drain positioned on the skin
Intervention Type
Procedure
Intervention Name(s)
drain positioned
Intervention Description
drain positioned in the subhepatic space
Intervention Type
Procedure
Intervention Name(s)
drain not positioned
Intervention Description
Drain positioned in the abdominal wall
Primary Outcome Measure Information:
Title
Number of Participants With Subhepatic Collection at Ultrasonographic Examination
Description
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 Outcome Measure Information:
Title
Number of Participants With Postoperative Complications
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective laparoscopic cholecystectomy
Exclusion Criteria:
acute cholecystitis, cholangitis, or pancreatitis
no contraindication for the laparoscopic
no other additional procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erasmo Spaziani, PhD
Organizational Affiliation
University of Rome "La Sapienza"- Polo Pontino
Official's Role
Study Director
Facility Information:
Facility Name
University of Rome "La Sapienza" - Polo Pontino
City
Terracina
State/Province
Latina
ZIP/Postal Code
04019
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17943873
Citation
Gurusamy KS, Samraj K, Mullerat P, Davidson BR. Routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006004. doi: 10.1002/14651858.CD006004.pub3.
Results Reference
background
PubMed Identifier
18926516
Citation
Tzovaras G, Liakou P, Fafoulakis F, Baloyiannis I, Zacharoulis D, Hatzitheofilou C. Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled randomized trial. Am J Surg. 2009 Jun;197(6):759-63. doi: 10.1016/j.amjsurg.2008.05.011. Epub 2008 Oct 16.
Results Reference
background
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Drain After Elective Laparoscopic Cholecystectomy
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