Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Drain After Elective Laparoscopic Cholecystectomy

This study has been completed.
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza Identifier:
First received: September 29, 2009
Last updated: February 18, 2012
Last verified: February 2012
The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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 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

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

Inclusion Criteria:

  • elective laparoscopic cholecystectomy

Exclusion Criteria:

  • acute cholecystitis, cholangitis, or pancreatitis
  • no contraindication for the laparoscopic
  • no other additional procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00986544

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

Responsible Party: Erasmo Spaziani, MD; PhD, University of Roma La Sapienza 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

Keywords provided by University of Roma La Sapienza:

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical processed this record on April 25, 2017