Drain After Elective Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986544
• Other study ID #: Pic63
• Status: Completed
• Phase: N/A
• First received: September 29, 2009
• Last updated: February 18, 2012
• Start date: December 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• elective laparoscopic cholecystectomy

Exclusion Criteria:

• acute cholecystitis, cholangitis, or pancreatitis

• no contraindication for the laparoscopic

• no other additional procedure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• no drain
drain positioned on the skin
• drain positioned
drain positioned in the subhepatic space
• drain not positioned
Drain positioned in the abdominal wall

Locations

Country	Name	City	State
Italy	University of Rome "La Sapienza" - Polo Pontino	Terracina	Latina

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Gurusamy KS, Samraj K, Mullerat P, Davidson BR. Routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006004. Review. Update in: Cochrane Database Syst Rev. 2013;9:CD006004. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	first postoperative day	Yes
Secondary	Number of Participants With Postoperative Complications		1 month	Yes