Drain After Elective Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Cholelithiasis
• Interventions: Procedure: drain positioned; Procedure: no drain; Procedure: drain not positioned

• Registration Number: NCT00986544
• Lead Sponsor: University of Roma La Sapienza

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

Study Timeline

• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2009-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-01-16
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-18
• Last Update Submitted: 2012-02-18
• Results First Posted: 2012-03-23
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• elective laparoscopic cholecystectomy

Exclusion Criteria

• acute cholecystitis, cholangitis, or pancreatitis
• no contraindication for the laparoscopic
• no other additional procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drain	drain positioned	drain positioned in the subhepatic space after laparoscopic cholecystectomy
Absence of drain	no drain	-
Absence of drain	drain not positioned	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Subhepatic Collection at Ultrasonographic Examination	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

Name	Time	Method
Number of Participants With Postoperative Complications	1 month

Trial Locations

Locations (1)

University of Rome "La Sapienza" - Polo Pontino; 🇮🇹 Terracina, Latina, Italy