Drain After Elective Laparoscopic Cholecystectomy

NCT ID: NCT00986544

Last Updated: 2012-03-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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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

Conditions

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Cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Absence of drain

Group Type SHAM_COMPARATOR

no drain

Intervention Type PROCEDURE

drain positioned on the skin

drain not positioned

Intervention Type PROCEDURE

Drain positioned in the abdominal wall

Drain

drain positioned in the subhepatic space after laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

drain positioned

Intervention Type PROCEDURE

drain positioned in the subhepatic space

Interventions

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no drain

drain positioned on the skin

Intervention Type PROCEDURE

drain positioned

drain positioned in the subhepatic space

Intervention Type PROCEDURE

drain not positioned

Drain positioned in the abdominal wall

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* elective laparoscopic cholecystectomy

Exclusion Criteria

* acute cholecystitis, cholangitis, or pancreatitis
* no contraindication for the laparoscopic
* no other additional procedure
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Erasmo Spaziani

MD; PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erasmo Spaziani, PhD

Role: STUDY_DIRECTOR

University of Rome "La Sapienza"- Polo Pontino

Locations

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University of Rome "La Sapienza" - Polo Pontino

Terracina, Latina, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 17943873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18926516 (View on PubMed)

Other Identifiers

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Pic63

Identifier Type: -

Identifier Source: org_study_id

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