NCT00986544

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 23, 2012

Completed
Last Updated

March 23, 2012

Status Verified

February 1, 2012

Enrollment Period

1.2 years

First QC Date

September 29, 2009

Results QC Date

January 16, 2012

Last Update Submit

February 18, 2012

Conditions

Cholelithiasis

Keywords

Laparoscopycholecystectomydrainage

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of Participants With Postoperative Complications

    1 month

Study Arms (2)

Absence of drain

SHAM COMPARATOR
Procedure: no drainProcedure: drain not positioned

Drain

ACTIVE COMPARATOR

drain positioned in the subhepatic space after laparoscopic cholecystectomy

Procedure: drain positioned

Interventions

no drainPROCEDURE

drain positioned on the skin

Absence of drain
drain positionedPROCEDURE

drain positioned in the subhepatic space

Drain
drain not positionedPROCEDURE

Drain positioned in the abdominal wall

Absence of drain

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective laparoscopic cholecystectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rome "La Sapienza" - Polo Pontino

Terracina, Latina, 04019, Italy

Location

Related 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. doi: 10.1002/14651858.CD006004.pub3.

    PMID: 17943873BACKGROUND

  • 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.

    PMID: 18926516BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Results Point of Contact

Title
Marcello Picchio
Organization
Department of Surgery, Hospital "P. Colombo", Via Orti Ginnetti 7, 00049 Velletri (Rome), Italy
marcellopicchio@libero.it
+39696102228

Study Officials

  • Erasmo Spaziani, PhD

    University of Rome "La Sapienza"- Polo Pontino

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

December 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 23, 2012

Results First Posted

March 23, 2012

Record last verified: 2012-02

Locations

IT(1)