CholelithiasisNCT00986544
Drain After Elective Laparoscopic Cholecystectomy
A study testing no drain, drain positioned and drain not positioned in people with Cholelithiasis, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The trial aims to assess the value of drains in elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- no drain, drain positioned and drain not positioned
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective laparoscopic cholecystectomy
Who cannot join
- acute cholecystitis, cholangitis, or pancreatitis
- no contraindication for the laparoscopic
- no other additional procedure
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Rome "La Sapienza" - Polo Pontino
Terracina, Latina, 04019
About this study
Official title: Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial
The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.
Read the 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
- Conditions
- Cholelithiasis
- Being tested
- no drain, drain positioned, drain not positioned
- Keywords
- Laparoscopy, cholecystectomy, drainage
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no drainProcedure or surgery
drain positioned on the skin
drain positionedProcedure or surgery
drain positioned in the subhepatic space
drain not positionedProcedure or surgery
Drain positioned in the abdominal wall
| Study group | Role | What they receive |
|---|---|---|
| Absence of drain | Sham comparator | Not described Receives: Procedure: no drain; Procedure: drain not positioned |
| Drain | Active comparator | drain positioned in the subhepatic space after laparoscopic cholecystectomy Receives: Procedure: drain positioned |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first postoperative day
Secondary outcomes (1)
Number of Participants With Postoperative Complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erasmo Spaziani, University of Roma La Sapienza
- Investigators
- Erasmo Spaziani, PhD, Study director, University of Rome "La Sapienza"- Polo Pontino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986544
- Sponsor's protocol ID
- Pic63
- Status last verified
- Feb 2012
- First submitted
- 29 Sep 2009
- Last updated
- 23 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17943873Tzovaras 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.
PubMed 18926516
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drain After Elective Laparoscopic Cholecystectomy. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00986544
- Acronym / sponsor ID
- Pic63
- Conditions
- Cholelithiasis
- Keywords
- Laparoscopy, cholecystectomy, drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Posted 23 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absence of drain | Sham comparator | Procedure: no drain, Procedure: drain not positioned |
| Drain | Active comparator | Procedure: drain positioneddrain positioned in the subhepatic space after laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective laparoscopic cholecystectomy
Key exclusion criteria (3 listed)
- acute cholecystitis, cholangitis, or pancreatitis
- no contraindication for the laparoscopic
- no other additional procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no draindrain positioned on the skin | Procedure or surgery | Absence of drain |
| drain positioneddrain positioned in the subhepatic space | Procedure or surgery | Drain |
| drain not positionedDrain positioned in the abdominal wall | Procedure or surgery | Absence of drain |
Primary outcome
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.
1 secondary outcome
Number of Participants With Postoperative Complications
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17943873Gurusamy 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.
- Background: PubMed 18926516Tzovaras 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.
Related trials for Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
Intravenous Anesthesia, Cholelithiasis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erasmo Spaziani, PhD study director
University of Rome "La Sapienza"- Polo Pontino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no drain, drain positioned and drain not positioned in people with Cholelithiasis, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Subhepatic Collection at Ultrasonographic Examination (time frame: first postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00986544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2012.