Postoperative PainPhase 3NCT01378819
3-midline-ports Cholecystectomy
A Phase 3 study testing 3-midline-ports laparoscopic cholecystectomy in people with Postoperative Pain, run by Universidad Miguel Hernandez de Elche.
Trial summary
The 3-midline-ports technique is a safety approach and associates lower postoperative pain, when compared with the standard "French" technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- 3-midline-ports laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective cholecystectomy for symptomatic gallstones.
Who cannot join
- Diagnosis of acute cholecystitis
About this study
Official title: Three Ports Placed in the Line Alba of the Abdomen (3-midline-ports Technique): an Alternative Approach for Laparoscopic Cholecystectomy
The 3-midline-ports technique is a safety approach and associates lower postoperative pain, when compared with the standard "French" technique.
Read the detailed description
The patients will be randomized into 2 groups: those patients undergoing laparoscopic cholecystectomy following the "French" technique (Group 1) and those ones undergoing the 3-midline-ports approach (Group 2).
- Conditions
- Postoperative Pain
- Being tested
- 3-midline-ports laparoscopic cholecystectomy
- Keywords
- laparoscopic cholecystectomy, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-midline-ports laparoscopic cholecystectomyProcedure or surgery
The laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.
3-midline-ports laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The postoperative pain will be investigated 24 hours after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378819
- Sponsor's protocol ID
- UMH
- Status last verified
- Feb 2010
- First submitted
- 20 Jun 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Ports Placed in the Line Alba of the Abdomen (3-midline-ports Technique): an Alternative Approach for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01378819
- Acronym / sponsor ID
- UMH
- Conditions
- Postoperative Pain
- Keywords
- laparoscopic cholecystectomy, Postoperative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 3-midline-ports technique is a safety approach and associates lower postoperative pain, when compared with the standard "French" technique.
Detailed description
The patients will be randomized into 2 groups: those patients undergoing laparoscopic cholecystectomy following the "French" technique (Group 1) and those ones undergoing the 3-midline-ports approach (Group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective cholecystectomy for symptomatic gallstones.
Key exclusion criteria (1 listed)
- Diagnosis of acute cholecystitis
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 |
|---|---|---|
| 3-midline-ports laparoscopic cholecystectomyThe laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba. | Procedure or surgery | – |
| 3-midline-ports laparoscopic cholecystectomyLaparoscopic cholecystectomy will be performed through 3 ports placed in the line alba. | Procedure or surgery | – |
Primary outcome
Postoperative pain
Time frame: 24 hours
The postoperative pain will be investigated 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3-midline-ports laparoscopic cholecystectomy in people with Postoperative Pain, run by Universidad Miguel Hernandez de Elche.
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 1 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 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2011.