Postoperative PainPhase 2/3NCT01418807
Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy
A Phase 2/3 study testing TRANSVAGINAL SPECIMEN EXTRACTION and TRANSUMBILICAL SPECIMEN EXTRACTION in people with Postoperative Pain and Patients Satisfaction, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
We hypothesise that pain at minilaparoscopy for gynecologic disease is reduced when transvaginal rather than transumbilical specimen extraction is accomplished. This would be due to the avoidance of a 10-mm port in the umbilicus. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postoperative Pain, Patients Satisfaction, Intraoperative Complications
- What is being tested?
- TRANSVAGINAL SPECIMEN EXTRACTION and TRANSUMBILICAL SPECIMEN EXTRACTION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 2/3
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adnexal Mass
- Benign Gynecologic Condition
- Laparoscopicb Surgery
Who cannot join
- Obliteration Of The Douglas Pouch
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Obstetrics and Gynecology Universita' Dell'Insubria
Varese, 21100
About this study
We hypothesise that pain at minilaparoscopy for gynecologic disease is reduced when transvaginal rather than transumbilical specimen extraction is accomplished. This would be due to the avoidance of a 10-mm port in the umbilicus. Visual analogue scale score of post-operative pain will be obtained and patients satisfaction will be asked at the 2-month postoperative visit.
- Conditions
- Postoperative Pain, Patients Satisfaction, Intraoperative Complications, Postoperative Complications
- Being tested
- TRANSVAGINAL SPECIMEN EXTRACTION, TRANSUMBILICAL SPECIMEN EXTRACTION
- Medical subject headings
- Pain, Postoperative, Intraoperative Complications, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRANSVAGINAL SPECIMEN EXTRACTIONProcedure or surgery
Transvaginal specimen retrieval following posterior colpotomy
TRANSUMBILICAL SPECIMEN EXTRACTIONProcedure or surgery
Transumbilical specimen retrieval following enlargement of the umbilical port
| Study group | Role | What they receive |
|---|---|---|
| TRANSVAGINAL EXTRACTION | Experimental | Not described Receives: Procedure: TRANSVAGINAL SPECIMEN EXTRACTION |
| TRANSUMBILICAL EXTRACTION | Active comparator | Not described Receives: Procedure: TRANSUMBILICAL SPECIMEN EXTRACTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Ghezzi, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418807
- Sponsor's protocol ID
- mini-LPS Specimen extraction
- Status last verified
- Feb 2012
- First submitted
- 16 Aug 2011
- Last updated
- 24 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy
- ClinicalTrials.gov ID
- NCT01418807
- Acronym / sponsor ID
- mini-LPS Specimen extraction
- Conditions
- Postoperative Pain, Patients Satisfaction, Intraoperative Complications, Postoperative Complications
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Aug 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.
We hypothesise that pain at minilaparoscopy for gynecologic disease is reduced when transvaginal rather than transumbilical specimen extraction is accomplished. This would be due to the avoidance of a 10-mm port in the umbilicus. Visual analogue scale score of post-operative pain will be obtained and patients satisfaction will be asked at the 2-month postoperative visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRANSVAGINAL EXTRACTION | Experimental | Procedure: TRANSVAGINAL SPECIMEN EXTRACTION |
| TRANSUMBILICAL EXTRACTION | Active comparator | Procedure: TRANSUMBILICAL SPECIMEN EXTRACTION |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adnexal Mass
- Benign Gynecologic Condition
- Laparoscopicb Surgery
Key exclusion criteria (1 listed)
- Obliteration Of The Douglas Pouch
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 |
|---|---|---|
| TRANSVAGINAL SPECIMEN EXTRACTIONTransvaginal specimen retrieval following posterior colpotomy | Procedure or surgery | TRANSVAGINAL EXTRACTION |
| TRANSUMBILICAL SPECIMEN EXTRACTIONTransumbilical specimen retrieval following enlargement of the umbilical port | Procedure or surgery | TRANSUMBILICAL EXTRACTION |
Primary outcome
Postoperative Pain
Time frame: 3 months
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 24 Feb 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TRANSVAGINAL SPECIMEN EXTRACTION and TRANSUMBILICAL SPECIMEN EXTRACTION in people with Postoperative Pain and Patients Satisfaction, run by Università degli Studi dell'Insubria 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 3 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 24 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: 3 months). 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 24 Feb 2012.