Postoperative AdhesionPhase 4NCT01187680
Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy
A Phase 4 study testing Spraygel in people with Postoperative Adhesion and Peritoneal Adhesion, Nos, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Adhesion, Peritoneal Adhesion, Nos
- What is being tested?
- Spraygel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2002to Jul 2009
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- >18 years
- Undergoing gynecologic laparoscopy
Who cannot join
- Suspected malignancy
- Incomplete adhesiolysis during initial laparoscopy
- Pregnancy
- Lactating
- Stage IV endometriosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polyethylene Glycol Adhesion Barrier Reduces Adhesions After Gynecologic Laparoscopy; a Prospective Randomized Controlled Pilot Study
The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.
- Conditions
- Postoperative Adhesion, Peritoneal Adhesion, Nos
- Being tested
- Spraygel, Control
- Keywords
- Tissue adhesions, Laparoscopy
- Medical subject headings
- Pyloric Stenosis, Hypertrophic, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpraygelDevice
ControlDevice
Good surgical technique, no adhesion barrier
| Study group | Role | What they receive |
|---|---|---|
| Spraygel | Experimental | Not described Receives: Device: Spraygel |
| Control | Active comparator | Not described Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful adhesion prevention
Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.
Secondary outcomes (2)
LABS adhesion score
Adhesion sites
Reduction in the number of sites covered with adhesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startOct 2002
- Primary completionApr 2004
- Study completionJul 2009
Why it stopped: Financial and organisational reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AdhesionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187680
- Sponsor's protocol ID
- RU-RTB-0002
- Status last verified
- Aug 2010
- First submitted
- 19 Jul 2010
- Last updated
- 29 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyethylene Glycol Adhesion Barrier Reduces Adhesions After Gynecologic Laparoscopy; a Prospective Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01187680
- Acronym / sponsor ID
- RU-RTB-0002
- Conditions
- Postoperative Adhesion, Peritoneal Adhesion, Nos
- Keywords
- Tissue adhesions, Laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial and organisational reasons
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis
- Study start
- Oct 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 Aug 2010 (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 purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spraygel | Experimental | Device: Spraygel |
| Control | Active comparator | Device: Control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- >18 years
- Undergoing gynecologic laparoscopy
Key exclusion criteria (5 listed)
- Suspected malignancy
- Incomplete adhesiolysis during initial laparoscopy
- Pregnancy
- Lactating
- Stage IV endometriosis
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 |
|---|---|---|
| Spraygel | Device | Spraygel |
| ControlGood surgical technique, no adhesion barrier | Device | Control |
Primary outcome
successful adhesion prevention
Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.
2 secondary outcomes
LABS adhesion score
Adhesion sites
Results and safety
The study was stopped early (reason given: Financial and organisational reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2010.
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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 4 study testing Spraygel in people with Postoperative Adhesion and Peritoneal Adhesion, Nos, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Dec 2010. 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 Netherlands. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Financial and organisational reasons). Results are not available in the source record.
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?
successful adhesion prevention. 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 29 Dec 2010; AzTrials last refreshed its copy on 6 Nov 2026.