Pain, PostoperativePhase 2NCT04057079
Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy
A Phase 2 study testing Anugel, Hydrogel sponge and Gelatine Sponge in people with Pain, Postoperative, run by Deep Life Medical Ltd at 1 site in Turkey (Türkiye).
Trial summary
Post-operational pain is the most common problem relating to haemorrhoidectomy. This study aims to evaluate the postoperative effects of Anugel a hydrogel impregnated multi component sponge vs gelatine sponge comparatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Anugel, Hydrogel sponge and Gelatine Sponge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2014to 1 Feb 2019
- Phase
- Phase 2
- 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
- Haemorrhoid (grade 3-4)
Who cannot join
- Repeating cases, additional (non haemorrhoid related) complications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Memorial Sisli Hospital
Istanbul, Sisli, 34385
About this study
Official title: Anugel vs Gelatine Sponge Clinical Trial
Post-operational pain is the most common problem relating to haemorrhoidectomy. This study aims to evaluate the postoperative effects of Anugel a hydrogel impregnated multi component sponge vs gelatine sponge comparatively.
Read the detailed description
The patients were placed in the lithotomy position. Haemorrhoids (piles) were later located through exploration. The piles were dissected using ligasure. After completing the dissection, bleeding was controlled and either Anugel or the gelatine sponge (SpongostanTM) is inserted in to the rectum as determined by patient allocation.
The patients were monitored post operation and 5 days following the surgery. Pain was measured using the VAS scale and use of pain medication was monitored.
- Conditions
- Pain, Postoperative
- Being tested
- Anugel, Hydrogel sponge, Gelatine Sponge
- Keywords
- Hemoroidectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anugel, Hydrogel spongeCombination product
A calibrated sponge impregnated with hydrogel is inserted to the rectum post hemoroidectomy.
Gelatine SpongeCombination product
A gelatine sponge is inserted in to the rectum pos hemoroidectomy.
| Study group | Role | What they receive |
|---|---|---|
| Anugel | Experimental | In this arm, after the surgery a hydrogel impregnated sponge will be placed in the rectum.
The patient is evaluated after the operation and the following day when the sponge is removed.
A hydrogel impregnated foam pad is applied on the surface of the wound the following 5 days.
The patient is evaluated on post op, on day 1 (usually before discharge) and day 5
The pain of the patients are evaluated according to the VAS scale and the use of analgesics and opioids is monitored. Receives: Combination Product: Anugel, Hydrogel sponge |
| Sponge | Active comparator | Currently used treatment method i.e. insertion of gelatine sponge in to the rectum post operation.
The patient is evaluated on post op, on day 1 (usually before discharge) and day 5
The pain of the patients are evaluated according to the VAS scale and the use of analgesics and opioids is monitored. Receives: Combination Product: Gelatine Sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Amount of pain patients feel post operation. Post surgery and on days 1 and 5 the pain felt by the patient will be measured according to the VAS scale, either in hospital or during hospital visit.
Measured: 5 days
Secondary outcomes (1)
Use of analgesics
The frequency and dose of analgesics for pain management is monitored post operation, on day 1 and day 5
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start4 Apr 2014
- Primary completion9 Jul 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Research staff used a computer-based tool to allocate the ligasure haemorrhoidectomy patients randomly to either Group 1 (n=56) who received standard anal gelatine sponge (SpongostanTM) or Group 2 (n-54) to a layered hydrogel sponge (AnugelTM) following surgery. Encryption concealed the allocation until the patient's details had been logged.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deep Life Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057079
- Sponsor's protocol ID
- Anugel20170420
- Status last verified
- Aug 2019
- First submitted
- 1 May 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anugel vs Gelatine Sponge Clinical Trial
- ClinicalTrials.gov ID
- NCT04057079
- Acronym / sponsor ID
- Anugel20170420
- Conditions
- Pain, Postoperative
- Keywords
- Hemoroidectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Deep Life Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2014 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 15 Aug 2019 (actual)
- 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.
Post-operational pain is the most common problem relating to haemorrhoidectomy. This study aims to evaluate the postoperative effects of Anugel a hydrogel impregnated multi component sponge vs gelatine sponge comparatively.
Detailed description
The patients were placed in the lithotomy position. Haemorrhoids (piles) were later located through exploration. The piles were dissected using ligasure. After completing the dissection, bleeding was controlled and either Anugel or the gelatine sponge (SpongostanTM) is inserted in to the rectum as determined by patient allocation.
The patients were monitored post operation and 5 days following the surgery. Pain was measured using the VAS scale and use of pain medication was monitored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Research staff used a computer-based tool to allocate the ligasure haemorrhoidectomy patients randomly to either Group 1 (n=56) who received standard anal gelatine sponge (SpongostanTM) or Group 2 (n-54) to a layered hydrogel sponge (AnugelTM) following surgery. Encryption concealed the allocation until the patient's details had been logged.
| Arm | Type | Receives |
|---|---|---|
| Anugel | Experimental | Combination Product: Anugel, Hydrogel spongeIn this arm, after the surgery a hydrogel impregnated sponge will be placed in the rectum. The patient is evaluated after the operation and the following day when the sponge is removed. A hydrogel impregnated foam pad is applied on the surface of the wound the following 5 days. The patient is evaluated on post op, on day 1 (usually before discharge) and day 5 The pain of the patients are evaluated according to the VAS scale and the use of analgesics and opioids is monitored. |
| Sponge | Active comparator | Combination Product: Gelatine SpongeCurrently used treatment method i.e. insertion of gelatine sponge in to the rectum post operation. The patient is evaluated on post op, on day 1 (usually before discharge) and day 5 The pain of the patients are evaluated according to the VAS scale and the use of analgesics and opioids is monitored. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Haemorrhoid (grade 3-4)
Key exclusion criteria (1 listed)
- Repeating cases, additional (non haemorrhoid related) complications
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 |
|---|---|---|
| Anugel, Hydrogel spongeA calibrated sponge impregnated with hydrogel is inserted to the rectum post hemoroidectomy. | Combination product | Anugel |
| Gelatine SpongeA gelatine sponge is inserted in to the rectum pos hemoroidectomy. | Combination product | Sponge |
Primary outcome
Pain Reduction
Time frame: 5 days
Amount of pain patients feel post operation. Post surgery and on days 1 and 5 the pain felt by the patient will be measured according to the VAS scale, either in hospital or during hospital visit.
1 secondary outcome
Use of analgesics
Time frame: 5 days
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 15 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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 study testing Anugel, Hydrogel sponge and Gelatine Sponge in people with Pain, Postoperative, run by Deep Life Medical Ltd at 1 site in Turkey (Türkiye).
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 15 Aug 2019. 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 Turkey (Türkiye). 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pain Reduction (time frame: 5 days). 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 15 Aug 2019.