Second-degree HemorrhoidsPhase 2SCLEROFOAMNCT03791775
Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease
A Phase 2 study testing Polidocanol foam (Atossisclerol® 3%) in people with Second-degree Hemorrhoids, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
Trial summary
Hemorrhoidal disease (HD) is one of the oldest and most common proctologic diseases that has been described with an estimated prevalence between 4.4% and 86%. Despite the proposal of three mechanisms that might underlie haemorrhoidal development - the varicose vein theory, the vascular hyperplasia theory and the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Second-degree Hemorrhoids
- What is being tested?
- Polidocanol foam (Atossisclerol® 3%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2019to 2 Jun 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 and below 75 years of age with a confirmed diagnosis of second-degree HD (proctological examination, proctoscopy and, if required, colonoscopy)
- Patients who report persistent perianal bleeding as a typical symptom of second-degree HD
- Informed consent from each patient must be obtained
- Participating centres will be asked to confirm that they have gained formal approval at their site
Who cannot join
- Previous anal surgical procedures
- Previous sclerotherapy or rubber band ligation in the last 12 months
- Positive pregnancy test
- Patients with inability to return for postoperative control visits, to sign the informed consent or to fill out the required clinical diary
- Breast-feeding
- Known allergy to polidocanol
Show all 19Show fewer
- Acute perianal thrombosis
- Anal fistula
- Anal fissure
- Proctitis
- Fecal incontinence
- Coagulation disorders
- Anticoagulant therapy
- Known HBV, HCV and HIV infection
- Acite Crohn's disease or Ulcerative colitis
- Diabetes mellitus I and II
- COPD
- Any kind of tumour
- Previous pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open-label, Single-arm Phase II Trial on the Efficacy and Safety of Sclerotherapy Using 3% Polidocanol Foam to Treat Second-degree Hemorrhoidal Disease
Hemorrhoidal disease (HD) is one of the oldest and most common proctologic diseases that has been described with an estimated prevalence between 4.4% and 86%. Despite the proposal of three mechanisms that might underlie haemorrhoidal development - the varicose vein theory, the vascular hyperplasia theory and the sliding anal-lining theory, the exact pathophysiology of symptomatic hemorrhoid disease is poorly understood.
HD seems to be the most common cause for rectal bleeding, or hematochezia, and the second most frequent cause for severe rectorrhagia after diverticulitis. The blood is bright red and coats the stool at the end of defection. Other symptoms include pain, mucous discharge, itching or the sensation of tissue prolapse.
Read more
The most widely accepted classification is the Goligher classification:
- Grade I: hemorrhoids bleed but do not prolapse out of the anal canal;
- Grade II: hemorrhoidal cushions prolapse outside of the anal canal on straining or during bowel movements, but reduce spontaneously;
- Grade III: hemorrhoidal cushions prolapse outside the anal canal on straining and require manual reduction;
- Grade IV: hemorrhoidal prolapse is irreducible even with manipulation
Read the detailed description
As reported by the guidelines of the Italian Society of Colorectal Surgery, in case of failure of conservative therapies the most common outpatient treatments for first- and second-degree Hemorrhoidal Disease (HD) are rubber band ligation and sclerotherapy.
Sclerotherapy causes an inflammatory reaction with local sclerosis of the submucosal tissue and a consequent fixation of the haemorrhoidal tissue to the underlying tissue. Moreover, the effect of sclerosing solutions is that of making vascular damage via producing endothelial injury.
A 100% improvement in bleeding was reported in patients with II and grade III hemorrhoids, and a complete resolution of the condition was described in 69% of non-selected patients, 52% in grade III and 88% in grade I. Resolution of prolapse was reported in 90-100% of patients affected by grade II hemorrhoids. Complications are rare but serious, and include impotence, irreversible necrotizing fasciitis and abdominal compartment syndrome [31-33]. In Germany, sclerotherapy with liquid agents is considered the first choice in treating grade I hemorrhoids. The only approved medical product by German authorities is polidocanol (Lauromacrogol 400 (INN), H3C-(CH2)11-(O-CH2-CH2)n∼9-OH), produced by Chemische Fabrik Kreussler \& Co. GmbH.
In Italy, this drug is known as Atossisclerol 3%. The polidocanol is a non-ionic detergent made up of a chain of hydrophilic polyethylene oxide mixed with aliphatic hydrophobic dodecyl alcohol and it is recommended for first- and second-degree HD. The effects of polidocanol are similar to those of phenol oil but less number of side effects.
Based on these experiences, Karl-Heinz Moser introduced the use of polidocanol foam in the treatment of grade I hemorrhoids. In 2013, the same author published the results of a randomized, controlled, single blind, multicentre trial on the efficacy and safety of sclerotherapy with polidocanol foam in comparison with liquid sclerosant agents in treating grade I hemorrhoids [28]. In the foam group success rate after one sclerotherapy session was 88%, while success rate among patients treated with liquid polidocanol was 69%. Furthermore, patients treated with foam were more satisfied than those treated with liquid polidocanol (99% vs. 84% p=0.009). Finally, the quantity of polidocanol injected in the foam group was significantly lower (p<0.001), as well as the number of sessions requested (p<0.001).
In summary, according to the authors, these results suggest that polidocanol foam can be used as the treatment of choice in grade I HD.
The aim of this study is to evaluate the efficacy and safety of sclerotherapy with 3% polidocanol foam (PF) on patients affected by second-degree HD.
- Conditions
- Second-degree Hemorrhoids
- Being tested
- Polidocanol foam (Atossisclerol® 3%)
- Keywords
- Hemorrhoids, Sclerotherapy, Polidocanol 3%, Non-surgical treatments
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polidocanol foam (Atossisclerol® 3%)Drug
The procedure will be performed in the Sims position or lithotomy position. A modified Blonde-Blanchard technique will be adopted, with the tangential injection of polidocanol foam into the submucosa of the apex of each hemorrhoidal pile, without exceeding three piles, and using a self-lighting open-ended anoscope and a 20-G needle in order to reduce bleeding
| Study group | Role | What they receive |
|---|---|---|
| Polidocanol 3% Foam | Experimental | Patients enrolled in the study, according to the inclusion and exclusion criteria, will undergo sclerotherapy performed with polidocanol foam (Atossisclerol® 3%, Chemische Fabrik Kreussler \& Co. GmbH, Wiesbaden, Germany). Receives: Drug: Polidocanol foam (Atossisclerol® 3%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate 1
To establish the success rate after one sclerotherapy session, in terms of complete resolution of bleeding episodes one week after the injection
Bleeding will be assessed using both the Hemorrhoidal Disease Symptoms Score and the Giamundo score.
Rørvik HD et al (2019) Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum; 62:333-342
Giamundo et al (2018) Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial. Tech Coloproctol; 25:635-643
Measured: 12 months follow-up
Secondary outcomes (5)
Success Rate 2
To establish the success rate in terms of partial or complete resolution of the symptoms
Symptoms will be assessed using the Hemorrhoidal Disease Symptom Score described by Rorvik HD
Measured: 12 months follow-up
Number of outpatient sessions
To evaluate the average number of outpatient sessions necessary for treatment success
Measured: 12 months follow-up
Rate of complications - adverse events
To establish the rate of complications
Measured: 6 months follow-up
Quality of Life
Short Health Scale HD
4 questions with 7-point Liker scale each (1 = very dissatisfied, 7 = very satisfied)
Minimum = 4
Maximum = 28
Measured: 12 months follow-up
To establish the average time required to reach autonomy
We considered autonomy as the return to normal activity: it includes also the return to work apart from cases of retired patients in which we considered it as the complete return to daily activities
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start2 Jan 2019
- Primary completion2 Jun 2019
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Second-degree HemorrhoidsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients enrolled in the study, according to the inclusion and exclusion criteria, will undergo sclerotherapy performed with polidocanol foam (Atossisclerol® 3%, Chemische Fabrik Kreussler \& Co. GmbH, Wiesbaden, Germany). The procedure will be performed in the Sims position or lithotomy position. A modified Blonde-Blanchard technique will be adopted, with the tangential injection of polidocanol foam into the submucosa of the apex of each hemorrhoidal pile, without exceeding three piles, and using a self-lighting open-ended anoscope and a 20-G needle in order to reduce bleeding
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Sponsor type
- Research network
- Collaborators
- SICCR - Gaetano Gallo
- Responsible party
- Sponsor
- Investigators
- Gaetano Gallo, MD, Principal investigator, Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro 88100, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791775
- Sponsor's protocol ID
- 274/2018
- Acronym
- SCLEROFOAM
- Status last verified
- Sep 2021
- First submitted
- 29 Dec 2018
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akerud L (1995) Sclerotherapy of haemorrhoids: a prospective randomised trial of polidocanol and phenol in oil. Coloproctology 17:73-86
Moser KH (2007) Evaluation of the efficacy and safety of polidocanol foam in the sclerotherapy of first degree bleeding haemorrhoids. Phlebol Rev (Przeglad Flebologiczny) 15:103-106
Blanchard CE (1928) Textbook of ambulant proctology p. 134. Medical Success Press, Youngstown Ohio
Gallo G, Sacco R, Sammarco G (2018) Epidemiology of Hemorrhoidal Disease. In: Hemorrhoids. Coloproctology (eds Ratto C, Parello A, Litta F), vol 2. Cham: Springer pp. 3-7
Thomson WH. The nature of haemorrhoids. Br J Surg. 1975 Jul;62(7):542-52. doi: 10.1002/bjs.1800620710.
PubMed 1174785Aigner F, Bodner G, Gruber H, Conrad F, Fritsch H, Margreiter R, Bonatti H. The vascular nature of hemorrhoids. J Gastrointest Surg. 2006 Jul-Aug;10(7):1044-50. doi: 10.1016/j.gassur.2005.12.004.
PubMed 16843876Burkitt DP. Varicose veins, deep vein thrombosis, and haemorrhoids: epidemiology and suggested aetiology. Br Med J. 1972 Jun 3;2(5813):556-61. doi: 10.1136/bmj.2.5813.556.
PubMed 5032782Gralnek IM, Ron-Tal Fisher O, Holub JL, Eisen GM. The role of colonoscopy in evaluating hematochezia: a population-based study in a large consortium of endoscopy practices. Gastrointest Endosc. 2013 Mar;77(3):410-8. doi: 10.1016/j.gie.2012.10.025. Epub 2013 Jan 5.
PubMed 23294756Nikpour S, Ali Asgari A. Colonoscopic evaluation of minimal rectal bleeding in average-risk patients for colorectal cancer. World J Gastroenterol. 2008 Nov 14;14(42):6536-40. doi: 10.3748/wjg.14.6536.
PubMed 19030208Wong RF, Khosla R, Moore JH, Kuwada SK. Consider colonoscopy for young patients with hematochezia. J Fam Pract. 2004 Nov;53(11):879-84.
PubMed 15527724Mehanna D, Platell C. Investigating chronic, bright red, rectal bleeding. ANZ J Surg. 2001 Dec;71(12):720-2. doi: 10.1046/j.1445-1433.2001.02277.x.
PubMed 11906386Gayer C, Chino A, Lucas C, Tokioka S, Yamasaki T, Edelman DA, Sugawa C. Acute lower gastrointestinal bleeding in 1,112 patients admitted to an urban emergency medical center. Surgery. 2009 Oct;146(4):600-6; discussion 606-7. doi: 10.1016/j.surg.2009.06.055.
PubMed 19789018Newman J, Fitzgerald JE, Gupta S, von Roon AC, Sigurdsson HH, Allen-Mersh TG. Outcome predictors in acute surgical admissions for lower gastrointestinal bleeding. Colorectal Dis. 2012 Aug;14(8):1020-6. doi: 10.1111/j.1463-1318.2011.02824.x.
PubMed 21910819Goligher JC. Cryosurgery for hemorrhoids. Dis Colon Rectum. 1976 Apr;19(3):213-8. doi: 10.1007/BF02590905. No abstract available.
PubMed 1269347Trompetto M, Clerico G, Cocorullo GF, Giordano P, Marino F, Martellucci J, Milito G, Mistrangelo M, Ratto C. Erratum to: Evaluation and management of hemorrhoids: Italian society of colorectal surgery (SICCR) consensus statement. Tech Coloproctol. 2016 Mar;20(3):201. doi: 10.1007/s10151-015-1416-0. No abstract available.
PubMed 26728606
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Single-arm Phase II Trial on the Efficacy and Safety of Sclerotherapy Using 3% Polidocanol Foam to Treat Second-degree Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT03791775
- Acronym / sponsor ID
- SCLEROFOAM / 274/2018
- Conditions
- Second-degree Hemorrhoids
- Keywords
- Hemorrhoids, Sclerotherapy, Polidocanol 3%, Non-surgical treatments
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettaleResearch network
- Collaborators
- SICCR - Gaetano Gallo
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 3 Jan 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.
Hemorrhoidal disease (HD) is one of the oldest and most common proctologic diseases that has been described with an estimated prevalence between 4.4% and 86%. Despite the proposal of three mechanisms that might underlie haemorrhoidal development - the varicose vein theory, the vascular hyperplasia theory and the sliding anal-lining theory, the exact pathophysiology of symptomatic hemorrhoid disease is poorly understood.
HD seems to be the most common cause for rectal bleeding, or hematochezia, and the second most frequent cause for severe rectorrhagia after diverticulitis. The blood is bright red and coats the stool at the end of defection. Other symptoms include pain, mucous discharge, itching or the sensation of tissue prolapse.
The most widely accepted classification is the Goligher classification:
- Grade I: hemorrhoids bleed but do not prolapse out of the anal canal;
- Grade II: hemorrhoidal cushions prolapse outside of the anal canal on straining or during bowel movements, but reduce spontaneously;
- Grade III: hemorrhoidal cushions prolapse outside the anal canal on straining and require manual reduction;
- Grade IV: hemorrhoidal prolapse is irreducible even with manipulation
Detailed description
As reported by the guidelines of the Italian Society of Colorectal Surgery, in case of failure of conservative therapies the most common outpatient treatments for first- and second-degree Hemorrhoidal Disease (HD) are rubber band ligation and sclerotherapy.
Sclerotherapy causes an inflammatory reaction with local sclerosis of the submucosal tissue and a consequent fixation of the haemorrhoidal tissue to the underlying tissue. Moreover, the effect of sclerosing solutions is that of making vascular damage via producing endothelial injury.
A 100% improvement in bleeding was reported in patients with II and grade III hemorrhoids, and a complete resolution of the condition was described in 69% of non-selected patients, 52% in grade III and 88% in grade I. Resolution of prolapse was reported in 90-100% of patients affected by grade II hemorrhoids. Complications are rare but serious, and include impotence, irreversible necrotizing fasciitis and abdominal compartment syndrome [31-33]. In Germany, sclerotherapy with liquid agents is considered the first choice in treating grade I hemorrhoids. The only approved medical product by German authorities is polidocanol (Lauromacrogol 400 (INN), H3C-(CH2)11-(O-CH2-CH2)n∼9-OH), produced by Chemische Fabrik Kreussler \& Co. GmbH.
In Italy, this drug is known as Atossisclerol 3%. The polidocanol is a non-ionic detergent made up of a chain of hydrophilic polyethylene oxide mixed with aliphatic hydrophobic dodecyl alcohol and it is recommended for first- and second-degree HD. The effects of polidocanol are similar to those of phenol oil but less number of side effects.
Based on these experiences, Karl-Heinz Moser introduced the use of polidocanol foam in the treatment of grade I hemorrhoids. In 2013, the same author published the results of a randomized, controlled, single blind, multicentre trial on the efficacy and safety of sclerotherapy with polidocanol foam in comparison with liquid sclerosant agents in treating grade I hemorrhoids [28]. In the foam group success rate after one sclerotherapy session was 88%, while success rate among patients treated with liquid polidocanol was 69%. Furthermore, patients treated with foam were more satisfied than those treated with liquid polidocanol (99% vs. 84% p=0.009). Finally, the quantity of polidocanol injected in the foam group was significantly lower (p<0.001), as well as the number of sessions requested (p<0.001).
In summary, according to the authors, these results suggest that polidocanol foam can be used as the treatment of choice in grade I HD.
The aim of this study is to evaluate the efficacy and safety of sclerotherapy with 3% polidocanol foam (PF) on patients affected by second-degree HD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients enrolled in the study, according to the inclusion and exclusion criteria, will undergo sclerotherapy performed with polidocanol foam (Atossisclerol® 3%, Chemische Fabrik Kreussler \& Co. GmbH, Wiesbaden, Germany). The procedure will be performed in the Sims position or lithotomy position. A modified Blonde-Blanchard technique will be adopted, with the tangential injection of polidocanol foam into the submucosa of the apex of each hemorrhoidal pile, without exceeding three piles, and using a self-lighting open-ended anoscope and a 20-G needle in order to reduce bleeding
| Arm | Type | Receives |
|---|---|---|
| Polidocanol 3% Foam | Experimental | Drug: Polidocanol foam (Atossisclerol® 3%)Patients enrolled in the study, according to the inclusion and exclusion criteria, will undergo sclerotherapy performed with polidocanol foam (Atossisclerol® 3%, Chemische Fabrik Kreussler \& Co. GmbH, Wiesbaden, Germany). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients above 18 and below 75 years of age with a confirmed diagnosis of second-degree HD (proctological examination, proctoscopy and, if required, colonoscopy)
- Patients who report persistent perianal bleeding as a typical symptom of second-degree HD
- Informed consent from each patient must be obtained
- Participating centres will be asked to confirm that they have gained formal approval at their site
Key exclusion criteria (19 listed)
- Previous anal surgical procedures
- Previous sclerotherapy or rubber band ligation in the last 12 months
- Positive pregnancy test
- Patients with inability to return for postoperative control visits, to sign the informed consent or to fill out the required clinical diary
- Breast-feeding
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 |
|---|---|---|
| Polidocanol foam (Atossisclerol® 3%)The procedure will be performed in the Sims position or lithotomy position. A modified Blonde-Blanchard technique will be adopted, with the tangential injection of polidocanol foam into the submucosa of the apex of each hemorrhoidal pile, without exceeding three piles, and using a self-lighting open-ended anoscope and a 20-G needle in order to reduce bleeding | Drug | Polidocanol 3% Foam |
Primary outcome
Success Rate 1
Time frame: 12 months follow-up
To establish the success rate after one sclerotherapy session, in terms of complete resolution of bleeding episodes one week after the injection Bleeding will be assessed using both the Hemorrhoidal Disease Symptoms Score and the Giamundo score. Rørvik HD et al (2019) Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum; 62:333-342 Giamundo et al (2018) Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial. Tech Coloproctol; 25:635-643
5 secondary outcomes
Success Rate 2
Time frame: 12 months follow-up
Number of outpatient sessions
Time frame: 12 months follow-up
Rate of complications - adverse events
Time frame: 6 months follow-up
Quality of Life
Time frame: 12 months follow-up
To establish the average time required to reach autonomy
Time frame: 12 months follow-up
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 17 Sep 2021.
- BackgroundAkerud L (1995) Sclerotherapy of haemorrhoids: a prospective randomised trial of polidocanol and phenol in oil. Coloproctology 17:73-86
- BackgroundMoser KH (2007) Evaluation of the efficacy and safety of polidocanol foam in the sclerotherapy of first degree bleeding haemorrhoids. Phlebol Rev (Przeglad Flebologiczny) 15:103-106
- BackgroundBlanchard CE (1928) Textbook of ambulant proctology p. 134. Medical Success Press, Youngstown Ohio
- BackgroundGallo G, Sacco R, Sammarco G (2018) Epidemiology of Hemorrhoidal Disease. In: Hemorrhoids. Coloproctology (eds Ratto C, Parello A, Litta F), vol 2. Cham: Springer pp. 3-7
- Results publication: PubMed 1174785Thomson WH. The nature of haemorrhoids. Br J Surg. 1975 Jul;62(7):542-52. doi: 10.1002/bjs.1800620710.
- Results publication: PubMed 16843876Aigner F, Bodner G, Gruber H, Conrad F, Fritsch H, Margreiter R, Bonatti H. The vascular nature of hemorrhoids. J Gastrointest Surg. 2006 Jul-Aug;10(7):1044-50. doi: 10.1016/j.gassur.2005.12.004.
- Results publication: PubMed 5032782Burkitt DP. Varicose veins, deep vein thrombosis, and haemorrhoids: epidemiology and suggested aetiology. Br Med J. 1972 Jun 3;2(5813):556-61. doi: 10.1136/bmj.2.5813.556.
- Results publication: PubMed 23294756Gralnek IM, Ron-Tal Fisher O, Holub JL, Eisen GM. The role of colonoscopy in evaluating hematochezia: a population-based study in a large consortium of endoscopy practices. Gastrointest Endosc. 2013 Mar;77(3):410-8. doi: 10.1016/j.gie.2012.10.025. Epub 2013 Jan 5.
- Results publication: PubMed 19030208Nikpour S, Ali Asgari A. Colonoscopic evaluation of minimal rectal bleeding in average-risk patients for colorectal cancer. World J Gastroenterol. 2008 Nov 14;14(42):6536-40. doi: 10.3748/wjg.14.6536.
- Results publication: PubMed 15527724Wong RF, Khosla R, Moore JH, Kuwada SK. Consider colonoscopy for young patients with hematochezia. J Fam Pract. 2004 Nov;53(11):879-84.
- Results publication: PubMed 11906386Mehanna D, Platell C. Investigating chronic, bright red, rectal bleeding. ANZ J Surg. 2001 Dec;71(12):720-2. doi: 10.1046/j.1445-1433.2001.02277.x.
- Results publication: PubMed 19789018Gayer C, Chino A, Lucas C, Tokioka S, Yamasaki T, Edelman DA, Sugawa C. Acute lower gastrointestinal bleeding in 1,112 patients admitted to an urban emergency medical center. Surgery. 2009 Oct;146(4):600-6; discussion 606-7. doi: 10.1016/j.surg.2009.06.055.
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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.
Gaetano Gallo, MD principal investigator
Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro 88100, Italy
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 Polidocanol foam (Atossisclerol® 3%) in people with Second-degree Hemorrhoids, run by Societa Italiana di Chirurgia ColoRettale 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 4 inclusion and 19 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 17 Sep 2021. 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 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?
Success Rate 1 (time frame: 12 months follow-up). 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 NCT03791775, which also lists 47 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 17 Sep 2021.