Lower Gastrointestinal TractCASPeRNCT02846285
Causes of Low Digestive Bleeding in Proctology
An observational study of Lower Gastrointestinal Tract and Colorectal Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The various causes of bleeding Proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. Investigators wanted to evaluate this data as part of a specialized consultation. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Lower Gastrointestinal Tract, Colorectal Surgery, Proctology
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jul 2014
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Exploration was offered to all patients over 45 years and / or when indicated by the pathological context
Who may be able to join
- All patients with proctological context
Who cannot join
- Patients refusing to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The various causes of bleeding Proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. Investigators wanted to evaluate this data as part of a specialized consultation. Investigators have prospectively collected the causes of gastrointestinal bleeding down the patients seen two of us in specialized proctology center. A clinical examination including an inspection, palpation and feel, and a anoscopy (when possible) were made during the consultation. Local levies referred (s) histological and / or infection were also carried out if necessary. When she had not been made, a colonic exploration was offered to all patients over 45 years and / or when indicated by the pathological context. When there were several possible causes, the clinician holding one that seemed to be the main. Patients consulting within four months postoperatively a proctology action were not included. The study period extended from September 2013 to July 2014 inclusive. The collection of anonymous data.
Read the detailed description
The various causes of bleeding Proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. Investigators wanted to evaluate this data as part of a specialized consultation. Investigators have prospectively collected the causes of gastrointestinal bleeding down the patients seen two of us in specialized proctology center. A clinical examination including an inspection, palpation and feel, and a anoscopy (when possible) were made during the consultation. Local levies referred (s) histological and / or infection were also carried out if necessary. When she had not been made, a colonic exploration was offered to all patients over 45 years and / or when indicated by the pathological context. When there were several possible causes, the clinician holding one that seemed to be the main. Patients consulting within four months postoperatively a proctology action were not included. The study period extended from September 2013 to July 2014 inclusive. The collection of anonymous data.
- Conditions
- Lower Gastrointestinal Tract, Colorectal Surgery, Proctology
- Being tested
- No intervention
- Keywords
- Bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of causes and determine the origin of down gastrointestinal bleedings
Determine the origine of gastrointestinal bleedings from the below:
- Internal hemorrhoidal pathology
- Anal Fissure
- Perianal Crohn lesions
- Cryto-glandular Anal fistula
- Thrombosis external hemorrhoidal
- Anal condylomata and / or perianal
- Syndrome solitary rectal ulcer without prolapse externalized
- Ano-radiation proctitis
- Anal dermatitis and / or perianal
- Complete Rectal prolapse externalized
- Ulcerative colitis Recto
- other
Measured: Within 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Gastrointestinal TractStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FATHALLA Nadia, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846285
- Sponsor's protocol ID
- CASPeR
- Acronym
- CASPeR
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Low Digestive Bleeding in Proctology
- ClinicalTrials.gov ID
- NCT02846285
- Acronym / sponsor ID
- CASPeR / CASPeR
- Conditions
- Lower Gastrointestinal Tract, Colorectal Surgery, Proctology
- Keywords
- Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Jul 2016 (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 various causes of bleeding Proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. Investigators wanted to evaluate this data as part of a specialized consultation. Investigators have prospectively collected the causes of gastrointestinal bleeding down the patients seen two of us in specialized proctology center. A clinical examination including an inspection, palpation and feel, and a anoscopy (when possible) were made during the consultation. Local levies referred (s) histological and / or infection were also carried out if necessary. When she had not been made, a colonic exploration was offered to all patients over 45 years and / or when indicated by the pathological context. When there were several possible causes, the clinician holding one that seemed to be the main. Patients consulting within four months postoperatively a proctology action were not included. The study period extended from September 2013 to July 2014 inclusive. The collection of anonymous data.
Detailed description
The various causes of bleeding Proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. Investigators wanted to evaluate this data as part of a specialized consultation. Investigators have prospectively collected the causes of gastrointestinal bleeding down the patients seen two of us in specialized proctology center. A clinical examination including an inspection, palpation and feel, and a anoscopy (when possible) were made during the consultation. Local levies referred (s) histological and / or infection were also carried out if necessary. When she had not been made, a colonic exploration was offered to all patients over 45 years and / or when indicated by the pathological context. When there were several possible causes, the clinician holding one that seemed to be the main. Patients consulting within four months postoperatively a proctology action were not included. The study period extended from September 2013 to July 2014 inclusive. The collection of anonymous data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Exploration was offered to all patients over 45 years and / or when indicated by the pathological context
Key inclusion criteria (1 listed)
- All patients with proctological context
Key exclusion criteria (1 listed)
- Patients refusing to participate
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 |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Assessment of causes and determine the origin of down gastrointestinal bleedings
Time frame: Within 4 months after surgery
Determine the origine of gastrointestinal bleedings from the below: * Internal hemorrhoidal pathology * Anal Fissure * Perianal Crohn lesions * Cryto-glandular Anal fistula * Thrombosis external hemorrhoidal * Anal condylomata and / or perianal * Syndrome solitary rectal ulcer without prolapse externalized * Ano-radiation proctitis * Anal dermatitis and / or perianal * Complete Rectal prolapse externalized * Ulcerative colitis Recto * other
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 27 Jul 2016.
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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.
FATHALLA Nadia, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Gastrointestinal Tract and Colorectal Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 27 Jul 2016. 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 France. 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.
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?
Assessment of causes and determine the origin of down gastrointestinal bleedings (time frame: Within 4 months after surgery). 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 27 Jul 2016.