ProctologyIDEPROCTONCT02881541
Study of the Benefit of a Nurse (IDE) Pre and Post-operative Framework in Proctology Outpatient Surgery
A study testing Enhanced support in people with Proctology and Surgery, run by Fondation Hôpital Saint-Joseph.
Trial summary
Evaluate the complement of patient care course in the development of proctology outpatient surgery (CAP) by providing: An additional preoperative nurse consultation day hospital And a phone call from a nurse at D + 1 of the operation This corresponds to a reinforced support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proctology, Surgery
- What is being tested?
- Enhanced support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2015to 4 May 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient man or woman major
- Patient primary surgery and requiring care in CAP
- Patient affiliated to a social security scheme or of such a scheme
Who cannot join
- Bedridden patient and / or not communicating
- Patient opposing his participation in the study after information
- Patient has already undergone anal surgery
About this study
Evaluate the complement of patient care course in the development of proctology outpatient surgery (CAP) by providing:
- An additional preoperative nurse consultation day hospital
- And a phone call from a nurse at D + 1 of the operation
This corresponds to a reinforced support.
Read the detailed description
Main objective of the study: help improve the care of patients in CAP including during their exit after surgery. To evaluate the quality of patient care related to this enhanced system is a lever of development assistance outpatient surgical activity.
Secondary Objectives: To evaluate the impact of this new organization
- Satisfaction of patients and caregivers
- The effectiveness of the management of patients' pain
Study period: 3 months extendable a month, no start date announced
Workforce to include 100 patients at 3 months (10 per week), 50 in the "enhanced support" group and 50 in the group "usual care"
Expected results:
The main objective evaluation criteria: Evaluation support the success rate.
Evaluation performed 45 days after the patient's surgery.
Secondary objectives: patient satisfaction (telephone questionnaire to 45 days of operation), caregivers, pain assessment (painkillers booklet completed by the patient during his first consultation), consultation or rehospitalization for emergency patients and finally degree trust the doctor vis-à-vis this new support.
- Conditions
- Proctology, Surgery
- Being tested
- Enhanced support, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced supportProcedure or surgery
Usual careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients having Enhanced Support | Experimental | * A preoperative consultation with a nurse. This time will be dedicated to the preparation of returning home: explanation of the clinical pathway, realization of postoperative wound care, information on pain management and answer any questions the patient.
* A nurse call on D + 1, the day after the operation to ensure the smooth running of returning home, assess postoperative pain, the correct performance of local care, answer questions from the patient, and provide advice to to limit pain .. A reminder to J2 / J3 will be produced at the request of the patient or on FDI initiative if particular difficulties are reported Receives: Procedure: Enhanced support |
| Patients having usual care | Experimental | no intervention will be made for this group. Patients will receive usual care respecting intern procedure Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the success rate of the treatment using intern questionary score
Measured: Day 45 after surgery
Secondary outcomes (1)
Assessment of patient satisfaction by intern phone questionary Score
Measured: Day 45 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start4 May 2015 (estimated)
- Primary completion4 May 2015 (estimated)
- Study completion4 May 2015 (estimated)
Why it stopped: The investigator abandoned the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProctologyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tasseau P Angélique, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881541
- Sponsor's protocol ID
- IDEPROCTO
- Acronym
- IDEPROCTO
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2016
- Last updated
- 13 Aug 2018
- 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 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Benefit of a Nurse (IDE) Pre and Post-operative Framework in Proctology Outpatient Surgery
- ClinicalTrials.gov ID
- NCT02881541
- Acronym / sponsor ID
- IDEPROCTO / IDEPROCTO
- Conditions
- Proctology, Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigator abandoned the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 4 May 2015 (estimated)
- Primary completion
- 4 May 2015 (estimated)
- Study completion
- 4 May 2015 (estimated)
- First posted
- 29 Aug 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.
Evaluate the complement of patient care course in the development of proctology outpatient surgery (CAP) by providing:
- An additional preoperative nurse consultation day hospital
- And a phone call from a nurse at D + 1 of the operation
This corresponds to a reinforced support.
Detailed description
Main objective of the study: help improve the care of patients in CAP including during their exit after surgery. To evaluate the quality of patient care related to this enhanced system is a lever of development assistance outpatient surgical activity.
Secondary Objectives: To evaluate the impact of this new organization
- Satisfaction of patients and caregivers
- The effectiveness of the management of patients' pain
Study period: 3 months extendable a month, no start date announced
Workforce to include 100 patients at 3 months (10 per week), 50 in the "enhanced support" group and 50 in the group "usual care"
Expected results:
The main objective evaluation criteria: Evaluation support the success rate.
Evaluation performed 45 days after the patient's surgery.
Secondary objectives: patient satisfaction (telephone questionnaire to 45 days of operation), caregivers, pain assessment (painkillers booklet completed by the patient during his first consultation), consultation or rehospitalization for emergency patients and finally degree trust the doctor vis-à-vis this new support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients having Enhanced Support | Experimental | Procedure: Enhanced support* A preoperative consultation with a nurse. This time will be dedicated to the preparation of returning home: explanation of the clinical pathway, realization of postoperative wound care, information on pain management and answer any questions the patient. * A nurse call on D + 1, the day after the operation to ensure the smooth running of returning home, assess postoperative pain, the correct performance of local care, answer questions from the patient, and provide advice to to limit pain .. A reminder to J2 / J3 will be produced at the request of the patient or on FDI initiative if particular difficulties are reported |
| Patients having usual care | Experimental | Procedure: Usual careno intervention will be made for this group. Patients will receive usual care respecting intern procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient man or woman major
- Patient primary surgery and requiring care in CAP
- Patient affiliated to a social security scheme or of such a scheme
Key exclusion criteria (3 listed)
- Bedridden patient and / or not communicating
- Patient opposing his participation in the study after information
- Patient has already undergone anal surgery
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 |
|---|---|---|
| Enhanced support | Procedure or surgery | Patients having Enhanced Support |
| Usual care | Procedure or surgery | Patients having usual care |
Primary outcome
Assessment of the success rate of the treatment using intern questionary score
Time frame: Day 45 after surgery
1 secondary outcome
Assessment of patient satisfaction by intern phone questionary Score
Time frame: Day 45 after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- 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.
Tasseau P Angélique, MD principal investigator
Fondation Hôpital Saint-Joseph
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced support in people with Proctology and Surgery, run by Fondation Hôpital Saint-Joseph.
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 3 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: withdrawn, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 the success rate of the treatment using intern questionary score (time frame: Day 45 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 13 Aug 2018.