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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02881541
Other study ID # IDEPROCTO
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 4, 2015
Est. completion date May 4, 2015

Study information

Verified date August 2018
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 4, 2015
Est. primary completion date May 4, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Bedridden patient and / or not communicating

- Patient opposing his participation in the study after information

- Patient has already undergone anal surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Enhanced support

Usual care


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the success rate of the treatment using intern questionary score Day 45 after surgery
Secondary Assessment of patient satisfaction by intern phone questionary Score Day 45 after surgery
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