Study of the Benefit of a Nurse (IDE) Pre and Post-operative Framework in Proctology Outpatient Surgery (IDEPROCTO)

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.

Study Overview

• Status: Withdrawn
• Conditions: Surgery; Proctology
• Intervention / Treatment: Procedure: Usual care; Procedure: Enhanced 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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients having 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	Procedure: Enhanced support
EXPERIMENTAL: Patients having usual care; no intervention will be made for this group. Patients will receive usual care respecting intern procedure	Procedure: Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the success rate of the treatment using intern questionary score	Day 45 after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of patient satisfaction by intern phone questionary Score	Day 45 after surgery

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Tasseau P Angélique, MD, Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 4, 2015
• Primary Completion (ANTICIPATED): May 4, 2015
• Study Completion (ANTICIPATED): May 4, 2015

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (ESTIMATE): August 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IDEPROCTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No