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

NCT02881541 | Withdrawn DMC

• 1 other identifier: IDEPROCTO
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Proctology; Surgery

Outcome Measures

Primary Outcomes (1)

• Assessment of the success rate of the treatment using intern questionary score

  Day 45 after surgery

Secondary Outcomes (1)

• Assessment of patient satisfaction by intern phone questionary Score

  Day 45 after surgery

Study Arms (2)

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

Procedure: Enhanced support

Patients having usual care

EXPERIMENTAL

no intervention will be made for this group. Patients will receive usual care respecting intern procedure

Procedure: Usual care

Interventions

Enhanced support PROCEDURE

Patients having Enhanced Support

Usual care PROCEDURE

Patients having usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Bedridden patient and / or not communicating
• Patient opposing his participation in the study after information
• Patient has already undergone anal surgery

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Officials

• Tasseau P Angélique, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: May 4, 2015
• Primary Completion: May 4, 2015
• Study Completion: May 4, 2015
• Last Updated: August 13, 2018

Record last verified: 2018-08