AMYAMBU: Outpatient Management of Tonsillectomy in Adults

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05915559

Collaborator

Centre Hospitalier de Beauvais (Other), Centre Hospitalier Abbeville (Other)

Enrollment

Location

Arm

17.1

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an intravenous analgesia. The aim is to set up a protocol for ambulatory care of adult tonsillectomies. Then, it would allow an improvement of the postoperative quality of life for the patient, who prefers a quicker return home.The study aims to allow patients to come back home early after tonsillectomies with intravenous analgesia. Pain, feeding and quality of life will be evaluated regularly through an application called MAELA during a few days after surgery. They will also be evaluated by nurses coming via providers.

Condition or Disease	Intervention/Treatment	Phase
Tonsillectomy Pain Ambulatory	Procedure: Tonsillectomy Other: daily follow-up	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Outpatient Management of Tonsillectomy in Adults

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tonsillectomy	Procedure: Tonsillectomy Tonsillectomy Other: daily follow-up daily follow-up of clinical parameters (pain, feeding) and analgesia adapted to the pain

Arm

Intervention/Treatment

Experimental: Tonsillectomy

Procedure: Tonsillectomy

Tonsillectomy

Other: daily follow-up

daily follow-up of clinical parameters (pain, feeding) and analgesia adapted to the pain

Outcome Measures

Primary Outcome Measures

Number of patients EVA score less or equal at 3 [day 1]
EVA score is a pain scale from 0 to 10. 10 is the highest pain level.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Indication for a tonsillectomy defined in the French recommendations
Age between 18 and 60 yo
Providing free and informed consent to participate
Having a smartphone able to process MAELA application
Affiliation to french social security

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens
Centre Hospitalier de Beauvais
Centre Hospitalier Abbeville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT05915559

Other Study ID Numbers:

PI2022_843_0115

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Tonsillectomy

Pain

ambulatory

Study Results

No Results Posted as of Jun 23, 2023