NCT05915559

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

June 13, 2023

Last Update Submit

August 19, 2025

Conditions

TonsillectomyPainAmbulatory

Keywords

TonsillectomyPainambulatory

Outcome Measures

Primary Outcomes (1)

  • Number of patients EVA score less or equal at 3

    EVA score is a pain scale from 0 to 10. 10 is the highest pain level.

    day 1

Study Arms (1)

Tonsillectomy

EXPERIMENTAL
Procedure: TonsillectomyOther: daily follow-up

Interventions

TonsillectomyPROCEDURE

Tonsillectomy

Tonsillectomy
daily follow-upOTHER

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

Tonsillectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Pain

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 23, 2023

Study Start

June 1, 2023

Primary Completion

May 17, 2025

Study Completion

November 1, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)