Clinical trial NCT03770390: Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
Official title: Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Funnel Chest
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 70
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This single group study documents changes before and after surgical correction of pectus excavatum.
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.

Detailed description: The secondary objectives are:

* To measure the quality of life of patients operated on for pectus excavatum
* Identify and describe post-operative complications
* Follow-up on the body mass index changes post-surgery
* Evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is placed non-invasively

Eligibility criteria: Inclusion Criteria:

* Patient with pectus excavatum
* The patient received corrective surgery within four years of enrollment and is scheduled for a follow-up visit --OR-- the patient is scheduled for corrective surgery during the inclusion period
* Collection of informed written consent (patient and legal guardian, if applicable)
* Obligation of affiliation or beneficiary of a social security programme

Exclusion Criteria:

* Impossibility for the patient to participate in his/her next annual follow-up visit
* Absence of exercise test data AND respiratory function test data performed during the preoperative check-up
* Subject in exclusion period required by another protocol
* Pregnant or lactating woman, patient unable to give consent, protected adult, vulnerable persons (according to French Health Code articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
* Subject deprived of liberty by judicial or administrative decision
* Participation of the subject in another interventional protocol
* Failure to properly inform the patient (e.g. a language barrier)

Primary outcomes:
measure: Change in: Oxygen pulse (mL O2 / heart beat)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Secondary outcomes:
measure: Change in: Body mass index (kg/m^2)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: The presence/absence of dyspnea during exercise
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: The presence/absence of palpitations
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: The presence/absence of psychosocial impact
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: VO2MAX (ml/kg/min)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: VO2MAX (% predicted)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Maximum heart rate (bpm)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Presence/absence of an anomaly in oxygen pulse
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Ventilatory threshold (% of VO2MAX)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Breathing Reserve (% of maximum voluntary ventilation)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced expiratory volume in 1 second (liters)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced expiratory volume in 1 second (% predicted)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced vital capacity (liters)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced vital capacity (% predicted)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Forced expiratory volume in 1 second (litres) / forced vital capacity (litres)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Residual volume (liters)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Residual volume (% predicted)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Total lung capacity (liters)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Total lung capacity (% predicted)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Residual volume / Total lung capacity (liters/liters)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Functional residual capacity (liters)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: Change in: Functional residual capacity (% predicted)
timeFrame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
measure: The SF36 questionnaire
timeFrame: post-op (expected maximum of 4 years)
measure: The Body Esteem Scale
timeFrame: post-op (expected maximum of 4 years)
measure: The Rosenberg Self Esteem Scale
timeFrame: post-op (expected maximum of 4 years)
measure: Complications
timeFrame: per-op up to expected maximum of 4 years
measure: Blood pressure (average, mmHg)
timeFrame: during surgery (day 0)
measure: Pulse
timeFrame: during surgery (day 0)
measure: Oxygen saturation (SpO2, %)
timeFrame: during surgery (day 0)
measure: Cardiac index (liters/min/m^2)
timeFrame: during surgery (day 0)
measure: Variation in ejection volume (%)
timeFrame: during surgery (day 0)
measure: Indexed systolic ejection volume (ml/beat/m2)
timeFrame: during surgery (day 0)
measure: Cumulative dose of vasopressors
timeFrame: during surgery (day 0)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier
Study officials:
affiliation: University Hospitals of Montpellier, France
name: Laurence Solovei, MD
role: PRINCIPAL_INVESTIGATOR
References: