NCT03770390

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

December 16, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

December 4, 2018

Last Update Submit

September 24, 2025

Conditions

Funnel Chest

Outcome Measures

Primary Outcomes (1)

  • Change in: Oxygen pulse (mL O2 / heart beat)

    Recorded during incremental exercise testing.

    post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

Secondary Outcomes (33)

  • Change in: Body mass index (kg/m^2)

    post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  • Change in: The presence/absence of dyspnea during exercise

    post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  • Change in: The presence/absence of palpitations

    post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  • Change in: The presence/absence of psychosocial impact

    post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  • Change in: VO2MAX (ml/kg/min)

    post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  • +28 more secondary outcomes

Study Arms (1)

The study population

OTHER

Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period. Intervention: Surgical correction of pectus excavatum

Procedure: Surgical correction of pectus excavatum

Interventions

Surgical correction of pectus excavatumPROCEDURE

Surgical correction of pectus excavatum

The study population

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with pectus excavatum
  • Collection of informed written consent (patient and legal guardian, if applicable)
  • Obligation of affiliation or beneficiary of a social security programme

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Suehs CM, Molinari N, Bourdin A, Solovei L. Change in cardiorespiratory parameters following surgical correction of pectus excavatum: protocol for the historical-prospective HeartSoar cohort. BMJ Open. 2023 Jun 15;13(6):e070891. doi: 10.1136/bmjopen-2022-070891.

    PMID: 37321811DERIVED

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Laurence Solovei, MD

    University Hospitals of Montpellier, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This single group study documents changes before and after surgical correction of pectus excavatum.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 10, 2018

Study Start

December 16, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations

FR(1)