Conservative and surgical therapy of unilateral diaphragmatic paralysis and paresis

Conservative and surgical therapy of unilateral diaphragmatic paralysis and paresis - Cologne

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024912

Enrollment

Registered

2021-03-25

Start date

2021-05-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J98.6 G54.5 G54.9

Interventions

Group 1: Surgical therapy: Diaphragmatic lifting and stabilisation by means of prolene reticuloplasty Group 2: Conservative therapy: inspiratory respiratory muscle training

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: - Indication for conservative or surgical treatment of unilateral diaphragmatic paralysis with consecutive diaphragmatic hernia - First diagnosis at least one year ago without signs of recovery - Walking distance in the 6-minute walking test >300m and <600m - Informed and signed consent

Exclusion criteria

Exclusion criteria: - Inoperability according to ASA criteria, i.e. ASA > 3 - Persons who are in a dependent or employment relationship with the investigator. - Placement in an institution due to court or official order - Incapacitated patient - Pregnancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
Is the change in supine FEV1 before and after surgical and conservative therapy for unilateral diaphragmatic paralysis.	—

Secondary

Measure	Time frame
Improvement of health-related quality of life after surgical and conservative therapy, measured with the specific DPQ questionnaire, the use of which has already been approved by the Ethics Committee Witten/Herdecke (application number 12/2018). Improvement of walking distance in the 6-minute walking test as well as improvement of spirometric, bodyplethysmo-graphic, ergospirometric and respiratory muscular functions. Improvement of any pre-existing hypercapnia. Possible clustering of radiculopathies at C4 level, in the patient population with idiopathic genesis of unilateral diaphragmatic herniation. Possible clustering of a lesion of the upper parts of the cervicobrachial plexus.	—

Measure

Time frame

Improvement of health-related quality of life after surgical and conservative therapy, measured with the specific DPQ questionnaire, the use of which has already been approved by the Ethics Committee Witten/Herdecke (application number 12/2018). Improvement of walking distance in the 6-minute walking test as well as improvement of spirometric, bodyplethysmo-graphic, ergospirometric and respiratory muscular functions. Improvement of any pre-existing hypercapnia. Possible clustering of radiculopathies at C4 level, in the patient population with idiopathic genesis of unilateral diaphragmatic herniation. Possible clustering of a lesion of the upper parts of the cervicobrachial plexus.

—

Countries

Germany, Italy

Contacts

Public ContactNils Jurriaan Kosse

Lungenklinik Merhein, Abt. Thoraxchirurgie, Kliniken der Stadt Köln gGmbH

kossen@kliniken-koeln.de0221-8907-8640

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026