Modified Diaphragmatic Plication Rectifies Dyspnea

Completed

• Conditions: Phrenic Nerve Injury

• Registration Number: NCT06775873
• Lead Sponsor: Tongji University

Brief Summary

Traditional diaphragmatic plication (DP) surgery is employed to ameliorate respiratory function in patients with diaphragmatic paralysis, which is rather complicated. This study introduces a modified method of DP. The efficacy of modified diaphragmatic plication (MDP) in preventing, treating, and relieving dyspnea in patients with phrenic nerve resection or injury due to extensive surgical intervention or local tumor invasion will be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-05-01
• Study Completion: 2024-06-01
• Study First Submitted: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Preoperative chest X-ray suggesting diaphragmatic eventration, for which therapeutic MDP was performed;
• Mediastinal tumors encircling the phrenic nerve that could not be dissected or phrenic nerve injury occurring during intraoperative dissection, for which prophylactic MDP was performed;
• Diaphragmatic eventration and dyspnea following mediastinal surgery, for which salvage MDP was performed.

Exclusion Criteria

• Congenital diaphragmatic deformity or diaphragmatic weakness due to poor general nutritional status;
• Morbid obesity with a BMI greater than 35 kg/m2;
• Neuromuscular diseases, including amyotrophic lateral sclerosis and myasthenia gravis;
• A history of upper abdominal surgery; and (5) Diaphragmatic calcification or fibrosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effective rates of prevention of diaphragmatic elevation	1 year
Success in correcting diaphragmatic elevation	1 year

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 year

Trial Locations

Locations (1)

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Hongkou Distri, China