Modified Diaphragmatic Plication Rectifies Dyspnea

Modified Diaphragmatic Plication Rectifies Dyspnea With Diaphragmatic Eventration Caused by Phrenicotomy or Injuries Involved in Extended Mediastinal Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Phrenic Nerve Injury
• Intervention / Treatment: Procedure: Modified diaphragmatic plication

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Hongkou Distri
    • Shanghai, Hongkou Distri, China, 200080
      • Shanghai General Hospital shanghai jiao tong university school of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients who underwent mediastinal tumor resection and MDP between 2020 and 2024 at Shanghai General Hospital. All patients underwent plain chest X-ray or computed tomography (CT) scans prior to surgery to confirm diaphragmatic elevation. Each patient was followed for a minimum of six months.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effective rates of prevention of diaphragmatic elevation	1 year
Success in correcting diaphragmatic elevation	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 year

Collaborators and Investigators

• Sponsor: Tongji University

Publications and helpful links

General Publications

• Wright CD, Williams JG, Ogilvie CM, Donnelly RJ. Results of diaphragmatic plication for unilateral diaphragmatic paralysis. J Thorac Cardiovasc Surg. 1985 Aug;90(2):195-8.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: MDP 010; 0347130 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No