Modified Diaphragmatic Plication Rectifies Dyspnea

NCT06775873 | Completed DMC

• 2 other identifiers: MDP 0100347130
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Phrenic Nerve Injury

Outcome Measures

Primary Outcomes (2)

• Effective rates of prevention of diaphragmatic elevation

  1 year

• Success in correcting diaphragmatic elevation

  1 year

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 year

Interventions

Modified diaphragmatic plication PROCEDURE

Modified diaphragm plication (MDP) using a cutting stapler consists of four steps: clamping and lifting, depressing and resecting, cutting and verifying, and hemostasis and reinforcement.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Hongkou Distri, 200080, China

Location

Related Publications (1)

• 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.

  PMID: 3927067 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 15, 2025
• Study Start: February 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

CN (1)