Modified Diaphragmatic Plication Rectifies Dyspnea

Tongji University50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Phrenic Nerve Injury

Interventions

Modified diaphragmatic plicationPROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Hongkou Distri, China

Outcomes

Primary Outcomes

Effective rates of prevention of diaphragmatic elevation

Time frame: 1 year

Success in correcting diaphragmatic elevation

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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