Modified Diaphragmatic Plication Rectifies Dyspnea

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06775873

Enrollment

Registered

2025-01-15

Start date

2023-02-01

Completion date

2024-06-01

Last updated

2025-01-15

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

Conditions

Phrenic Nerve Injury

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.

Interventions

PROCEDUREModified diaphragmatic plication

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.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026