Modified Diaphragmatic Plication Rectifies Dyspnea

NCT ID: NCT06775873

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-06-01

Brief Summary

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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

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Conditions

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Phrenic Nerve Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Modified 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji University

OTHER

Sponsor Role lead

Responsible Party

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Jiang Fan

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai General Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Hongkou Distri, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 3927067 (View on PubMed)

Other Identifiers

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0347130

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MDP 010

Identifier Type: -

Identifier Source: org_study_id

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