NCT07035366

Brief Summary

highly elevated abnormal diaphragm is lowered to normal position by runuing suture accordion shaped or cut part of diphragm by stabler

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.9 years

First QC Date

June 12, 2025

Last Update Submit

June 23, 2025

Conditions

Diaphragmatic Eventration

Keywords

stabled resectionrunning suturesdiaphragmatic eventration

Outcome Measures

Primary Outcomes (4)

  • Cosmetic & Recovery Time (days)

    1 week after surgery

  • operative time (min)

    from the start of skin incision till the extubation of the patient

  • postoperative pain(pain score)

    postoperative pain recieved by operated patient

  • lung function recovery (lung function test)

    forced expiratory volume in 1st second,

    lung function test done one and three months postoperative

Study Arms (2)

running sutures

EXPERIMENTAL

diaphragmatic plication by running sutures

Procedure: running sutures

stabled resection

EXPERIMENTAL

diaphragmatic plication by stabled resection

Procedure: stabled resection

Interventions

stabled resectionPROCEDURE

diaphragmatic plication of sever eventration by stabled resection

stabled resection
running suturesPROCEDURE

plication of diaphragmatic eventration by running sutures

running sutures

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who presented with dyspnea or orthopnea with sever eventration

You may not qualify if:

  • other causes of dyspnea or elevated hemidiaphragm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt

Zagazig, Sharqia Province, 44519, Egypt

Location

cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt

Zagazig, Sharqia Province, 44519, Egypt

Location

Cardiothoracic Surgery Department-Faculty of Mdecine-Zagazig Univeristy

Zagazig, Sharqia Province, Egypt

Location

MeSH Terms

Conditions

Diaphragmatic Eventration

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 25, 2025

Study Start

January 15, 2023

Primary Completion

December 10, 2024

Study Completion

March 15, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)