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NCT02098681 · ClinicalTrials.gov registry record

SPAIN Chest Wall Deformity Project (Pectus Repair)

A clinical trial, sponsored by Boston Children's Hospital.

Completed
Registry status
348
Enrollment target

NCT02098681 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 348 participants.

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The verdict

NCT02098681 has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
348 participants
Enrollment target

Study Summary

Context: Chest wall deformities in children are relatively common. One such deformity, known as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of these abnormalities - present in approximately 1 out of every 400-1000 births. This deformity is often a cosmetic problem for affected individuals. When severe, PE can also be associated with cardiopulmonary compromise. Treatment of PE involves surgical correction. There are several potential methods for correcting PE. In the past the most common repair involved an open procedure which involves excision and reshaping of the ribcage. More recently a minimally invasive procedure has been adopted involving the placement of a stainless steel or titanium bar underneath the sternum to reshape the chest wall. This procedure, commonly known as the Nuss procedure, carries with it significant post-operative pain management problems. In fact, the pain issues after Nuss procedure may be more significant than after open repair. The quality of postoperative pain control in these cases has been shown to affect several measurable objective outcomes during hospitalization including capacity for deep breathing, early mobilization, ambulation, and length of hospital stay. Epidural analgesia (EA) has been one of the standard methods for managing pain in the early postoperative period after PE repair. Unfortunately severe pain may persist after the removal of an epidural catheter resulting in a difficult "transition" period just prior to discharge from the hospital. In addition reports of neurological injury after epidural analgesia for Nuss procedures have appeared. In light of these issues, many institutions have opted for alternative methods of pain control including peripheral nerve blocks, patient controlled analgesia, and wound catheters. There remains significant debate as to which pain control methodology is best. There is little consistent data available on pain control or outcomes that occur afte

Trial Details

FieldValue
Enrollment Target 348 participants
Start Date 2014-01
Est. Completion 2018-09

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT02098681

The ClinicalTrials.gov registry entry for NCT02098681 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 348 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT02098681 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02098681 about?

NCT02098681 is a clinical study titled "SPAIN Chest Wall Deformity Project (Pectus Repair)". Context: Chest wall deformities in children are relatively common. One such deformity, known as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of these abnormalities - present in approximately 1 out of every 400-1000 births. This deformity is often a cosmetic probl...

What is the current status of trial NCT02098681?

This trial is currently completed. The enrollment target is 348 participants. The study started on 2014-01. Estimated completion is 2018-09.

Who is sponsoring clinical trial NCT02098681?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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