SPAIN Chest Wall Deformity Project (Pectus Repair)

NCT02098681 | Completed

• 1 other identifier: IRB-P00010229
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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 after EA is stopped. Moreover there is reluctance in any one institution to trial or randomize patients to a variety of treatment modalities. For all of these reasons, investigators are proposing participation in a multi-institutional data sharing project concerning the repair of EA in which participating centers will collaborate to better understand the outcomes of perioperative care for patients undergoing correction of this problem.

Conditions

Deformity of Chest Wall

Keywords

Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

• Perioperative course and management of children undergoing Pectus Excavatum repair surgery.

  Peri- and Post-Operative Pain Control

  Baseline, Daily up to Three Weeks

Secondary Outcomes (9)

• Perioperative course and management of children undergoing Pectus Excavatum repair surgery.

  Baseline

• Perioperative course and management of children undergoing Pectus Excavatum repair surgery.

  Baseline

• Perioperative course and management of children undergoing Pectus Excavatum repair surgery.

  Baseline

• Perioperative course and management of children undergoing Pectus Excavatum repair surgery.

  Baseline

• Perioperative course and management of children undergoing Pectus Excavatum repair surgery.

  Baseline, up to Three Weeks

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals undergoing surgical procedures on the chest wall region performed to correct Pectus Excavatum deformities.

You may qualify if:

• Males and females ages 8 to 30 years.
• Undergoing surgical procedures on the chest wall region performed to correct Pectus Excavatum deformities.

You may not qualify if:

• None.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Johns Hopkins All Children's Hospital: collaborator
• Children's Hospital Colorado: collaborator
• Children's Hospital Los Angeles: collaborator
• Children's Hospital of Philadelphia: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Alfred I. duPont Hospital for Children: collaborator
• Emory University: collaborator
• Johns Hopkins University: collaborator
• Mayo Clinic: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joseph P Cravero, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 28, 2014
• Study Start: January 1, 2014
• Primary Completion: October 20, 2015
• Study Completion: September 1, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

US (1)