SPAIN Chest Wall Deformity Project (Pectus Repair)
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 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.
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 400-1000births. 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.

 The primary objective is to create a multicenter registry which captures data relating to the
 perioperative course and management of children undergoing PE repair surgery. This effort is
 undertaken in order to augment safety and quality improvement activities at participating
 sites. Investigators understand that there are multiple methodologies for accomplishing the
 anesthesia and perioperative pain control for this surgery. There is little comparative data
 on the outcomes from the different possible management strategies. Given the relative
 frequencies of these surgeries where few centers perform more than 20-50 of these procedures
 per year, it is not practical for any one (or two) centers to study this procedure in an
 observational manner or a controlled randomized trial. Investigators' aggregate
 multi-institutional data set will be used for benchmarking for both local and national safety
 and quality improvement efforts. Participating sites will be provided with reports comparing
 the local site to the aggregate dataset for specific perioperative outcome variables (e.g.
 pain metrics) and factors that could be associated with improved outcomes. Outcome variables
 include but are not limited to intraoperative hemodynamics, pain control, emergence
 agitation, apnea/airway obstruction, hemodynamic stability, time to first ambulation, pain
 scores while in the hospital, total hospital days, time to school or work attendance, and
 symptoms of post-traumatic stress.

 Secondary objective: Investigators will ultimately look at the relationship between specific
 management metrics such as the use of epidural anesthesia vs. peripheral nerve blocks vs.
 local anesthesia wound infiltration and our primary outcome metrics. In addition
 Investigators will consider the frequency of long term Post Traumatic Stress behaviors and
 the various measures of pain control in the perioperative period.

 Study Design:

 Basic design: Prospective observational multicenter data registry

 Setting/Participants:

 -  Patients ages 8 to 30 years undergoing surgery for Pectus Excavatum Repair in a hospital
 setting

 -  Up to 20 hospital sites

 Data Collection, Storage and Release:

 The registry will capture data relating to the perioperative management of children
 undergoing PE repair. Measures will include demographic data, data on degree of deformity,
 perioperative management, intraoperative management, hospital course, surgical technique,
 complications, and long term pain/psychological outcomes.
Inclusion Criteria:

 -  Males and females ages 8 to 30 years.

 -  Undergoing surgical procedures on the chest wall region performed to correct Pectus
 Excavatum deformities.

 Exclusion Criteria:

 -  None.