SPAIN Chest Wall Deformity Project (Pectus Repair)
Condition: Deformity of Chest Wall
MeSH terms: Congenital Abnormalities
Study type: Observational [Patient Registry]

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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals undergoing surgical procedures on the chest wall region performed to correct
        Pectus Excavatum deformities.
      
Keywords: Pectus Excavatum