New Quality Assessment for IBD Surgery: Identification of the clinical variables that will allow assessment of the IBD surgical quality and improvement of the IBD surgical outcomes

Acknowledgement: This article is a summary of “The ACS National Surgical Quality Improvement Program- Inflammatory Bowel Disease Collaborative: Design, Implementation, and Validation of a Disease-Specific Module” published in the November 2019 issue of Inflammatory Bowel Diseases by Samuel Eisenstein, Stefan D. Holubar, Nicholas Hilbert, Liliana Bordeianou, Lynne A. Crawford1, Bruce Hall, Tracy Hull, Neil Hyman, Megan Keenan, Hiroko Kunitake5, Edward C. Lee, William D. Lewis, David Maron , Evangelos Messaris, Reba Miller, Matthew Mutch, Gail Ortenzi, Sonia Ramamoorthy, Radhika Smith, Randolph M. Steinhagen, Steven D. Wexner The article was written by Nataly Shtraizent, PhD, Research Manager at the Crohn’s & Colitis Foundation.

Among patients with inflammatory bowel disease (IBD), 23 to 45 percent of people with ulcerative colitis and up to 75 percent of people with Crohn’s disease will eventually require surgery.1 Surgery for IBD is very complex and the outcomes may be influenced of multiple factors, such as disease activity, pre-operative disease management, and surgical approach. Due to the interplay of these factors, surgery exposes IBD patients to an increased risk of complications compared to patients without IBD.

Pre-operative management of IBD is an important factor which could define surgical outcomes and should be considered in deciding on the surgical approach. For instance, IBD management often involves medications which suppress immune response and can impair wound healing, (1) (2) leaving patients at risk for poor surgical outcomes. It is well-established that several factors, such as steroids (3) (4) (5) (6), malnutrition (7) (8), anemia (9), and sepsis (6), can increase the risk for post-operative complications across all types of surgeries. However, while accounting for these factors, it could be difficult to identify which surgical methods can improve the quality of surgery for IBD and decrease the risk of complications.

The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) is a network of 708 sites across the United States, collecting pre- and post-operative patient data, capturing over 1 million cases. Published research studies have analyzed outcomes after ulcerative colitis (UC) surgery in NSQIP but have not been able to tease out the nuances of care critical to surgery for IBD as data specific to IBD surgery was, until recently, not collected. The article by Samuel Eisenstein and colleagues, describes an ongoing study and their effort to expand NSQIP to include IBD-relevant variables in order to improve quality assessment for IBD surgery. In their study, Eisenstein and his collaborators collected IBD-specific surgical data from 13 institutions over the course of one year. The research group analyzed the reliability of the data and identified challenges in the data collection process.  Addressing these challenges and analyzing the data collected though the NSQIP will help identify factors contributing to optimal outcomes for this at-risk surgical population.

The NSQIP-IBD Collaborative started with 13 institutions which performed high volumes of IBD surgery. Participants discussed IBD-relevant variables and the infrastructure required for data collection. Variables were chosen on a limited basis where data was not currently well-captured via NSQIP. The collaborative agreed to focus on a small number of reliable variables that are likely inform treatment strategies and on centers with high volume of IBD surgeries (>20 IBD operations per year) that follow NSQIP standard methodology. The 5 variables and their definitions are listed in Table 1.

Over the first year, 956 IBD cases, including colectomies and proctectomies, were abstracted from 13 centers. Of these cases, 41.4% of the patients had taken a biologic agent within 60 days of surgery and 16.3% had taken thiopurine or methotrexate. The majority of cases involved ileostomy (543/956, 56.8%), 134 (14.0%) procedures involved ileal pouch-anal anastomosis, and 80 (8.4%) procedures were performed for colonic dysplasia or cancer.

While evaluating the clinical records related to the patients participating in the study, the team identified several problems in the way the data is collected in NSQIP, and accordingly, proposed approaches for process optimization. For example, the same surgical procedures can be performed in different ways. However, when inputting a patient’s clinical data in NSQIP, surgeons are not able to specify the nuances of surgical methods because the type of surgical procedure is captured through CPT codes designed for billing purposes. Being able to capture information about the type of surgery and the method utilized helps better predict of the overall perioperative course, i.e.  whether the patient is at increased risk for pelvic sepsis (17) (18) or an early postoperative small bowel obstruction (20) (21), which is exactly what NSQIP was designed to accomplish.

Another IBD-relevant variable, addressed by the study, is the effect of pre-operative use of biologics on post-operative wound healing and risk of complications (22) (2). There is an ongoing debate in the literature, e.g. on the role of anti-Tumor Necrosis Factor-α on IBD surgical outcomes, and multiple studies show conflicting data. In the present collaborative, the team developed an approach to better capture patient data in clinical records in order to more clearly address the association between biologics on post-operative course of disease. Specifically, to distinguish if a patient’s pre-operative IBD management should be recorded as “on-biologics” or not, the factor to be considered is clinically relevant window, i.e. how long a particular biologic treatment remains in the blood circulation. The team concluded, 60 days is the optimal clinical timepoint, namely, if 60 days has passed after the patient received the last biologic treatment, the patient can be considered non-treated with biologics. This approach may inform the choice of IBD management for patients in the higher risk category for surgery, as well as the choice of a surgical method.

This is one of the first real-world observational studies using a validated clinical database and incorporating novel, disease-specific and reliably captured variables specific to this at-risk population. NSQIP is limited by its 30-day post-operative window, thus many important IBD questions, such as functional outcomes, will require much longer studies. Still, this is an important first step in switching the way we follow outcomes for IBD surgery patients. By addressing the challenges in data collection, the research team will develop a uniform process to create a reliable database and will continue to fine tune the process to ensure the valid data. In the next phase, the Collaborative plans to expand both membership and data points and start analyzing these data for outcomes information to help establish best practices in IBD surgery.

References:
  1. Backhed F, Ley RE, Sonnenburg JL, et al. Host-bacterial mutualism in the human intestine. Science. 2005;307:1915–20.

Table 1.

  1.  Ileostomy formation (Ileost): Please indicate if an Ileostomy was created at the time of the procedure.

    1. None

    2. New Ileostomy

    3. Ileostomy from prior is unaltered

    4. Conversion of end Ileostomy to loop 

  2. Biologic agent 60 days prior to surgery (BioMed): Was the patient on a biologic agent at any point over the 60 day period prior to surgery?  This includes but is not limited to:  Infliximab (Remicade), Adalimumab (Humira), Certolizumab Pegol (Cimzia), Golimumab (Simponi), Vedolizumab (Entyvio), Natalizumab (Tysabri), Ustekinumab (Stelara), Tofacitinib (Xeljanz).

    1. No

    2. Yes

    3. Unable to determine 

  3. Immune modulation 60 days prior to surgery (ImmMod): Was the patient taking immune modulation therapy at any point over the 60 day period prior to surgery.  This includes: 6-mercaptopurine (6-MP, Purinethol, Purixan), Azathioprine (Imuran, AZA), Methotrexate (MTX, Trexall, Rasuvo, Methotrexate LPF Sodium, Folex PFS).

    1. No

    2. Yes

    3. Unable to determine 

  4.  IPAA anastomosis (Mucos):  For an IIeal pouch (CPT:  45113, 44158, 44211) created for ulcerative colitis, please describe the anastomotic technique.

    1. Not applicable

    2. Double staple

    3. Mucosectomy with hand sewing

    4. Hand Sewn without mucosectomy

    5. Other 

  5. Colonic Dysplasia (Dyspl):  For patients undergoing colectomy, did the patient have known dysplasia prior to the surgery or was there dysplasia found in the surgical specimen? For patients found to have both high and low grade dysplasia, please list high grade.

    1. Unable to determine

    2. No Dysplasia

    3. Low grade Dysplasia

    4. High Grade Dysplasia

    5. Colorectal Cancer

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