Abbreviations
AGREE
adverse events in gastrointestinal endoscopy
AL
anastomotic leaks
APR
abdominoperineal resection
ASA
American Society of Anesthesiologists
ASGE
American Society for Gastrointestinal Endoscopy
CCI
Charlson Comorbidity Index
CD
Crohn’s disease
CDCC
Clavien-Dindo complication classification
CES-D
Center for Epidemiological Studies-Depression
CGQOL
Cleveland Global Quality of Life
CI
confidence interval
CRC
colorectal cancer
DASS-21
Depression, Anxiety, and Stress Scale
EORTC QLQ-C
European Organization for Research and Treatment of Cancer
ESGE
European Society of Gastrointestinal Endoscopy
IBD
inflammatory bowel disease
IBDQ
Inflammatory Bowel Disease Questionnaire
IBS-QOL
irritable bowel syndrome-quality of life
IPAA
ileal pouch-anal anastomosis
IQR
interquartile range
IRR
incidence rate ratio
LAR
low anterior resection
LOS
length of stay
NIS
National Inpatient Sample
OR
odds ratio
QoL
quality of life
RPC
restorative proctocolectomy
RR
risk ratio
SF-36
Short-Form 36
SIBDQ
Short Inflammatory Bowel Disease Questionnaire
STAI
State-Trait Anxiety Inventory
UC
ulcerative colitis
WSAS
Work and Social Adjustment Scale
INTRODUCTION
Adverse events can occur in lower gastrointestinal (GI) endoscopy, including colonoscopy, flexible sigmoidoscopy, ileoscopy via stoma, and pouchoscopy. Therapeutic lower GI endoscopy carries a higher risk of the development of procedure-associated complications than diagnostic lower GI endoscopy. These complications can lead to additional adverse consequences (i.e., complication’s complications), such as admission to the intensive care unit, bowel resection, or mortality. In a National Inpatient Sample (NIS) study, elderly patients, Whites, inflammatory bowel disease (IBD), end-stage renal disease, and polypectomy were shown to be risk factors for colonoscopy-induced perforation in hospitalized patients. Common indications for colorectal surgery are IBD, colorectal cancer (CRC), and diverticular diseases. Colorectal surgeries have some of the highest complication rates in the surgical field. In addition to cardiopulmonary complications and anastomotic complications, urinary, sexual, and defecatory dysfunction can also occur, resulting mainly from sympathetic and parasympathetic nerve damage during mobilization and resection of the sigmoid colon and rectum. There are scant data on the impact of these procedure-associated complications on the quality of life (QoL) or mental health in the literature.
The assessment of comorbidities before and after endoscopy and surgery and after complications is important for the preparation, planning, and management. A variety of instruments are used for the assessment of comorbidity, severity of procedure-associated complications, QoL, and mental health which have been applied to lower GI endoscopy and colorectal surgery.
CLASSIFICATION OF ADVERSE EVENTS OF ENDOSCOPY AND SURGERY
Conscious sedation, monitored anesthesiology care, or general anesthesia are commonly used before endoscopy or surgery. The American Society of Anesthesiologists (ASA) is routinely used for the assessment of disease and comorbidities ranging from ASA Class I to IV. In addition, the Charlson Comorbidity Index (CCI) is also used to evaluate comorbidities. , The severity of surgical complications has been measured by the Clavien-Dindo Complication Classification (CDCD), ranging from Grade I to Grade V.
From an endoscopy perspective, the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) have published a series of guidelines on adverse events of GI endoscopy. The ASGE and UESG classifications are based on the type of endoscopy (upper or lower GI), and the frequency, location, and nature of complications. For colonoscopy, the ASGE guidelines listed the following categories: cardiopulmonary complications, perforation, hemorrhage, postpolypectomy electrocoagulation syndrome, infection, gas explosion, abdominal pain or discomfort, mortality, and miscellaneous complications. Complications from special endoscopic procedures (such as colonic dilation stent placement and foreign body removal) are described.
Modified from the Clavien-Dindo classification, the adverse events in gastrointestinal endoscopy (AGREE) classification was proposed. The AGREE classification consists of no adverse event; Grade I—adverse events with any deviation of the standard postprocedural course, without the need for pharmacological treatment or endoscopic, radiological, or surgical interventions (presentation at the emergency ward, without any intervention or hospital admission <24 hours, without any intervention, or allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, and electrolytes or allowed diagnostic tests: radiology and laboratory tests; Grade II—adverse events requiring pharmacological treatment with drugs other than those allowed for Grade I adverse events or blood or blood product transfusions or hospital admission >24 hours; Grade III—adverse events requiring endoscopic, radiologic, or surgical intervention; Grade IIIa—endoscopic or radiologic intervention; Grade IIIb—surgical intervention; Grade IV—adverse events requiring intensive care unit/critical care unit admission; Grade IVa—single-organ dysfunction; Grade IVb—multiorgan dysfunction; and Grade V—death of patient.
QUALITY OF LIFE AND MENTAL HEALTH SCORES
Quality of life has become a part of the outcome measurement of endoscopic and surgical therapy for IBD and colorectal disease along with the treatment of other disorders. Multiple instruments have been developed for the measurement of QoL before and after endoscopic or surgical therapy from different perspectives. For example, the Inflammatory Bowel Disease Questionnaire (IBDQ) is used in adult patients with IBD. The IBDQ-32 captures the patient’s experience of IBD in four domains: bowel symptoms; systemic symptoms; emotional function; and social function, with a 32 items and 7-point scale with 1 indicating the highest symptom frequency/severity and 7 indicating the lowest symptom frequency/severity. The 10-item Short Inflammatory Bowel Disease Questionnaire (SIBDQ). The 3-item Cleveland Global Quality of Life (CGQL) score or the Fazio score was initially proposed to measure health-related QoL in patients with restorative proctocolectomy (RPC) and ileal pouch-anal anastomosis (IPAA). CGQL consists of the current quality of life (0–10 points), the current quality of health (0–10 points), and the current energy level (0–10 points) with a total score of 30. The total score is then divided by 30, giving a range of final scores from 1 to 10 with 10 being the best. Functional bowel diseases can occur concomitantly with IBD or colorectal disease or after surgery. For example, irritable pouch syndrome (IPS) is common in patients with RPC and IPAA. To characterize the disease and assess outcomes, irritable bowel syndrome-quality of life (IBS-QOL) has been used in patients with IPS. ,
One of the commonly used tools to assess QoL in patients with cancer is the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30). Various subtypes of EORTC were proposed. The EORTC-C30 consists of the physical, role, emotional, cognitive, and functional domains. The European Organization for Research and Treatment of Cancer (EORTC QLQ-CR38) was specifically designed for CRC, which consists of four functional scales (body image, future perspective, sexual function, and sexual enjoyment) and eight symptom scales (micturition, GI disorders, defecation, stoma-related and sexual problems, nausea and vomiting, and weight loss). The scores have been used to assess QoL in patients undergoing colorectal surgery as a part of outcomes and the adverse impact of postoperative complications.
Various scores have been used to measure the mental health of patients before and after endoscopy and surgery in colorectal diseases. These instruments include the Center for Epidemiological Studies-Depression (CES-D), State-Trait Anxiety Inventory (STAI), and Medical Outcomes Study 36-item Short Form 36 (SF-36) questionnaires. In addition, the World Health Organization quality of life assessment instrument (short version, WHOQOL-BREF) is the short version of the WHOQOL-100 and has 24 questions in four domains (physical health, psychological health, social relationships, and environment) and two questions belonging to the general evaluative facet. The Depression, Anxiety, and Stress Scale (DASS-21) provides a self-report measure of anxiety and depression with maximum discrimination between the two scales. The DASS-21 is a 21-item version that was shown to be a reliable and valid measure of depression, anxiety, and tension/stress in clinical and nonclinical populations of adults and different cultural and ethnic groups. The Work and Social Adjustment Scale (WSAS) is a valid five-item self-report scale of functional impairment in the areas of work, home, and personal activities, attributable to an identifiable health problem. WSAS scores above 20 tend to suggest moderately severe or worse interference. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology. Scores below 10 appear to be associated with subclinical populations. The brief COPE scale is a 28-item (14 scales of 2 items each) measure to assess 14 conceptually differentiable coping reactions. There are scant published data on mental health instruments in endoscopic or surgical complications.
MENTAL HEALTH IN PATIENTS UNDERLYING ENDOSCOPY OR SURGERY
Complications can occur in any lower GI endoscopy and colorectal surgery. Bleeding and perforation are the main endoscopy-associated complications, while anastomotic leaks (AL) after colorectal resections for CRC are a leading cause of postoperative morbidity, long length of stay (LOS), and mortality. Both endoscopy and surgery are invasive, creating anxiety in patients. Mental health issues exist before and after endoscopy or surgery and persist even more in case of “unfavorable” diagnosis or procedure-associated complications occur. Anxiety is common in patients undergoing diagnostic and therapeutic colonoscopies. A meta-analysis of 58 studies involving 24,490 patients undergoing colonoscopy or flexible sigmoidoscopy with some using the STAI scale showed the mean anxiety level higher than that in the general population. In a study of 218 patients undergoing colorectal surgery, the surgery significantly increased depressive symptoms and anxiety levels. A total of 130 (59.6%) had complications. Severely complicated postoperative course adversely affected health status, most notably at 6 weeks postoperatively with the largest effects in the physical-, mental-, social-, and vitality domains in CES-D, STAI, and SF-36 scores. Education and teaching may help relieve preprocedural anxiety. For example, patients’ use of Web-based preparation instruction and video was shown to reduce procedural worry.
Patients with underlying mental health issues may have a higher risk for the development of colectomy-associated mental or physical complications than those without. In a study of 292,191 patients undergoing colon and rectal surgery from the Nationwide Inpatient Sample (NIS), a preoperative diagnosis of depression was present in 20,039 (6.9%) patients. The presence of a preoperative diagnosis of depression is associated with a prolonged hospital stay (10.4 days; 95% confidence interval [CI]: 10.04–10.76) as compared with those without depression (9.64 days; 95% CI: 9.48–9.81). In a separate study of 4,212,125 patients undergoing colorectal resection surgery from NIS, depression diagnosis was present in 6.72% of patients with colectomy and 6.54% of patients with proctectomy. Patients with a depression diagnosis who underwent colectomies had an increased risk of delirium (OR = 2.11; 95% CI: 1.93–2.32), wound infection (OR = 1.08; 95% CI: 1.03–1.12), urinary tract infection (OR 1.15; 95% CI: 1.10–1.20), paralytic ileus (OR =1.06; 95% CI: 1.03–1.09), and AL (OR = 1.37; 95% CI: 1.30–1.43). Similar findings were reported in those with proctectomy. In a study of 88,981 patients from the United States of The IBM MarketScan Research Databases (2010–2017) undergoing colectomy for main indications of CRC, IBD, or diverticular diseases, 21,878 (24.6%) had a history of depression. Multivariable analysis showed that patients with a history of depression had significantly longer LOS (incidence rate ratio [IRR] = 1.06; 95% CI: 1.05, 1.07), increased inpatient charge (β = 467, 95% CI: 167, 767), and increased odds of in-hospital mortality (OR = 1.37; 95% CI: 1.08, 1.73) respiratory complication (IRR = 1.18; 95% CI: 1.09, 1.27), pneumonia (IRR = 1.16; 95% CI: 1.05, 1.29), and delirium (IRR = 1.90; 95% CI: 1.52, 2.37).
IMPACT OF ENDOSCOPY AND SURGERY AND THEIR COMPLICATIONS ON QUALITY OF LIFE AND MENTAL HEALTH STATUS
While the measurement of QoL has become an integral part of surgical outcomes, it is not routine clinical practice in lower GI endoscopy in IBD or CRC. The endoscopy community may learn from surgeon colleagues. To incorporate QoL scores into daily clinical practice, the instrument should be simple, responsive, and easy to use. The classic example is Dr. Victor Fazio’s colorectal surgery group at the Cleveland Clinic in which CGQL is integrated into routine pre- and postoperative care. There is a good correlation between the simple, three-item CGQL and the more complicated Crohn’s Disease Activity Index and SF-36. , Therefore, CGQL is amenable to routine clinical practice. Unfortunately, there is limited literature on the impact of procedure-associated complications on patients’ mental health status.
Inflammatory Bowel Disease
The calculation of QoL scores has become popular in IBD surgery. A study of 37 patients with CD who underwent elective laparoscopic or open ileocecal resection with primary anastomosis showed significantly lower mean Gastrointestinal Quality of Life Index scores and mean SF-36 physical component scores than the general US population. In a prospectively maintained database cohort of 3707 consecutive patients undergoing RPC and IPAA mainly for UC or familial adenomatous polyposis), the median CGQL cohort measuring quality of life (range 0–10), quality of health (range 0–10), and quality of energy (range 0–10) at 1, 5, and 10 years for the whole cohort was 7–10. Furthermore, the impact of postoperative infectious complications on the QoL undergoing RPC and IPAA was also reported by the group. In a study of prospectively collected 200 (6.2%) with pelvic septic complications (<3 months postoperative) out of a 3234-case cohort of RPC and IPAA, the median overall CGQL (along with subscores) was significantly worse than in the sepsis group than the nonsepsis group (0.74 vs. 0.79, P < .001).
The author’s team has performed a series of studies of inflammatory and functional complications of the ileal pouch on QoL. QoL scores were measured by using CGQL (range 0–1, with 1 being the best QoL score), the IBS-QOL (range 34–170, with 170 being the worst QoL score), and the SIBDQ (range 0–70, with 70 being the best QoL score). Patients with pouchitis, CD of the pouch, cuffitis, or IPS were shown to have CGQL and SF-36 scores. Patients with diseased IPAA had worse QoL scores. Patients with CD of the pouch, either inflammatory, fibrostenotic, or penetrating phenotypes, all adversely affected QoL. Our group also surveyed 157 consecutive and responded patients with pouchitis, CD of the pouch, cuffitis, IPS, as well as asymptomatic patients with IPAA CGQL, IBS-QOL, WSAS, coping mechanisms (brief COPE), and DASS-21. Patients with IPS were more likely to be taking antidepressants, anxiolytics, or narcotics than the other groups ( P < .04). Patients with inflammatory disorders of the pouch or IPS had poorer quality of life (CGQL, P < .001; IBS-QOL, P < .003) (particularly in differences in food avoidance, activity interference, and sexual difficulties) and greater impairment in the domains of daily functioning related to the pouch condition than those with asymptomatic pouches. The mean depression symptom scores were significantly higher in the IPS group than in the normal pouch group (11.7 ± 9.7 vs. 4.4 ± 6.2; P = .012). Patients with structural complications of IPAA refractory to medical endoscopy therapy may benefit from pouch redo surgery. Patients undergoing transabdominal redo surgery 502 (43% males) for various structural or inflammatory complications from index IPAA. The median CGQL score after redo pouch surgery is 0.7 (range 0–1).
Worldwide, the incidence and prevalence of IBD are increasing, leading to a growing number of patients with surgery. RPC and IPAA are increasingly performed in developing countries. IPAA-associated complications are common. In a recent case series of 58 patients with UC, RPC, and IPAA, 25 (43.1%) developed early surgical complications and had a median follow-up time of 78.5 months (interquartile range [IQR], 34.4–92.8). While the CGQL score was significantly increased after IPAA (0.728 ± 0.151 vs. 0.429 ± 0.173, P < .001) compared to that before surgery, early surgical complications (OR, 5.55; 95% CI: 1.44–21.37) were found to be associated with poor long-term QoL.
Interventional IBD (i.e., endoscopic therapy in IBD) has emerged as a subspecialty of gastroenterology and IBD. The main treatment modalities of interventional IBD are endoscopic balloon dilation, endoscopic stricturotomy, endoscopic strictureplasty, endoscopic fistulotomy, endoscopic sinusotomy, endoscopic mucosectomy, and endoscopic submucosal dissection. These less invasive procedures have been shown to prevent or defer more invasive surgical intervention and reduce the risk of procedure-associated complications. However, QoL or change of mental health status was not integrated into outcome measures. Endoscopy-associated complications, particularly bowel perforation, can have detrimental medical and physical consequences. The impact of the endoscopy-complications on QoL and mental health warrant investigation.
Colorectal Cancer
The assessment of QoL is commonly practiced in colorectal surgery for CRC with or without chemoradiotherapy. Mental health issues were occasionally investigated too. QoL and mental health issues have been investigated in patients who developed postoperative complications.
Postoperative complications in CRC adversely impact patients’ QoL and mental health. A prospective data-based controlled study of 864 patients undergoing restorative resection for rectal cancer was performed to assess Short-Form 36 (physical and mental component scales) and the Fecal Incontinence Severity Index. AL was found in 52 (6%) patients. Patients with AL had worse physical and mental component scores of SF-36 than non-AL controls (N = 812). A questionnaire study (EORTC QLQ-C30 and C38) of 121 patients with rectal cancer undergoing low anterior resection (LAR) with or without stoma or J-pouch (N = 96) or abdominoperineal resection (APR, N = 25) showed that 33 (27.3%) patients reported severe postoperative complications in a median follow-up of 36 months. Postoperative complications include CDCC Grade I in 11 (9.1%), CDCC Grade II in 15 (12.4%), CDCC Grade III in 28 (23.1%), and CDCC Grade IV in 5 (4.1%) A univariable analysis showed patients with severe postoperative complications had a lower mean score on physical functioning (73 vs. 85, P = .031) and higher mean scores on pain (17 vs. 0, P = .025) and fatigue (33 vs. 22, P = .036) than those without. Of eligible 614 patients undergoing the laparoscopic-assisted vs. open surgery for CRC (CLASICC) trial, complications occurred in 215 (35.0%), including wound complications in 61 (9.9%), chest infection in 50 (8.1%), AL in 27 (4.4%), hemorrhage in 14 (2.3%). There were significant long-term differences in QoL between patients with and without complications, as measured by physical and social function, role functioning, and body image on EORTC QLQ-C30/QLQ-CR38 analysis. In a small case series (N = 12) with postoperative complications (anastomotic leakage, abdominal bleeding, abdominal wall sepsis, wound infection) requiring salvage surgery after index surgery for CRC EORTC QLQ-C30) and disease-specific (EORTC QLQ-CR29) quality of life and treatment satisfaction (EORTC IN-PATSAT32) were measured. The patients reported a worse score of physical function, emotional function, and anxiety than patients without such complications 1 month postoperative and worse scores in general satisfaction with the quality of care and surgeons’ interpersonal and technical skills, providing information, and availability than those without such complications. The presence of postoperative psychiatric complications and anastomotic leakage were independent predictors of QoL. A case-controlled study of 25 patients with AL (CDCC Grade II, n = 14, and Grade III, n = 11) after LAR for rectal cancer and 50 patients with LAR but no complications were performed with SF-36, Gastrointestinal Quality of Life Index, EORTC-C30, and EORTC-CR29. The AL group had a longer LOA and a higher risk for stoma than the controls. In addition, the patients in the AL group had worse physical, emotional, and social function and overall QoL scores than controls. In a prospective cohort study of the WHOQOL-BREF questionnaires in 218 patients with colorectal surgery, 130 (59.6%) had complications with minor complications (CDCC Grade I–II) in 73 (33.5%) and severe complications (CDCC Grade III–V) in 57 (26.1%). Patients with severe complications had a greater decrease in overall QoL ( P = .043), QoL-physical ( P < .001), and QoL-psychological ( P = .013) domains in the first six postoperative weeks than those with minor complications. A meta-analysis of 13 studies focusing on the AL after sphincter preserving rectal cancer surgery, QoL such as physical and emotional function difficulties may persist up to 3 years after the development of AL.
The impact of demographic features, mental health, and CRC may be mutual. Individuals with severe mental illness have a greater risk of dying from CRC. However, there is a disparity of care received in patients with CRC. A systematic review and meta-analysis of 10 studies showed patients with severe mental illness (including psychotic and affective disorders) and CRC had a reduced likelihood of surgery (risk ratio [RR] = 0.90, 95% CI: 0.92–0.97; P = .005). A study of a prospective database of 115 (33%) older (≥70 years) patients with CRC and 230 (67%) younger (<70 years) patients undergoing radiotherapy showed that the former group had more often short-course radiation with delayed surgery and more likely had a Hartmann procedure with permanent stoma than the latter. The presence of postoperative complications had a more severe impact on physical and role functioning (but not on global health, social function, cognitive function, or emotional function, in the older patients than their younger counterparts, while the patients with both groups had a comparable risk of overall postoperative complications and surgical complications (such as AL, abscess, wound-related issues, ileus, and bleeding).
Endoscopic therapy for colorectal neoplasia has evolved from polypectomy to endoscopic mucosal resection, endoscopic submucosal dissection, and endoscopic full-thickness resection. In addition, the spectrum of interventional IBD has been expanded to other colorectal diseases, particularly in the management of anastomotic complications following colectomy for CRC or other benign colorectal diseases. For example, endoscopic balloon dilation and electroincision are routinely performed in patients with anastomotic strictures at Columbia University Irving Medical Center/NewYork Presbyterian Hospital. We also routinely perform endoscopic sinusotomy to treat presacral sinus from LAR. Despite their efficacy and safety profile, procedure-associated complications can occur. We plan to incorporate QoL scores and mental health scores into our daily practice to measure the outcomes of endoscopic therapy and the physical, mental, social, and economic effects of procedure-associated complications.
SUMMARY AND RECOMMENDATIONS
A variant of QoL and mental health instruments is developed and used in the medical, endoscopic, and surgical treatment of IBD, CRC, and other colorectal diseases. Current literature in QoL and mental health in colorectal disease is mainly focused on the outcome of medical therapy and postoperative applications. With the progression of corrective endoscopy and surgery in colorectal diseases, the measurement of QoL and mental health status should be integrated into quality and outcome measurements. One of the best examples of routine application of QoL is the Cleveland Global Quality of Life in the RPC and ileal pouch-anastomosis. Complications are common in endoscopy (particularly therapeutic endoscopy) and surgery (particularly in obese patients or those with radiation therapy) for colorectal surgery. The severity of endoscopy or surgery-associated complications is classified with the common use of the Clavien-Dindo Complication Classification and its variants. More studies are needed to incorporate QoL and mental health scores in corrective endoscopy and corrective surgery.
REFERENCES
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