Survey Regarding Gastrointestinal Stoma Construction and Closure in Japan

Abstract Background and Aim In Japan, the actual number of stoma constructions and stoma closures is not known. The aim of this study was to conduct a survey to determine the number of gastrointestinal stoma constructions and closures in Japan. Methods Enrolled participants comprised patients undergoing selected gastrointestinal surgeries who were recorded in the National Clinical Database. This database uses the “Common Items for Gastrointestinal Surgeons.” These procedures were formulated by the Japanese Society of Gastroenterological Surgery during 2013–2018. Results According to the National Clinical Database, a total of 154,323 gastrointestinal stomas were constructed between January 1, 2013 and December 31, 2018. By procedure, there were 78,723 cases of stoma construction, 39,653 of abdominoperineal resection, 2470 total pelvic exenteration procedures, and 33,572 Hartmann's procedures. The ratio of stoma closures to stoma constructions increased annually in patients under 70 y of age but not in older patients. Approximately 35% of total colectomies, 60% of proctocolectomies, and 20% of low anterior resections were accompanied by stoma construction. The number of patients with rectal cancer who underwent colostomy increased gradually during the study period and the number who underwent stoma construction increased among older patients. Conclusion The number of cases of gastrointestinal stoma construction has increased gradually in Japan, and the proportion of older patients is increasing each year. The purposes and surgical techniques for stoma construction are diverse and are expected to increase in Japan, a super‐aged society.


| INTRODUC TI ON
Ostomates need to learn new skills after surgery and overcome many challenges so as to return to a normal social life, because defecation management after the construction of a gastrointestinal stoma requires special skills. 1-3 In Japan, it is estimated that there are currently approximately 210,000 people who have received physical disability certificates, which can be applied for after the installation of a permanent stoma. 4 However, the number of temporary stomas and the number of stoma closures cannot be ascertained in the same way, and there are no data available to clearly ascertain the number of new gastrointestinal stomas and the number of people who have them. Additionally, patient background information, such as basic information and surgical information, has not been collected. Thus, it is difficult to grasp the actual situation regarding the number of constructed stomas and stoma closures, together with the patient backgrounds, according to the current official statistics. It is therefore unclear how many ostomates actually exist in Japan at present and the background under which their stoma was constructed. To plan specific support measures for ostomates in Japan, which is a super-aged society unparalleled in the world in terms of its medical care technology and social security system, 5  and approximately 1,500,000 cases are registered every year. 6,7 In a validation study using 2016 data conducted by the gastroenterological section of the NCD, the Japanese Society of Gastroenterological Surgery (JSGS), patient demographics, surgical outcomes, and processes were proven to be highly institutionalized. 8,9 Therefore, by extracting cases of gastrointestinal stoma construction and closure from the NCD database, the number of gastrointestinal stomas constructed and their co-procedures, the percentage of stomas constructed among them, and the patient background including age group and preoperative information, can be used to confirm the actual situation of gastrointestinal stoma construction in Japan. At the same time, the number of gastrointestinal stoma closures can serve as a valuable dataset to predict the number of people with temporary stomas. In the present study, we conducted a survey regarding the number of gastrointestinal stoma constructions and closures in Japan.

| PARTI CIPANTS AND ME THODS
The enrolled participants were patients who underwent selected gastrointestinal surgical procedures and who had surgical data recorded in the NCD. The NCD uses the "Common Items for Gastrointestinal Surgeons" as defined in the "Training Curriculum for Board Certified Surgeons in Gastroenterology." These procedures were formulated by the JSGS. The study period covered 2013-2018, and the data were extracted according to the conditions related to the construction of gastrointestinal stoma.

| Surgical procedure
The total number of cases of gastrointestinal stoma was classified into four categories: abdominoperineal resection (APR), total pelvic exenteration (TPE), Hartmann's procedure, and stoma construction. Stoma construction includes enterostomy and colostomy. To exclude "colostomy" as a route for nutritional injection, cases of concurrent gastric and esophageal surgery were excluded. The total number of stomas was defined as the total number of stomas in the four categories.
For enterostomy and colostomy, those associated with esophageal and gastric surgeries were excluded. In cases of total colectomy, proctocolectomy and ileoanal anastomosis, and low anterior resection (LAR), patients without a record of a concomitant procedure were counted separately from stoma nonconstruction. Stoma closure included enterostoma closure, colostoma closure, and stoma closure.

| Statistical analysis
Descriptive statistics were conducted for the number of procedures performed, by sex and age group, during 2013-2018 for stoma construction (except for APR, TPE, and Hartmann's procedure), APR, TPE, and Hartmann's procedure. The total number of cases of stoma construction and stoma closure was also analyzed by sex and age group over time. Additionally, the number of patients with and without stoma construction, patients' sex, and patients' age group were counted for the three techniques of total colectomy, proctocolectomy and ileoanal anastomosis, and LAR, and changes over time were examined. In malignant neoplasms of the rectum (International Classification of Diseases, Tenth Revision code: C20), the following

| Annual changes in stoma construction and closure by sex and age group
In total, there were 77,910 cases of stoma closure during the study period, with 26,804 cases among women and 51,106 among men. In a comparison by sex, as with colostomy, there were more men than women under 85 y of age and more women than men over 85 y of age. The ratio of stoma closure to stoma construction by age group in  Table S1).

| Number of stoma and nonstoma constructions, according to surgical technique, by sex and age group
The number of total colectomies was 7788 (in 3182 women and 4606 men). Among them, 5090 cases (2073 women, 65.14%; 3017 men, 65.50%) were nonstoma construction and 2698 cases (1109 women, 1589 men) were stoma construction. Surgery with nonstoma construction in both sexes was performed in ~55% of patients under 60 y of age and 70%-75% in those over 70 y of age.
The total number of patients with proctocolectomy and ileoanal anastomosis was 2470 (924 women and 1546 men). Among them, 1018 cases (380 women and 638 men, 41.13% and 41.27%, respectively) were nonstoma construction and 1452 cases (544 women and 908 men) were stoma construction. As with total colectomy, surgery with nonstoma construction in both sexes was performed in ~40% of patients under 60 y of age and in 30%-50% of patients over 60 y of age. Although there was no difference between men and women, there were 1875 patients under the age of 60 y, accounting for 76% of the total.  Figure 3, Table S2). Table 2 shows the characteristics of LAR with stoma construction, The rate of stage T4b was 2.65% for LAR without diverting stoma and 3.86% for diverting stoma. The APR rate was 9.07%, Hartmann's technique 12.9%, and stoma construction without bowel resection 36.79%. Hartmann's procedure was characterized by a higher percentage of ASA-PS 4 and 5 (5.9%) compared with other procedures, with fewer than 1% for LAR and 1.41% for APR (Table 2).

| Patient characteristics with malignant and benign tumors in LAR
The characteristics of each malignant neoplasm and benign tumor in LAR are shown in Table 3

| D ISCUSS I ON
In this study we found that the number of cases of stoma construction in Japan has been increasing slowly, and the number of these patients in their 70s and older has been increasing each year. This finding may be due to the fact that some older patients Because all of these surgeries are combined with anastomosis of the intestine with preservation of the anus, we considered that this type of stoma construction is positioned as a diverting stoma.
In the 1990s and 2000s, it was reported that temporary stoma placement significantly prevented suture failure in low anterior resection. [13][14][15][16][17][18] Later, in the 2010s, the impact of temporary stoma construction on rates of complication other than suture failure was also examined. 14 Insurance coverage for stents beginning in 2012 has enabled preoperative decompression for colorectal cancer obstruction, decreased the rate of stoma construction before cancer chemotherapy, 19 and has reportedly prevented suture failure in transanal anal drains. 20 Robot-assisted surgery has also been reported to have a higher rate of stoma construction than non-robot-assisted surgery. 25 In Japan, robotic-assisted surgery in the lower rectum has been covered by the national health insurance since 2018. Therefore, future studies should consider robotic-assisted surgery and other types of surgery. Thus, it is expected that the indications for diverting stoma will be transformed with the evolution of surgical instruments, equipment, and techniques.
In rectal cancer, APR, Hartmann's procedure, and stoma construction are characterized by stage progression, as compared with low anterior resection. In particular, Hartmann's procedure has a closure rate of 46% 27 owing to bowel perforation or malignant obstruction as an emergency surgery, suggesting a background of a poor general condition.
Although there are reports that the presence or absence of concomitant stoma construction in LAR is related to age, low albumin, tumor size, distance from the anus, and rectal pressure, 26 the results of the present study showed that the prevalence of preoperative chemotherapy and radiation therapy is a decisionmaking factor for stoma construction specific to malignant disease.
Surgery for rectal cancer, a typical disease for which a gastrointestinal stoma is placed, can range from APR to LAR to preserve the anus and can require the placement of a permanent stoma, a temporary stoma, or no stoma. 13 In particular, the rate of stoma construction following curative surgery for rectal cancer is decreasing owing to advances in anuspreserving surgical equipment and techniques. 28 However, the number of stomas is expected to increase in the future, given the increase in the number of patients with rectal cancer and surgeries. 6 33 and stoma construction as a countermeasure for complications of other diseases and treatments are also increasing, 34 because the period to resection surgery can be longer than that for stenting. 35 Additionally, stoma construction surgeries are F I G U R E 3 Number of stoma construction and no-construction according to the three colorectum operative procedures by sex and age group TA B L E 2 Patient characteristics for stoma and nonstoma construction according to surgical procedures for rectal cancer (ICD-10 code C20, malignant neoplasms of the rectum) also performed for benign diseases, such as emergency surgery for colonic perforation. 36,37 Thus, it is necessary to consider that the purpose and indications for stoma construction will change and to look at the future trends. In Japan, where the proportion of older people is the highest in the world, the low ratio of stoma closure in the oldest patients in this study and the indications for stoma construction in older people (8) suggest that the number of gastrointestinal ostomates, especially in super-aged populations, will continue to increase in the future.

| Limitations
In this survey, the background for the construction of a gastrointestinal stoma could not be clarified because it was not linked to the name of the disease in the data source used. Additionally, multiple terms are used to refer to surgical procedures used to create a gastrointestinal stoma, such as "colostomy," which includes enterocutaneous fistula for the purpose of creating an excretion route and enterocutaneous fistula for a route of nutrition injection. Because the purpose of this survey was to determine the route of excretion, we excluded those procedures that were performed in conjunction with esophageal surgery so as to exclude those performed for nutritional infusion.   10,000-14,400 per year. The number of stoma closures has also increased. The ratio of concomitant stoma construction surgery was higher in older people, and the ratio of stoma closure was higher in younger patients. The purposes and surgical techniques of stoma construction are diverse and are expected to increase in Japan, which is a super-aged society.

ACK N OWLED G M ENTS
This study was adopted as a new research proposal in the field of gastrointestinal surgery in 2019 by the Japanese Society of Gastroenterological Surgery National Clinical Database (NCD) data utilization study, and was then conducted. We thank all the data managers and hospitals participating in this NCD project for their efforts in entering the data. We thank Analisa Avila, MPH, ELS, of Edanz (https://jp.edanz.com/ac) for editing a draft of this article.