Patients. A retrospective study design was used to examine outcomes of consecutive patients who underwent colorectal surgery with stoma creation at the University of Tsukuba Hospital from 2015 to 2019. The clinical data were retrieved in 2020. The suturing method employed was historically changed as follows: AL-D suturing was performed from April 2015 to April of 2017, whereas SM-D suturing was performed from May 2017 to February 2019. The reason for this change was that SMS had occurred in several cases using the AL-D procedure; therefore, the authors attempted to modify the suturing method for better outcome. Both elective and emergency surgeries were included. The cases were intraoperatively supervised by Y. Ohara, T. Enomoto, and Y. Owada to ensure standardization of the surgical technique. These surgeons were educated on the protocol. Patients who underwent surgery by non–protocol-educated surgeons were excluded. This study was approved by the ethics committee of Tsukuba Clinical Research and Development Organization, University of Tsukuba Hospital. Informed consent for surgery was obtained from all patients.
Method of stoma creation. All patients, including those who underwent emergency surgery, had preoperative stoma site marking. After intestinal maneuver and/or resection, a round skin incision was made, followed by an appropriate aperture creation in the abdominal wall through the rectus muscle. A segment of the intestine was advanced through the abdominal wall and fixed there to keep a stomal height of 2 to 3 cm. The intestine was opened using electrocautery. Three-point suturing (skin, intestinal edge, and intestinal wall) was placed to attach the intestine to the abdominal wall, keeping stomal height (4–6 sutures). Two-point suturing (skin and intestinal edge) was performed to fix the mucocutaneous junction (12–16 sutures). Additional sutures were placed, depending on the stomal size. The differences in suturing procedures of AL-D and SM-D are shown in Figure 1. Briefly, in the AL-D suture, the needle is threaded through the full thickness (mucosa and seromuscularis) of the intestinal edge (Figure 1A). In contrast, in the SM-D suture, the needle is threaded only through the seromuscularis layer of the intestinal edge (Figure 1B). All sutures are buried sutures, that is, they did not go through the epidermis. Monofilament absorbable strings 4-0 (Monodiox; Alfresa Pharma, Osaka, Japan) were used.
Postoperative stomal care and evaluation of SMS. Stomal care was standardized by the surgeons and the Society of Wound, Ostomy, and Continence Nurses. High-quality photographs of the stoma were taken and collected in the record by the nurses at the time of stomal care. The primary outcome of the study was the occurrence and severity of SMS based on the medical records and photos.
Postoperative SMS severity was categorized into the following 3 grades by Y. Ohara according to SMS proportion: grade A (mild), grade B (moderate), and grade C (severe) (Figure 2). Grade A was defined as SMS less than a quarter of a circle, Grade B as SMS between a quarter to half of a circle, and Grade C as SMS more than half of a circle. SMS was surveyed during the patients’ hospital stay as the focus of the study was on the early complications of stoma creation.
Clinical data collection. All clinical data were collected from the electronic medical records of the University of Tsukuba Hospital. The abstracted variables included patient demographics (age, sex, body mass index), surgical and medical history (reason for surgery, emergency or planned procedure, stoma type, history of chemotherapy, radiation therapy, steroid use, diabetes mellitus, and length of hospital stay), and occurrence and extent of SMS.
Statistics. Statistical analyses were performed as descriptive statistics using the chi-square test with Fisher’s exact test, and univariate or multivariate analysis by multiple logistic regression analysis using IBM SPSS Statistics Version 25 (IBM Japan, Tokyo). Differences at P < .05 were considered statistically significant. All factors included in the multivariate analysis were selected if the P value in the univariate analysis was P < .3.