Patients and enrollment. A retrospective study including consecutive patients who underwent ileostomy closure between January 2015 and June 2016 at the Hanyang University Hospital, Seoul, Republic of Korea, was conducted. Data from patients with stage IV colorectal cancer, patients older than 85 years, and patients who experienced intestinal perforation during the procedure were excluded. Reasons for exclusion were as follows: patients with stage IV colorectal cancer were excluded because they could not attend regular follow-up visits in the clinic, patients older than 85 years were excluded because advanced age is a risk factor for incisional hernia, and patients who experienced intestinal perforation during the procedure were excluded because of possible wound contamination. General surgical consent for the use of mesh was obtained from all patients. This study was approved by the Institutional Review Board of Hanyang University Medical Center (IRB No. 2018-12-032).
Surgical procedures. Two (2) surgeons performed an equal number of surgeries using the same surgical approach. Prophylactic preoperative intravenous antibiotics were administrated at induction of anesthesia. The proximal loop was sutured using a purse-string stitch with 2-0 black silk to prevent leakage of the ileal content onto the surgical field during the procedure. A trephine incision was made after the skin around the ileostomy site was prepared. The ileal anastomosis was performed using sutures or stapling devices according to the surgeon’s preference. The tissue plane just superficial to the aponeurosis surrounding the fascial closure was dissected. The decision to use biologic mesh was based on the surgeons’ preference. In all cases, the fascia and soft tissue were cultured for microbiological organisms, and Jackson-Pratt wound drains were inserted between the skin flap and the fascia. Skin closure was performed using a 2-0 polypropylene (Prolene, Ethicon) interrupted suture.
The fascia was closed by continuous suture using 1-0 polyglyconate copolymer sutures (Maxson, Covidien) in the primary closure group. The drain was removed when the output was less than 20 mL/day for 2 consecutive days in the primary closure group.
If it was determined that a biologic mesh was going to be used, a 2 x 3 cm or 4 x 7 cm non-crosslinked porcine dermal biologic mesh (XCM Biologic Tissue Matrix, Johnson & Johnson Medical) was selected according to the size of the fascial defect in the mesh closure group. The mesh was placed anterior to the rectus sheath onlay. Transfascial bites were
anchored using 2-0 polydioxanone (PDS, Ethicon) sutures taken circumferentially (Figure 1). The drain was removed on postoperative days (PODs) 2 or 3 regardless of the amount of output in the mesh closure group because the mesh was water-permeable. For 3 to 5 days, a compressive dressing was applied to facilitate healing between the skin flap and the fascia and mesh in the mesh closure group.
Study endpoints and definitions. The primary endpoint of the study was the safety of the biologic mesh defined as the need for mesh removal due to mesh-related infectious complication. Secondary endpoints included SSI, incisional hernia, and wound pain. The definition of the SSI followed the Centers for Disease Control and Prevention Guidelines,14 which state that SSI is an infection that occurs within 30 days after the operative procedure if no implant is left in place or within 1 year if an implant is in place and the infection appears to be related to the operative procedure. Surgical site occurrence (SSO) was defined as surgical site seroma and hematoma. The presence of an incisional hernia was determined by physical examination and imaging studies. To determine the presence of hernia, physical examination was performed in both the standing and supine positions for all patients by assessing increased abdominal pressure using the Valsalva maneuver. On physical examination, the hernia was defined as bulging during the Valsalva maneuver and by palpation of the fascial defect. Morbidity was classified using the Clavien-Dindo system15; of most relevance to this study, Clavien-Dindo grade III was defined as a complication that required surgical, endoscopic, or radiological intervention.
White blood cell (WBC) counts and C-reactive protein (CRP) levels were measured on PODs 1, 3, and 5. A visual analog scale (VAS) was used for pain evaluation. VAS scores were measured on PODs 1, 3, 5, and 14.
Follow-up and data collection. Clinical follow-up was undertaken in the hospital outpatient clinics of the respective surgeons. Patients visited the outpatient clinic 2 weeks, 1 month, and 6 months after stoma reversal. In addition, patients underwent computed tomography (CT) scans every 6 months during the follow-up period.
The authors collected the data by reviewing electronic medical records. In addition to the outcome variables, abstracted data included demographics (eg, age, sex, body mass index [BMI], underlying disease) and surgical data (type of index operation, purpose of index operation, surgical approach of index operation, operation time, and length of hospital stay). Index operation was defined as the operation at the time of the creation of the ileostomy. Patients were categorized as using additional analgesics if they were administered acetaminophen, nonsteroidal anti-inflammatory drugs, or narcotic analgesics, even once during hospitalization, intravenously.
Statistical analysis. The statistical data were coded electronic medical records to SPSS by manual entry. Continuous variables were presented as mean ± standard deviation. Categorical variables were presented as frequency (%). Clinical and surgical variables were compared using the Mann-Whitney U test, the χ2-test, or Fisher’s exact test, depending on the nature of the data. A P value < .05 was considered statistically significant. Statistical analyses were conducted with SPSS version 18.0 (SPSS Inc).