The Interguard® group was composed of all the patients undergoing colorectal surgery and temporary loop ileostomy between May 2019 and July 2020. The control group consisted of patients who were undergoing exploratory lapartomy either laparoscopic or conventional open colorectal surgery for the second time where no adhesion barrior was added during the first surgery. All of the patients in control group had their first surgery in Gachon Medical Center. All the clinical data were collected prospectively and approved by the clinical research ethics committee of the Gachon University, Gil Medical Center. Written informed consent was obtained from all patients according to the policies of the committee (IRB# GIRBB2019-090) and was registered at Clinical Research Information Service, CRIS(https://cris.nih.go.kr/cris) identifier: KCT0005062. Any information that could identify the patients was not included in this article. All methods were performed in accordance with the Helsinki guidelines and regulations.
Operative procedure
Single colorectal surgeons participated in this study. These surgeons followed the standard procedures for colectomy and protectomy with lymph node dissection and anastomoses. For the sigmoid, rectosigmoid and rectal surgeries, Interguard® was placed over the pelvic inlet where the peritoneum was denuded, due to pelvic dissection, before closure of the abdomen, as described by Park et al [13]. A direct contact with adhesion barrier and anastomoses was avoided. Temporary ileostomy was made and Interguard® was wrapped around the loop intraabdominally before ileostomy maturation. At the time of temporary ileostomy closure, a laparoscopic approach was used to take pictures of four abdominal quardrant to asscess adhesion grade proposed by Nair et al[14]. These 4 quadrant pictures (right upper, right lower, left upper and left lower quadrant) were immediately sent to a single radiologist for adhesion grade scoring. Each quadrant was graded accordingly (Appendix Table 1 and Fig. 1). None of the patients underwent an emergency operation for peritonitis or cancer obstruction.
Table 1
| Interguard group | Control group | P value |
Number | 14 | 24 | |
Mean age | 61 | 64 | 0.221 |
Gender M:F | 10:4 | 11:13 | 0.116 |
Comorbidity | 14 | 24 | 0.528 |
Weight (Kg) ± SD | 62.3 ± 11.4 | 65.3 ± 18.0 | 0.577 |
Height (cm) ± SD | 162.2 ± 8.7 | 161.6 ± 9.4 | 0.851 |
Previous abdominal Surgery | 0 | 0 | - |
SD: standard deviation |
Data collection
The age, gender, body weight, height, medical history, a history of abdominal surgery for second operated patients were recorded at the time of admission to the hospital. The following postoperative parameters were documented: the type of operation, perioperative complications such as intra-abdominal abscess, anastomotic site leakage, peritonitis, early postoperative intestinal obstruction, and the perioperative mortality. In addition, laboratory tests (a complete blood cell count and the levels of aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen and serum creatinine) were performed on postoperative day 5. The patients were followed their initial discharge. All patients were followed up at outpatient department two to three weeks after the surgery. All patients were educated to revisit the clinic if they developed any of the symptoms such as abdominal pain/distension or failure to pass the gas. Any adverse events and concomitant medications were assessed.
The primary end point of this study was the adhesion grade at the time of temporary ileostomy takedown in Interguard® group and adhesion grade at the time of second laparotomy for the control group. The adhesion grade and postoperative blood chemistry was compared between the two groups.
Statistical analysis
Using two proportions power analysis, a sample size was calculated. The differences in continuous variables were analyzed with the Student t test. For the categorical variables, the differences were analyzed with the χ2 test. The given probability values are two-sided; P values less than 0.05 were considered to indicate statistical significance.