Use of Sodium Hyaluronate/Carboxymethylcellulose Bioresorbable Membrane in Loop Ileostomy Construction Facilitates Stoma Closure

INTRODUCTION

The creation of a loop ileostomy is often a necessary adjunct to surgical procedures for low rectal cancers and inflammatory bowel disease. Several authors have advocated temporary fecal diversion to reduce clinically significant anastomotic dehiscence and to ameliorate the septic consequences of leakage from low pelvic bowel anastomosis.1-6 After a variable time interval and assessment of anastomotic integrity by water-soluble contrast enema, intestinal continuity can typically be restored with mobilization of the ileostomy through a limited peristomal incision. In our practice, closure of loop ileostomies is typically performed 5-8 weeks after the index operation for patients who are not undergoing postoperative chemotherapy. Dissection through a limited incision may be impaired due to adhesion formation at or below the fascial level, resulting in longer operating times and an increased potential for bowel injury.

We have adopted a technique of wrapping the loop of small intestine with an antiadhesion barrier film—sodium hyaluronate/carboxymethylcellulose (SH/CMC) bioresorbable membrane—before its delivery through the abdominal wall for stoma maturation. As SH/CMC has been demonstrated in previous studies to reduce postoperative adhesion development, we hypothesized that the use of SH/CMC would significantly decrease the operating time necessary for ileostomy closure with no effect on infectious complications or other patient morbidities.7-9

RESULTS

During the 12-year observation period, 293 patients underwent creation and closure of a loop ileostomy: 146 had an SH/CMC wrap placed at the time of ileostomy creation (Group 1), and 147 ileostomies were created without SH/CMC placement (Group 2). No significant differences were found between the 2 groups in age, sex, the time interval between creation and closure of ileostomy, or primary diagnosis (Table 1).

The average operating time for ileostomy closure was significantly shorter for patients in Group 1 (46.4 ± 2.7 minutes) compared to Group 2 (60.0 ± 2.3 minutes) (P=0.0001). Our data showed no statistical difference in mean length of stay after stoma closure for either group: 4.6 ± 0.2 days in Group 1 vs 4.9 ± 0.2 days in Group 2 (P=0.38).

We found no difference in wound infection at the stoma site adjusted for BMI with or without the use of SH/CMC (Table 2). Group 1 had 8 infections (5.5%) vs 10 infections in Group 2 (6.8%) (P=0.62). No increase in other complications including ileus, bleeding, anastomotic leak, or stoma site hernia occurred with the use of SH/CMC (P=0.3).

DISCUSSION

The results of our analysis prove our hypothesis that the use of the SH/CMC wrapping technique results in significantly shorter operative times for closure of loop ileostomies with no increase in perioperative complications. Shorter operative times are an objective outcome that may serve as a surrogate marker of adhesion formation and operative difficulty. An easier operation is especially important when working with small peristomal incisions and surgical trainees.

In contrast to previous studies, our study is based on results from a single group of board-certified colon and rectal surgeons who use relatively uniform techniques for ileostomy creation, SH/CMC placement, and ileostomy closure.

In a 2003 study, Tang et al randomized patients into 2 treatment groups (ileostomy creation with and without placement of SH/CMC at the ileostomy site).10 In phase I of the trial, patients with SH/CMC-wrapped ileostomies (n=51) were assessed by water-soluble enema for ileostomy reversal 3 weeks after the index operation, while ostomies created without SH/CMC wraps (n=54) were assessed after 6-12 weeks. Phase II of the trial was designed with assessment of both treatment groups for ileostomy closure 3 weeks postoperatively. The mean 4-quadrant adhesion scores, as assessed by the surgeon at the time of ileostomy closure, were significantly lower for ileostomies created with an adhesion barrier (SH/CMC). The adhesion barrier patient group also had significantly lower perioperative complications. However, Tang et al found no difference in operative time with the use of SH/CMC.

In a 2006 multicenter, randomized trial, Salum et al evaluated adhesion grade, operative time, and postoperative complications.11 Patients from 15 institutions were prospectively randomized into 3 groups: Group 1 had placement of SH/CMC around the ostomy and midline, Group 2 had SH/CMC placed under the midline only, and Group 3 had no SH/CMC placement. The adhesion grade at the time of ileostomy closure was significantly lower for patients in Group 1 compared to Group 3; however, lower adhesion grade did not translate into a significant difference in operative time.

In a 2012 publication, Memon et al in Australia performed a case-matched study that showed SH/CMC wrapping of ileostomies could facilitate early stoma closure.12 Thirty-two patients selected for early closure protocol were retrospectively matched with patients who had conventional closure. The early closure protocol included wrapping the ileostomy in SH/CMC and a planned closure at 4-6 weeks if contrast enema showed no evidence of leak. Ultimately, 22 patients had early closure with a median closure at 55 days compared to 213 days in the conventional group (P<0.001). No differences in complications or length of stay were seen between the 2 groups.

Our study has several limitations. Because of the retrospective design, we could not evaluate the effect of SH/CMC placement on adhesion grade, which is a subjective assessment made by the operating surgeon at the time of ileostomy closure. Our surgeons all felt the operation was easier with SH/CMC; however, this subjective statement is not supported by any method of objective measurement. Also, our groups were not randomized, so some bias in terms of which surgeons used the SH/CMC wrapping technique could be present. The lack of statistical difference when each individual surgeon's experience was analyzed most likely reflects the small sample size for each surgeon and is a type II error. The lack of statistical significance in a subset analysis of the neoplasm group was also a type II error.

The mean interval between creation and closure of 92.7 days for Group 1 and 109.6 days for Group 2 is typical of our practice. The majority of the surgeons in this practice close the ileostomy in patients with cancer after completion of postoperative chemotherapy (usually approximately 6 months). When looking at the model, we found that the mean interval between surgeries was 58 days for Group 1 and 63 days for Group 2, reflecting the practice of closing the ileostomy in patients not receiving postoperative chemotherapy at 5-8 weeks.

While a formal cost analysis was not performed, the cost of one sheet of SH/CMC is approximately $150, and the cost of operating room time at our institution is approximately $80-$100 per minute. Thus, the use of SH/CMC potentially saves $1,088 to $1,360 per case.

CONCLUSION

Based on our experience, the use of an antiadhesion product has become standard practice when creating our diverting ileostomies. Not only did we find a significant difference in operating time with the use of SH/CMC (14 minutes faster overall), but our surgeons all felt that the ileostomy closure was easier when they used SH/CMC. Since the completion of this study, the use of SH/CMC has become standard practice at our institution. While a randomized controlled trial that includes evaluation of adhesion grades would be ideal and give further credence to our hypothesis, given the significant difference in operating times with the use of SH/CMC without increased morbidity, we feel that such a study would add very little. However, questions remain as to the cost effectiveness of SH/CMC in other surgical procedures, and further studies are indicated.