Preventing Parastomal Hernia Using a Modified Sugarbaker Technique With Composite Mesh During Laparoscopic Abdominoperineal Resection

A Randomized Controlled Trial

Manuel López-Cano, MD; Xavier Serra-Aracil, MD; Laura Mora, MD; José Luis Sánchez-García, MD; Luis Miguel Jiménez-Gómez, MD; Marc Martí, MD; Francesc Vallribera, MD; Domenico Fraccalvieri, MD; Anna Serracant, MD; Esther Kreisler, MD; Sebastiano Biondo, MD; Eloy Espín, MD; Salvador Navarro-Soto, MD; Manuel Armengol-Carrasco, MD

Disclosures

Annals of Surgery. 2016;264(6):923-928. 

In This Article

Results

During a 24-month recruitment period, 85 patients with cancer of the lower third of the rectum were assessed for eligibility. Twenty-nine patients were excluded from the study because of lack of fulfillment of the inclusion criteria (n = 24) and refusal to take part in the study (n = 5). Therefore, 56 patients were randomized, 28 to the mesh group and 28 to the control group. Four patients in the mesh group were excluded from the final analysis for the following reasons: technical difficulties prevented the mesh to be inserted (n = 1), a low anterior resection with colorectal anastomosis and ileostomy instead of an APR was performed (n = 1), conversion to open surgery (n = 1), and the procedure was cancelled for anesthetic problems (n = 1). The per-protocol analysis was therefore applied to 52 patients, 24 in the mesh group and 28 in the control group. The flow chart of the study participants is shown in Fig. 1. The clinical follow-up lasted a median of 26 months (interquartile range (IQR): 12 mnths, range 13 to 38 mnths).

Figure 1.

Flow chart of the study participants.

Table 1 summarizes the clinical characteristics of patients in the 2 groups. No statistically significant differences were observed between the groups for demographic variables, risk factors for PH, or Charlson morbidity index.

Postoperative mortality in the 2 groups was 0. The overall postoperative morbidity was higher in the mesh group than in the control group, but differences regarding postoperative ileus, cancer stage, neo-adjuvant or adjuvant therapies, distance from the anal verge of the tumors, and type of APR were not statistically significant. Surgical time and length of stay was similar in the 2 groups. During the immediate postoperative period, partial dehiscence of the colostomy was recorded in 2 patients from the mesh group but without significant differences as compared with the control group (P = 0.21). No patient presented prolapsed colostomy. Parastomal cellulitis due to chronic mesh infection did not occur. Throughout the follow-up period, no signs of mesh intolerance were recorded in any of the patients. No patient required reintervention due to rejection of the mesh (Table 2).

After CT examination, 6 of 24 PHs (25%) were observed in the mesh group compared with 18 of 28 (64.3%) in the nonmesh group (odds ratio 0.39, 95% CI 0.18–0.82; P = 0.005). Type of PH according to the CT classification is summarized in Table 3. At follow-up, surgery was necessary in 1 patient from the mesh group due to symptomatic PH at 1 year after the initial operation.

Four patients died in the mesh group at 18, 23, 29, and 38 months after intervention. The first three died as a consequence of the progression of their cancer and the fourth due to exacerbation of their chronic heart failure. Three patients in the mesh group died at 22, 36, and 38 months, respectively, the first and second patient due to progression of their cancer, and the third due to chronic respiratory insufficiency.

Figure 2 shows the Kaplan-Meier curves for PH identified using CT. The comparison of the curves showed significant differences in favor of the mesh group (long-rank = 4.21, P = 0.04).

Figure 2.

Kaplan-Meier curve for the appearance of PH detected by CT scan.

The NNT was 2.5, that is, on average, 2.5 patients had to receive the experimental treatment (mesh) instead of control treatment (no mesh) for 1 additional patient not to have the study outcome.

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