Self-assembling peptide haemostatic gel reduces incidence of pelvic collection after total mesorectal excision: Prospective cohort study.

BACKGROUND: Pelvic surgery has the potential to leave behind a large raw surface, which can bleed and ooze postoperatively. The adoption of precision surgical approach for rectal cancers has led to reduction in blood loss. We aimed to assess 1) the feasibility and 2) the safety of using a self-assembling peptide (SAP) haemostatic agent (PuraStat®) after rectal cancer surgery to reduce the incidence of pelvic collections. MATERIALS AND METHODS: This prospective cohort pilot study compared the results of 25 consecutive cases of total mesorectal excision (TME) with use of 5-10 ml of SAP, and 25 consecutive cases without PuraStat® application (CON, control group). The groups were compared for complications (Clavien-Dindo grade III and IV classification), postoperative drain output and length of hospital stay (LOS). Statistical analysis was carried out using paired samples T test and Fisher's exact test. RESULTS: Fifty patients (SAP = 25, CON = 25) were enrolled into this study. Mean drain outputs (ml) on day 1, day 2 and day 3 were 60 ± 18, 89 ± 42 and 64 ± 45 in SAP group, and 102 ± 31, 95 ± 52, 66 ± 37 in CON group. This was significantly better for SAP group in day one after surgery. The mean LOS was shorter in SAP group (5.7 versus 7.4 days in CON, p 0.04). Clavien-Dindo III & IV complications were seen in two and five cases respectively (p 0.18). R0 resection rate (p 0.32) and lymph node harvest (p 0.13) were similar in both groups. There were no complications seen in relation to the application of the SAP. CONCLUSIONS: These initial data suggest that SAP is a safe product, and feasible to apply in the pelvis after TME surgery. It appears to shorten the LOS and reduce the postoperative drain output and may reduce the incidence of Clavien-Dindo grade III & IV complications.