Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Stefan S

PROVIDER: S-EPMC8376673 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMinimally invasive total mesorectal excision (MiTME) and transanal total mesorectal excision (TaTME) are popular trends in mid and low rectal cancer. However, there is currently no systematic comparison between MiTME and TaTME of mid and low-rectal cancer. Therefore, we systematically study the perioperative and pathological outcomes of MiTME and TaTME in mid and low rectal cancer.MethodsWe have searched the Embase, Cochrane Library, PubMed, Medline, and Web of Science for articles on MiTME (robotic or laparoscopic total mesorectal excision) and TaTME (transanal total mesorectal excision). We calculated pooled standard mean difference (SMD), relative risk (RR), and 95% confidence intervals (CIs). The protocol for this review has been registered on PROSPERO (CRD42022374141).ResultsThere are 11010 patients including 39 articles. Compared with TaTME, patients who underwent MiTME had no statistical difference in operation time (SMD -0.14; CI -0.31 to 0.33; I2=84.7%, P=0.116), estimated blood loss (SMD 0.05; CI -0.05 to 0.14; I2=48%, P=0.338), postoperative hospital stay (RR 0.08; CI -0.07 to 0.22; I2=0%, P=0.308), over complications (RR 0.98; CI 0.88 to 1.08; I2=25.4%, P=0.644), intraoperative complications (RR 0.94; CI 0.69 to 1.29; I2=31.1%, P=0.712), postoperative complications (RR 0.98; CI 0.87 to 1.11; I2=16.1%, P=0.789), anastomotic stenosis (RR 0.85; CI 0.73 to 0.98; I2=7.4%, P=0.564), wound infection (RR 1.08; CI 0.65 to 1.81; I2=1.9%, P=0.755), circumferential resection margin (RR 1.10; CI 0.91 to 1.34; I2=0%, P=0.322), distal resection margin (RR 1.49; CI 0.73 to 3.05; I2=0%, P=0.272), major low anterior resection syndrome (RR 0.93; CI 0.79 to 1.10; I2=0%, P=0.386), lymph node yield (SMD 0.06; CI -0.04 to 0.17; I2=39.6%, P=0.249), 2-year DFS rate (RR 0.99; CI 0.88 to 1.11; I2=0%, P = 0.816), 2-year OS rate (RR 1.00; CI 0.90 to 1.11; I2=0%, P = 0.969), distant metastasis rate (RR 0.47; CI 0.17 to 1.29; I2=0%, P = 0.143), and local recurrence rate (RR 1.49; CI 0.75 to 2.97; I2=0%, P = 0.250). However, patients who underwent MiTME had fewer anastomotic leak rates (SMD -0.38; CI -0.59 to -0.17; I2=19.0%, P<0.0001).ConclusionThis study comprehensively and systematically evaluated the safety and efficacy of MiTME and TaTME in the treatment of mid to low-rectal cancer through meta-analysis. There is no difference between the two except for patients with MiTME who have a lower anastomotic leakage rate, which provides some evidence-based reference for clinical practice. Of course, in the future, more scientific and rigorous conclusions need to be drawn from multi-center RCT research.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO, identifier CRD42022374141.