SEARCHCOHORTcolorectal surgery, surgical oncology

cohort·colorectal surgery, surgical oncology, gastroenterology, general surgery·PMC10007828

Safety profile of a multimodal fail-safe model to minimize postoperative complications in oncologic colorectal resections—a cohort study

Perioperative Medicine · 6 authors, 2 centres

AI SUMMARY

FIDELITY 100%

POPULATIONPatients with colorectal cancer (UICC stage I–IV) undergoing surgical resection with primary anastomosis at a single German hospital (n=696; mean age 70.2 years; 53.9% male; 82.2% colon cancer, 17.8% rectal cancer)

INTERVENTIONMultimodal fail-safe perioperative protocol (2015–2019) including mechanical bowel preparation, perioperative single-dose IV antibiotics, on-table bowel irrigation, standardized tension-free anastomosis technique (side-to-side or end-to-end with specific technical steps), bleeding/perfusion testing at resection margin, intraoperative sigmoidoscopic assessment for rectal anastomoses, protective ileostomy for low rectal anastomoses, pelvic drain placement, early postoperative low-volume high-calorie nutrition, and endoscopic anastomosis assessment on postoperative day 4

COMPARISONHistorical control group (2013–2014) treated with ERAS protocol without structured fail-safe elements (no routine preoperative colonic irrigation, no routine perfusion testing, no routine ileostomy or on-table lavage for rectal resections)

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AGENT 01 · STRUCTURED SUMMARY

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TL;DR

This cohort study of 696 patients found that a multimodal fail-safe perioperative protocol for colorectal cancer resections significantly reduced major complications (Dindo-Clavien ≥3b) from 22.6% to 9.8% (p<0.0001) and anastomotic leakage from 11.8% to 3.7% (p<0.0001) compared to a historical control group. The protocol included standardized preoperative bowel preparation, single-dose antibiotics, tension-free anastomosis with perfusion testing, on-table bowel irrigation, early endoscopic assessment, and routine involvement of an experienced colorectal surgeon. These findings support adopting a structured, multidisciplinary fail-safe protocol to improve outcomes in oncologic colorectal surgery.

Full summary

4,520 CHARS

**Background:** Postoperative complications after colorectal surgery remain high, with reported rates from 20% to 60%, and there is no universally accepted standard perioperative protocol for colorectal cancer patients. While ERAS and fast-track surgery pathways have shown benefits, no single protocol comprehensively addresses pre-, peri-, and postoperative steps. This study evaluates a multimodal fail-safe model designed to minimize severe complications following oncologic colorectal resections.

**Methods:** This single-center study at Hospital Reinbek St. Adolf-Stift, Germany, compared a historical control group (January 2013–December 2014, n=186) with a prospectively collected fail-safe group (January 2015–December 2019, n=510). Inclusion required oncologic colorectal resection with primary anastomosis for UICC stage I–IV colorectal cancer. Exclusion criteria were benign lesions, terminal stoma, or associated malignancies. The fail-safe protocol included: preoperative mechanical bowel preparation without oral antibiotics; perioperative single-dose IV antibiotics; standardized surgical technique with an experienced colorectal surgeon (>30 resections with anastomosis/year) always present; complete mesocolic excision with central vascular ligation; complete mobilization of the hemicolon for tension-free anastomosis; bleeding/perfusion testing at the resection margin; side-to-side anastomosis with additional tension-relieving seams or end-to-end anastomosis with specific technical steps (sphincter stretching for 3 minutes, stapler spine positioned next to staple line, compression for ≥1 minute before release); intraoperative sigmoidoscopic assessment with air test for rectal anastomoses; protective ileostomy for all low rectal anastomoses; on-table lavage with 5L saline via efferent ileal loop; pelvic drain placement; 3-day low-volume high-calorie nutrition; and endoscopic anastomosis control on postoperative day 4. The control group was treated with ERAS without preoperative colonic irrigation, routine perfusion testing, routine ileostomy, or on-table lavage. Statistical analysis used chi-square test, t-test, and multivariate logistic regression (IBM SPSS v25).

**Key Results:** Of 924 patients undergoing colorectal operations, 696 met inclusion criteria (427 laparoscopic [61.4%], 230 open [33.0%], 39 conversions [5.6%]). Groups were comparable in age, sex, ASA classification, BMI, and tumor distribution, except for surgical approach (control: 51.6% open vs fail-safe: 26.3% open; p<0.0001). Major complications (Dindo-Clavien ≥3b) reduced from 22.6% (42/186) to 9.8% (50/510) (p<0.0001). Anastomotic leakage decreased from 11.8% (22/186) to 3.7% (19/510) (p<0.0001), with significant reduction in left colon (p=0.047) and low rectal resections (p<0.001), but not right colon (p=0.755). Re-operation rate fell from 18.8% to 6.1% (p<0.0001), wound infection from 18.3% to 5.3% (p<0.0001), and pneumonia from 6.5% to 2.5% (p=0.014). 90-day mortality was similar (2.7% vs 2.4%, p=0.80). Mean postoperative hospital stay was significantly shorter in the fail-safe group (8.9 vs 18.9 days, p<0.0001). Logistic regression confirmed significantly less leakage in the fail-safe group (p<0.000), with AL significantly associated with longer hospital stay (p<0.000), poor 90-day survival (p<0.05), surgical site infection (p<0.000), and re-operation (p<0.000).

**Clinical Implications:** This multimodal fail-safe protocol demonstrates substantial reductions in major complications, anastomotic leakage, re-operations, and wound infections compared to standard ERAS-based care. The comprehensive approach addresses modifiable risk factors across all perioperative phases, with particular benefit for high-risk low rectal anastomoses (AL rate 1.2% for elective cases). Key elements include mandatory experienced surgeon involvement, standardized anastomotic technique with perfusion testing, routine protective ileostomy for low rectal anastomoses, on-table lavage, early endoscopic surveillance, and OTSC-ready management of detected leaks. The protocol is applicable in both elective and emergency settings. Limitations include non-randomized design, single-center setting, larger fail-safe group, potential confounding from laparoscopic technique improvements over time, and inability to determine the independent contribution of each protocol component. Further research is needed to validate individual elements and incorporate emerging technologies like ICG fluorescence imaging.

PICO

PPOPULATION

Patients with colorectal cancer (UICC stage I–IV) undergoing surgical resection with primary anastomosis at a single German hospital (n=696; mean age 70.2 years; 53.9% male; 82.2% colon cancer, 17.8% rectal cancer)

IINTERVENTION

Multimodal fail-safe perioperative protocol (2015–2019) including mechanical bowel preparation, perioperative single-dose IV antibiotics, on-table bowel irrigation, standardized tension-free anastomosis technique (side-to-side or end-to-end with specific technical steps), bleeding/perfusion testing at resection margin, intraoperative sigmoidoscopic assessment for rectal anastomoses, protective ileostomy for low rectal anastomoses, pelvic drain placement, early postoperative low-volume high-calorie nutrition, and endoscopic anastomosis assessment on postoperative day 4

OOUTCOME

Major complications (Dindo-Clavien grade IIIb–V): 9.8% vs 22.6% (p<0.0001); anastomotic leakage: 3.7% vs 11.8% (p<0.0001); re-operation rate: 6.1% vs 18.8% (p<0.0001); wound infection: 5.3% vs 18.3% (p<0.0001); pneumonia: 2.5% vs 6.5% (p=0.014); 90-day mortality: 2.4% vs 2.7% (p=0.80); mean postoperative hospital stay: 8.9 days vs 18.9 days (p<0.0001)

STUDY TYPE

cohort

SPECIALTY

colorectal surgery

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10007828

Safety profile of a multimodal fail-safe model to minimize postoperative complications in oncologic colorectal resections—a cohort study

Perioperative Medicine

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ABSTRACT

Background Despite innovations in surgical techniques, major complications following colorectal surgery still lead to a significant morbidity and mortality. There is no standard protocol for perioperative management of patients with colorectal cancer. This study evaluates the effectiveness of a multimodal fail-safe model in minimizing severe surgical complications following colorectal resections. Methods We compared major complications in patients with colorectal cancers who underwent surgical resections with anastomosis during 2013–2014 (control group) with patients treated during 2015–2019 (fail-safe group). The fail-safe group had preoperative bowel preparation and a perioperative single dose of antibiotics, on-table bowel irrigation and early sigmoidoscopic assessment of anastomosis in rectal resections. A standard surgical technique for tension-free anastomosis was adapted in the fail-safe approach. The chi-square test measured relationships between categorical variables, t -test estimated the probability of differences, and the multivariate regression analysis determined the linear correlation among independent and dependent variables. Results A total of 924 patients underwent colorectal operations during the study period; however, 696 patients had surgical resections with primary anastomoses. There were 427 (61.4%) laparoscopic and 230 (33.0%) open operations, while 39 (5.6%) laparoscopic procedures were converted. Overall, the rate of major complications (Dindo-Clavien grade IIIb–V) significantly reduced from 22.6% for the control group to 9.8% for the fail-safe group ( p < 0.0001). Major complications mainly occurred due to non-surgical reasons such as pneumonia, heart failure, or renal dysfunction. The rates of anastomotic leakage (AL) were 11.8% (22/186) and 3.7% ( n = 19/510) for the control and fail-safe groups, respectively ( p < 0.0001). Conclusion We report an effective multimodal fail-safe protocol for colorectal cancer during the pre-, peri-, and postoperative period. The fail-safe model showed less postoperative complications even for low rectal anastomosis. This approach can be adapted as a structured protocol during the perioperative care of patients for colorectal surgery. Trial registration This study was registered in the German Clinical Trial Register (Study ID: DRKS00023804 ).

CITATION EXPORT

Shahram Khadem, Jonas Herzberg, Human Honarpisheh et al.. Safety profile of a multimodal fail-safe model to minimize postoperative complications in oncologic colorectal resections—a cohort study. Perioperative Medicine. (2023). https://doi.org/10.1186/s13741-023-00291-6

AUTHORS

6 · 2 CENTRES

Shahram Khadem, Jonas Herzberg, Human Honarpisheh, Robert Maximilian Jenner, Salman Yousuf Guraya, Tim Strate

1Department of Surgery, Krankenhaus Reinbek St. Adolf-Stift, Hamburger Strasse 41, 21465 Reinbek, Germany
2grid.412789.10000 0004 4686 5317Clinical Sciences Department, College of Medicine, University of Sharjah, P. O. Box 27272, Sharjah, United Arab Emirates