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Does the Management of Anastomotic Leakage After Low Rectal Resection Affect Survival

Does the Management of Anastomotic Leakage After Low Rectal Resection Affect the Long-term Oncological Outcome: A Retrospective Propensity Score Adjusted Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06059924
Acronym
ISRECLeak
Enrollment
941
Registered
2023-09-29
Start date
1991-02-01
Completion date
2020-12-31
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Rectal Cancer

Keywords

Rectal cancer, Low rectal resection, Anastomotic leakage, ISREC-classification, Cancer-specific survival, Propensity score

Brief summary

The aim of this retrospective cohort-study is to assess the effects of AL and its severity divided according the ISREC-classification on the long-term oncological outcome.

Detailed description

Rectal cancer is one of the most common malignancies in the world. Its costs and cancer-related mortality are increasing worldwide. The surgical treatment was revolutionized in recent years by the total mesorectal excision (TME) technique as well as the laparoscopic, robotic, and transanal approach. But anastomotic leakage (AL) remains one of the most feared complications after low rectal resection regarding postoperative morbidity and mortality as well as functional outcome. Several risk factors causing AL like low level of anastomosis, large tumor mass, male gender, smoking, perioperative bleeding, and preoperative radio-chemotherapy are known. Protective ileo- or colostomy formation and transanal tube placement may decrease the risk of AL and reduces the rate of reoperation due to AL. Diverting results of the association between AL and the long-term oncological outcome (local recurrence, systemic recurrence, survival) are described in the current literature. The International Study Group of Rectal Cancer (ISREC) provides a classification of AL according to its clinical management: * Grade A results in no change in patient's management * Grade B requires active therapeutic intervention without re-laparotomy * Grade C requires re-laparotomy This classification allows a good stratification regarding postoperative morbidity and mortality. However, the association between the ISREC-classification of AL and the long-term oncological outcome is not yet clear.

Interventions

OTHERAnastomotic leakage

Anastomotic leakage was defined as a defect of the intestinal wall at the anastomotic site leading to a communication between the intra- and extraluminal compartments. It was diagnosed by clinical, laboratory, radiological (ultrasound, endosonography, computed tomography), endoscopic, and/or surgical findings.

Sponsors

Cantonal Hospital of St. Gallen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients receiving elective low anterior resection (LAR) between February 1991 and December 2020 at the Cantonal Hospital of St. Gallen

Exclusion criteria

* Other diagnosis than rectal cancer * Discontinuity resection (no anastomosis) * Emergency situation * R1-resection * Incomplete staging * Metastatic cancer * 30-day mortality * Decline of a retrospective data analysis * Secondary malignancy * Age under 18 years

Design outcomes

Primary

MeasureTime frame
Cancer-specific survival30 days postoperative to 5 years postoperative

Secondary

MeasureTime frame
Overall survival30 days postoperative to 5 years postoperative
Disease-free survival30 days postoperative to 5 years postoperative
Recurrence-free survival30 days postoperative to 5 years postoperative

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026