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

NCT ID: NCT06059924

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 941 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1991-02-01
• Study Completion Date: 2020-12-31

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.

Conditions

Rectal Cancer; Anastomotic Leak

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

leak

Patients with diagnosed anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III

Anastomotic leakage

Intervention Type: OTHER

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.

noleak

Patients without anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III

No interventions assigned to this group

Interventions

Anastomotic 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Ignazio Tarantino

Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignazio Tarantino, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Chirurgie, Cantonal Hospital of St. Gallen

Locations

Cantonal Hospital of St. Gallen

Sankt Gallen, , Switzerland

Countries

Switzerland

References

Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.

Reference Type: BACKGROUND

PMID: 20004450 (View on PubMed)

Other Identifiers

ISREC leakage rectal resection

Identifier Type: -

Identifier Source: org_study_id