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

Rectal Cancer Clinical Trial

— ISRECLeak  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06059924
• Other study ID #: ISREC leakage rectal resection
• Status: Completed
• Start date: February 1, 1991
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 941
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital of St. Gallen	Saint-Gall

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-specific survival		30 days postoperative to 5 years postoperative
Secondary	Overall survival		30 days postoperative to 5 years postoperative
Secondary	Disease-free survival		30 days postoperative to 5 years postoperative
Secondary	Recurrence-free survival		30 days postoperative to 5 years postoperative