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

Completed

• Conditions: Anastomotic Leak; Rectal Cancer
• Interventions: Other: Anastomotic leakage

• Registration Number: NCT06059924
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Study Timeline

• Study Start: 1991-02-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-09
• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 941

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
leak	Anastomotic leakage	Patients with diagnosed anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III

Primary Outcome Measures

Name	Time	Method
Cancer-specific survival	30 days postoperative to 5 years postoperative

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	30 days postoperative to 5 years postoperative
Recurrence-free survival	30 days postoperative to 5 years postoperative
Overall survival	30 days postoperative to 5 years postoperative

Trial Locations

Locations (1)

Cantonal Hospital of St. Gallen; 🇨🇭 Saint-Gall, Switzerland