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

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Anastomotic Leak
• Intervention / Treatment: Other: Anastomotic leakage

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 Type: Observational
• Enrollment (Actual): 941

Contacts and Locations

Study Locations

• Switzerland
  • Saint-Gall, Switzerland, 9000
    • Cantonal Hospital of St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients operated at the Cantonal Hospital of St. Gallen

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
leak; Patients with diagnosed anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III	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.
noleak; Patients without anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cancer-specific survival	30 days postoperative to 5 years postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	30 days postoperative to 5 years postoperative
Disease-free survival	30 days postoperative to 5 years postoperative
Recurrence-free survival	30 days postoperative to 5 years postoperative

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Ignazio Tarantino, PD Dr. med., Klinik für Chirurgie, Cantonal Hospital of St. Gallen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 1991
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rectal cancer; Anastomotic leakage; Low rectal resection; ISREC-classification; Cancer-specific survival; Propensity score
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anastomotic Leak
• Other Study ID Numbers: ISREC leakage rectal resection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No