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

September 22, 2023 updated by: Ignazio Tarantino, Cantonal Hospital of St. Gallen

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 30 days postoperative to 5 years postoperative
30 days postoperative to 5 years postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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