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Completed

NCT Number: NCT06059924

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastomotic leakage

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.

Primary outcomes

  1. Cancer-specific survival

    Time frame: 30 days postoperative to 5 years postoperative

Secondary outcomes

  1. Overall survival

    Time frame: 30 days postoperative to 5 years postoperative

  2. Disease-free survival

    Time frame: 30 days postoperative to 5 years postoperative

  3. Recurrence-free survival

    Time frame: 30 days postoperative to 5 years postoperative

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

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

Acronym: ISRECLeak

Important dates

Study start
1991
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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