Clinical trial NCT06059924: Does the Management of Anastomotic Leakage After Low Rectal Resection Affect Survival
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Anastomotic Leak
Keywords: Rectal cancer
Low rectal resection
Anastomotic leakage
ISREC-classification
Cancer-specific survival
Propensity score
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 941
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated at the 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer-specific survival
timeFrame: 30 days postoperative to 5 years postoperative
Secondary outcomes:
measure: Overall survival
timeFrame: 30 days postoperative to 5 years postoperative
measure: Disease-free survival
timeFrame: 30 days postoperative to 5 years postoperative
measure: Recurrence-free survival
timeFrame: 30 days postoperative to 5 years postoperative
Other outcomes:
Locations:
city: Saint-Gall
country: Switzerland
facility: Cantonal Hospital of St. Gallen
Study officials:
affiliation: Klinik für Chirurgie, Cantonal Hospital of St. Gallen
name: Ignazio Tarantino, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.