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

NCT06059924 | Completed

• 1 other identifier: ISREC leakage rectal resection
• Study Type: observational
• Target: 941
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Anastomotic Leak

Keywords

Rectal cancer; Low rectal resection; Anastomotic leakage; ISREC-classification; Cancer-specific survival; Propensity score

Outcome Measures

Primary Outcomes (1)

• Cancer-specific survival

  30 days postoperative to 5 years postoperative

Secondary Outcomes (3)

• 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

Study Arms (2)

leak

Patients with diagnosed anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III

Other: Anastomotic leakage

noleak

Patients without anastomotic leakage after low rectal resection for rectal cancer UICC stage I to III

Interventions

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.

leak

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated at the Cantonal Hospital of St. Gallen

You may qualify if:

• Patients receiving elective low anterior resection (LAR) between February 1991 and December 2020 at the Cantonal Hospital of St. Gallen

You may not qualify if:

• Other diagnosis than rectal cancer
• Discontinuity resection (no anastomosis)
• Emergency situation
• R1-resection
• Incomplete staging
• Metastatic cancer
• day mortality
• Decline of a retrospective data analysis
• Secondary malignancy
• Age under 18 years

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Cantonal Hospital of St. Gallen

Sankt Gallen, 9000, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 20004450 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ignazio Tarantino, PD Dr. med.

  Klinik für Chirurgie, Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 29, 2023
• Study Start: February 1, 1991
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)