Status:

COMPLETED

Healing of Rectal Anastomosis Sealed With a Concentrate Derived From the Patient's Blood, After Rectal Cancer Surgery

Lead Sponsor:

University of Aarhus

Collaborating Sponsors:

Danish Cancer Society

Conditions:

Anastomotic Leak Rectum

Rectal Cancer

Eligibility:

All Genders

18+ years

Brief Summary

Rectal cancer is one of the most frequent cancer diseases, with more than 1500 new cases per year in Denmark. Fortunately, if the tumor is discovered early, surgeons can remove the part of the intesti...

Eligibility Criteria

Inclusion

  • Primary rectal cancer (adenocarcinoma) with the lower boarder within 15 cm from the anal verge assessed by rigid proctoscopy
  • Clinical UICC stage I-III at time of rectal cancer diagnosis
  • Deemed suitable for intended curative rectal cancer resection at MDT either by total mesorectal excision (TME) or partial mesorectal excision (PME)
  • Scheduled for elective, minimal invasive surgery
  • ECOG performance status 0-2
  • Age at least 18 years
  • Written and orally informed consent

Exclusion

  • Distant metastatic disease
  • Locally advanced rectal cancer requiring extended resection
  • Open surgery
  • Benign lesions of the rectum
  • Inflammatory bowel disease
  • Another malignant disease within previous 2 years
  • Inability and unwillingness to give informed consent
  • Pregnant (positive pregnancy test) or breast feeding women

Key Trial Info

Start Date :

December 15 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 8 2023

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT05293054

Start Date

December 15 2021

End Date

November 8 2023

Last Update

March 27 2024

Active Locations (1)

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1

Department of Surgery, Aarhus University Hospital

Aarhus, Central Jutland, Denmark, 8200