UnknownNot Applicable

Objective Perfusion Rate Assessment by Near-infrared Fluorescence in Ileal Pouch Formation and Ileal-pouch-anal Anastomosis

Germany50 participantsStarted 2019-02-01

Plain-language summary

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. Postoperatively, a detailed software-based assessment of each pouch recording is performed to determine the objective ICG-NIRF perfusion rate, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * age ≥ 18 * capability of signing the informed consent * diagnosis of therapy resistent ulcerative colitis, colorectal cancer, Crohn's disease, familial adenomatous polyposis * restorative proctocolectomy (RPC) with reconstruction through ileal pouch formation and ileal pouch-anal anastomosis (IPAA) is possible and medically indicated * ASA (American Society of Anesthesiologists) Physical Status Classification System score ≤ 3 Exclusion Criteria: * coexistent malignant tumor of a different ethology * liver disfunction (MELD score \> 10) * ICG (indocyanine green) specific exclusion criteria as per literature (intolerance to indocyanine green or sodium iodide, iodine allergy, hyperthyroidism, autonomous thyroid adenoma, focal or diffuse autonomies of the thyroid, previously badly tolerated injection of ICG) * pregnancy or breastfeeding

What they're measuring

anastomotic leak

Timeframe: 30 days

Trial details

NCT IDNCT04695964

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01

Contact for this trial

Benjamin Weixler, PD MD

+49 30 450 622 798 benjamin.weixler@charite.de