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Multicenter Study
. 2020 Jan;99(2):e18560.
doi: 10.1097/MD.0000000000018560.

The problem of colorectal anastomosis safety

Marius Kryzauskas  1 , Eligijus Poskus, Audrius Dulskas, Augustinas Bausys, Matas Jakubauskas, Ugne Imbrasaite, Gabija Makunaite, Justas Kuliavas, Rimantas Bausys, Eugenijus Stratilatovas, Kestutis Strupas, Tomas Poskus
Affiliations
Multicenter Study

The problem of colorectal anastomosis safety

Marius Kryzauskas et al. Medicine (Baltimore). 2020 Jan.

Abstract

Introduction: Anastomotic leakage (AL) remains one of the most threatening complications in colorectal surgery with the incidence of up to 20%. The aim of the study is to evaluate the safety and feasibility of novel - trimodal intraoperative colorectal anastomosis testing technique.

Methods and analysis: This multi-center prospective cohort pilot study will include patients undergoing colorectal anastomosis formation below 15 cm from the anal verge. Trimodal anastomosis testing will include testing for blood supply by ICG fluorescence trans-abdominally and trans-anally, testing of mechanical integrity of anastomosis by air-leak and methylene blue leak tests and testing for tension. The primary outcome of the study will be AL rate at day 60. The secondary outcomes will include: the frequency of changed location of bowel resection; ileostomy rate; the rate of intraoperative AL; time, taken to perform trimodal anastomosis testing; postoperative morbidity and mortality; quality of life.

Discussion: Trimodal testing of colorectal anastomosis may be a novel and comprehensive way to investigate colorectal anastomosis and to reveal insufficient blood supply and integrity defects intraoperatively. Thus, prevention of these two most common causes of AL may lead to decreased rate of leakage.

Study registration: Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03958500, May, 2019.

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Conflict of interest statement

We declare that this study is funded by Vilnius University. The individual data of the patients will remain confidential. The results of this study may be presented at national and international conferences and published. The study is a part of doctoral thesis of M.K. at the Faculty of Medicine Vilnius University. The proctoscope and an additional laparoscopic system with near-infrared fluorescence imaging camera were provided without pay by Karl Storz, Germany. No other financial support was received by any of the authors. All the authors declare that they have no additional conflict of interest.

Figures

Figure 1
Figure 1
Detailed flowchart of the study.
See this image and copyright information in PMC

References

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