RecruitingNCT07099820

Role of Indexed Oxygen Delivery in Anastomotic Insufficiencies in Elective Laparoscopic Colorectal Resections for Cancer

Role of Indexed Oxygen Delivery in Anastomotic Insufficiencies in Elective Laparoscopic Colorectal Resections for Cancer: a Prospective Observational Cohort Study


Sponsor

Saint Camillus International University of Health Sciences

Enrollment

100 participants

Start Date

Sep 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Colorectal cancer is a very commonly diagnosed malignancy worldwide, and surgical resection remains the mainstay of treatment. Outcomes depend on preoperative staging, surgical quality, complication rates, and multidisciplinary care; minimally invasive techniques have reduced local and systemic complications. However, anastomotic dehiscence (AD) remains the most significant local complication. AD is a breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments. Mortality rates vary from 1.7% to 29%. Reduced oxygen delivery-pre-, intra-, or post-operatively-can contribute to AD, while adequate oxygenation improves healing. Supplemental O₂ (FiO₂ 80%) has been shown to reduce AD risk after gastric surgery. Tissue oxygen delivery can be quantified by indexed oxygen delivery (DO2I), defined as ml/min/m² and determined by cardiac output, hemoglobin, and saturation. Pulse cardiac output (CO)-Oximeter® (Masimo), allow continuous non-invasive monitoring of these parameters. This prospective observational cohort study aims to explore the correlation between intraoperative DO2I and the risk of postoperative anastomotic dehiscence, using the non-invasive technologies described.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether monitoring a specific blood oxygen delivery measurement during planned bowel surgery for cancer can predict whether the surgical join (anastomosis) will leak afterward — a serious complication. Researchers hope the findings will lead to safer surgery for colon and rectal cancer patients. **You may be eligible if...** - You are 18 or older - You are scheduled for planned (elective) minimally invasive (laparoscopic) colorectal surgery for cancer, with a bowel reconnection - Your surgery involves joining parts of the bowel (ileo-colic, colo-colic, or colo-rectal connection) **You may NOT be eligible if...** - You are under 18 - You are unable to give informed consent - Your surgery is an emergency - You are having open (laparotomy) surgery rather than keyhole surgery - You are having a bowel bag (stoma) created rather than a reconnection - You have a condition like Raynaud's disease that affects blood flow to the fingers (which interferes with the monitoring device) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

St. Eugenio Hospital

Rome, Italy

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NCT07099820


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