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

NCT07099820 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Anastomosis; Complications
  • Anastomosis, Surgical
  • Anastomosis, Leaking
  • Anastomotic Leaks
  • Anastomotic Failure of Flap
  • Anastomotic Leak Large Intestine
  • Anastomotic Complication
  • Anastomotic Dehiscence in Colorectal Surgery
  • Anastomotic Leakage in Colon Surgery
  • Oxygen Delivery
  • Oxygen Delivery (DO2)

Sponsors & Collaborators

  • Saint Camillus International University of Health Sciences

    lead OTHER

Principal Investigators

  • Diego Fiume, MD PhD · UniCamillus - Saint Camillus International University of Health and Medical Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-08-31
Completion
2022-09-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099820 on ClinicalTrials.gov