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

RECRUITINGSponsored by Saint Camillus International University of Health Sciences
Actively Recruiting
SponsorSaint Camillus International University of Health Sciences
Started2020-09-01
Est. completion2025-08-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07099820

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* • Age \> 18 years

  * Candidates for elective laparoscopic colo-rectal surgery for neoplastic pathology with ileo-colic, colo-colic and colo-rectal anastomosis.

Exclusion Criteria:

* • Age \< 18 years

  * Inability to give valid informed consent
  * Candidates for operations involving other wards
  * Candidates for emergency surgery
  * Candidates for laparotomic surgery
  * Colo- or ileo-stomy
  * Contraindications to the use of the volume clamp system for haemodynamic monitoring (conditions with significant alteration of finger perfusion, such as Raynaud's disease).

Conditions12

Anastomosis, LeakingAnastomosis, SurgicalAnastomosis; ComplicationsAnastomotic ComplicationAnastomotic Dehiscence in Colorectal SurgeryAnastomotic Failure of FlapAnastomotic Leak Large IntestineAnastomotic Leakage in Colon SurgeryAnastomotic LeaksCancer

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