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

NOT_RECRUITINGSponsored by Saint Camillus International University of Health Sciences
No longer 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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