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

Inclusion Criteria2

  • • Age \> 18 years
  • Candidates for elective laparoscopic colo-rectal surgery for neoplastic pathology with ileo-colic, colo-colic and colo-rectal anastomosis.

Exclusion Criteria7

  • • 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).

Locations(1)

St. Eugenio Hospital

Rome, Italy

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NCT07099820


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