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

NCT07099820 | Completed

• 1 other identifier: 00154/20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

anastomosis; anastomotic leaks; anastomosis leaking; colorectal surgery; colon surgery; oxygen delivery; DO2; DO2I; non-invasive monitoring

Outcome Measures

Primary Outcomes (1)

• Post-operative anastomotic dehiscence

  Breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments

  perioperatively

Secondary Outcomes (3)

• Length of Stay

  perioperatively

• Transfusions

  perioperatively

• Mortality

  perioperatively

Study Arms (1)

Patients suffering from neoplasm of the colo-rectum

Patients underwent colic resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Department of Generale Surgery, St.Eugenio Hospital, Rome, Italy

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Saint Camillus International University of Health Sciences: lead

Study Sites (1)

St. Eugenio Hospital

Rome, 00144, Italy

Location

Related Publications (27)

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MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diego Fiume, MD PhD

  UniCamillus - Saint Camillus International University of Health and Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: September 15, 2022
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)