Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomosis; Complications | — | UNRESOLVED | — |
| Anastomosis, Leaking | — | UNRESOLVED | — |
| Anastomosis, Surgical | — | UNRESOLVED | — |
| Anastomotic Complication | — | UNRESOLVED | — |
| Anastomotic Dehiscence in Colorectal Surgery | — | UNRESOLVED | — |
| Anastomotic Failure of Flap | — | UNRESOLVED | — |
| Anastomotic Leakage in Colon Surgery | — | UNRESOLVED | — |
| Anastomotic Leak Large Intestine | — | UNRESOLVED | — |
| Anastomotic Leaks | — | UNRESOLVED |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients suffering from neoplasm of the colo-rectum
- description
- Patients underwent colic resection
Primary outcomes (1)
- measure
- Post-operative anastomotic dehiscence
- timeFrame
- perioperatively
- description
- Breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments
Secondary outcomes (3)
- measure
- Length of Stay
- timeFrame
- perioperatively
- description
- Days in hospital
- measure
- Transfusions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (27)
- BACKGROUNDSciuto A, Merola G, De Palma GD, Sodo M, Pirozzi F, Bracale UM, Bracale U. Predictive factors for anastomotic leakage after laparoscopic colorectal surgery. World J Gastroenterol. 2018 Jun 7;24(21):2247-2260. doi: 10.3748/wjg.v24.i21.2247. PMID 29881234
- BACKGROUNDKrarup PM, Nordholm-Carstensen A, Jorgensen LN, Harling H. Anastomotic leak increases distant recurrence and long-term mortality after curative resection for colonic cancer: a nationwide cohort study. Ann Surg. 2014 May;259(5):930-8. doi: 10.1097/SLA.0b013e3182a6f2fc. PMID 24045445
- BACKGROUNDAlvandipour M, Mokhtari-Esbuie F, Baradari AG, Firouzian A, Rezaie M. Effect of Hyperoxygenation During Surgery on Surgical Site Infection in Colorectal Surgery. Ann Coloproctol. 2019 Feb;35(1):9-14. doi: 10.3393/ac.2018.01.16. Epub 2019 Feb 28. PMID 30879279
- BACKGROUNDShoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988 Dec;94(6):1176-86. doi: 10.1378/chest.94.6.1176. PMID 3191758
- BACKGROUNDLevy BF, Fawcett WJ, Scott MJ, Rockall TA. Intra-operative oxygen delivery in infusion volume-optimized patients undergoing laparoscopic colorectal surgery within an enhanced recovery programme: the effect of different analgesic modalities. Colorectal Dis. 2012 Jul;14(7):887-92. doi: 10.1111/j.1463-1318.2011.02805.x. PMID 21895923
- BACKGROUNDSangkum L, Liu GL, Yu L, Yan H, Kaye AD, Liu H. Minimally invasive or noninvasive cardiac output measurement: an update. J Anesth. 2016 Jun;30(3):461-80. doi: 10.1007/s00540-016-2154-9. Epub 2016 Mar 9. PMID 26961819
- BACKGROUNDAmeloot K, Palmers PJ, Malbrain ML. The accuracy of noninvasive cardiac output and pressure measurements with finger cuff: a concise review. Curr Opin Crit Care. 2015 Jun;21(3):232-9. doi: 10.1097/MCC.0000000000000198.