Anastomosis; ComplicationsNCT07099820
Role of Indexed Oxygen Delivery in Anastomotic Insufficiencies in Elective Laparoscopic Colorectal Resections for Cancer
An observational study of Anastomosis; Complications and Anastomosis, Surgical, run by Saint Camillus International University of Health Sciences at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomosis; Complications, Anastomosis, Surgical, Anastomosis, Leaking
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 15 Sep 2022
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of Generale Surgery, St.Eugenio Hospital, Rome, Italy
Who may be able to join
- • Age > 18 years
- Candidates for elective laparoscopic colo-rectal surgery for neoplastic pathology with ileo-colic, colo-colic and colo-rectal anastomosis.
Who cannot join
- • 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Indexed Oxygen Delivery in Anastomotic Insufficiencies in Elective Laparoscopic Colorectal Resections for Cancer: a Prospective Observational Cohort Study
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%.
Read more
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.
Read the detailed description
Colorectal cancer is the third most commonly diagnosed malignancy worldwide, accounting for ~10% of all cancers and ranking as the fourth leading cause of cancer death, with 1.9 million new cases and ~930,000 deaths in 2020. Surgical resection remains the mainstay of treatment for nonmetastatic cases and plays a crucial role in managing metastatic disease. Outcomes depend on preoperative staging, surgical quality, complication rates, and multidisciplinary care. Since Jacobs' 1991 report of 20 laparoscopic resections, minimally invasive techniques have reduced local and systemic complications. However, anastomotic dehiscence (AD) remains the most significant local complication, increasing hospital stays, costs, morbidity, mortality, and negatively affecting overall prognosis.
The International Study Group of Rectal Cancer defines AD as a breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments. Mortality rates vary widely, from 1.7% in an Australian cohort to as high as 29% in other reports, with AD accounting for roughly one-third of postoperative colorectal surgery deaths. Incidence is site-dependent: 1-20% in colo-rectal, 0-2% in colo-colic, and 0.02-4% in ileo-colic anastomoses.
Risk factors are categorized as local or systemic. Local factors include anastomotic level, technique (mechanical vs. manual), surgeon experience, bowel prep, use of laparoscopy, diverting stomas, drains, radiotherapy, chemotherapy, and gut microbiota. Systemic factors include male sex, malnutrition, hypoalbuminemia, anemia, comorbidities, American Society of Anesthesiologists (ASA) score, nonsteroidal anti-inflammatory drug (NSAID) use, smoking, alcohol, peripheral vascular disease, obesity, and diabetes. 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. A DO2I < 400 ml/min/m² is associated with increased AD risk; normal values range from 450-550 ml/min/m². Below this, compensation through increased extraction fails beyond a critical threshold, leading to anaerobic metabolism and lactic acidosis. Accurate DO2I calculation requires cardiac output monitoring.
While the esophageal Doppler is the standard for cardiac output measurement, its invasiveness and operator dependence limit use. Less invasive alternatives, like pulse-contouring (e.g., PiCCO, Vigileo) or fully non-invasive methods like ClearSight®, offer continuous hemodynamic data. ClearSight® uses the volume-clamp method via a finger cuff and photoplethysmography to measure real-time arterial pressure and advanced parameters such as cardiac output and stroke volume.
DO2I calculation also requires hemoglobin levels, which fluctuate intraoperatively due to blood loss and fluid shifts. Reliable measurement would ideally involve repeated blood sampling, which adds invasiveness and cost. Advances in pulse oximetry, like the Rad-97 Pulse CO-Oximeter® (Masimo), allow continuous non-invasive monitoring of O₂ saturation, Hb, carboxyhemoglobin, methemoglobin, perfusion index, and more, even under low perfusion or motion conditions.
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
- Keywords
- anastomosis, anastomotic leaks, anastomosis leaking, colorectal surgery, colon surgery, oxygen delivery, DO2, DO2I, non-invasive monitoring
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from neoplasm of the colo-rectum | Patients underwent colic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative anastomotic dehiscence
Breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments
Measured: perioperatively
Secondary outcomes (3)
Length of Stay
Days in hospital
Measured: perioperatively
Transfusions
Number of blood units transfused
Measured: perioperatively
Mortality
Death
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2020
- Primary completion31 Aug 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Anastomosis; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Saint Camillus International University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Fiume, Saint Camillus International University of Health Sciences
- Investigators
- Diego Fiume, MD PhD, Study chair, UniCamillus - Saint Camillus International University of Health and Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099820
- Sponsor's protocol ID
- 00154/20
- Status last verified
- Mar 2026
- First submitted
- 22 Jul 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share Individual Participant Data (IPD); however, anonymized data may be made available upon reasonable request, subject to sponsor approval and ethical considerations.
Publications
Sciuto 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.
PubMed 29881234Krarup 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.
PubMed 24045445Alvandipour 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.
PubMed 30879279Shoemaker 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.
PubMed 3191758Levy 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.
PubMed 21895923Sangkum 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.
PubMed 26961819Ameloot 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.
PubMed 25922896Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Piccione F, Amicucci G. Prevention of anastomotic leakage after total gastrectomy with perioperative supplemental oxygen administration: a prospective randomized, double-blind, controlled, single-center trial. Ann Surg Oncol. 2013 May;20(5):1584-90. doi: 10.1245/s10434-012-2714-7. Epub 2012 Oct 26.
PubMed 23099730Meyer J, Naiken S, Christou N, Liot E, Toso C, Buchs NC, Ris F. Reducing anastomotic leak in colorectal surgery: The old dogmas and the new challenges. World J Gastroenterol. 2019 Sep 14;25(34):5017-5025. doi: 10.3748/wjg.v25.i34.5017.
PubMed 31558854Carlini M, Grieco M, Spoletini D, Menditto R, Napoleone V, Brachini G, Mingoli A, Marcellinaro R. Implementation of the gut microbiota prevents anastomotic leaks in laparoscopic colorectal surgery for cancer:the results of the MIRACLe study. Updates Surg. 2022 Aug;74(4):1253-1262. doi: 10.1007/s13304-022-01305-6. Epub 2022 Jun 23.
PubMed 35739383Vasiliu EC, Zarnescu NO, Costea R, Neagu S. Review of Risk Factors for Anastomotic Leakage in Colorectal Surgery. Chirurgia (Bucur). 2015 Jul-Aug;110(4):319-26.
PubMed 26305194Crafa F, Smolarek S, Missori G, Shalaby M, Quaresima S, Noviello A, Cassini D, Ascenzi P, Franceschilli L, Delrio P, Baldazzi G, Giampiero U, Megevand J, Maria Romano G, Sileri P. Transanal Inspection and Management of Low Colorectal Anastomosis Performed With a New Technique: the TICRANT Study. Surg Innov. 2017 Oct;24(5):483-491. doi: 10.1177/1553350617709182. Epub 2017 May 17.
PubMed 28514887Ito M, Sugito M, Kobayashi A, Nishizawa Y, Tsunoda Y, Saito N. Relationship between multiple numbers of stapler firings during rectal division and anastomotic leakage after laparoscopic rectal resection. Int J Colorectal Dis. 2008 Jul;23(7):703-7. doi: 10.1007/s00384-008-0470-8. Epub 2008 Apr 1.
PubMed 18379795Hyman N, Manchester TL, Osler T, Burns B, Cataldo PA. Anastomotic leaks after intestinal anastomosis: it's later than you think. Ann Surg. 2007 Feb;245(2):254-8. doi: 10.1097/01.sla.0000225083.27182.85.
PubMed 17245179Phitayakorn R, Delaney CP, Reynolds HL, Champagne BJ, Heriot AG, Neary P, Senagore AJ; International Anastomotic Leak Study Group. Standardized algorithms for management of anastomotic leaks and related abdominal and pelvic abscesses after colorectal surgery. World J Surg. 2008 Jun;32(6):1147-56. doi: 10.1007/s00268-008-9468-1.
PubMed 18283511
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Indexed Oxygen Delivery in Anastomotic Insufficiencies in Elective Laparoscopic Colorectal Resections for Cancer: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07099820
- Acronym / sponsor ID
- 00154/20
- Conditions
- Anastomosis; Complications, Anastomosis, Surgical, Anastomosis, Leaking, Anastomotic Leaks, Anastomotic Failure of Flap, Anastomotic Leak Large Intestine
- Keywords
- anastomosis, anastomotic leaks, anastomosis leaking, colorectal surgery, colon surgery, oxygen delivery, DO2, DO2I
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saint Camillus International University of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Colorectal cancer is the third most commonly diagnosed malignancy worldwide, accounting for ~10% of all cancers and ranking as the fourth leading cause of cancer death, with 1.9 million new cases and ~930,000 deaths in 2020. Surgical resection remains the mainstay of treatment for nonmetastatic cases and plays a crucial role in managing metastatic disease. Outcomes depend on preoperative staging, surgical quality, complication rates, and multidisciplinary care. Since Jacobs' 1991 report of 20 laparoscopic resections, minimally invasive techniques have reduced local and systemic complications. However, anastomotic dehiscence (AD) remains the most significant local complication, increasing hospital stays, costs, morbidity, mortality, and negatively affecting overall prognosis.
The International Study Group of Rectal Cancer defines AD as a breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments. Mortality rates vary widely, from 1.7% in an Australian cohort to as high as 29% in other reports, with AD accounting for roughly one-third of postoperative colorectal surgery deaths. Incidence is site-dependent: 1-20% in colo-rectal, 0-2% in colo-colic, and 0.02-4% in ileo-colic anastomoses.
Risk factors are categorized as local or systemic. Local factors include anastomotic level, technique (mechanical vs. manual), surgeon experience, bowel prep, use of laparoscopy, diverting stomas, drains, radiotherapy, chemotherapy, and gut microbiota. Systemic factors include male sex, malnutrition, hypoalbuminemia, anemia, comorbidities, American Society of Anesthesiologists (ASA) score, nonsteroidal anti-inflammatory drug (NSAID) use, smoking, alcohol, peripheral vascular disease, obesity, and diabetes. 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. A DO2I < 400 ml/min/m² is associated with increased AD risk; normal values range from 450-550 ml/min/m². Below this, compensation through increased extraction fails beyond a critical threshold, leading to anaerobic metabolism and lactic acidosis. Accurate DO2I calculation requires cardiac output monitoring.
While the esophageal Doppler is the standard for cardiac output measurement, its invasiveness and operator dependence limit use. Less invasive alternatives, like pulse-contouring (e.g., PiCCO, Vigileo) or fully non-invasive methods like ClearSight®, offer continuous hemodynamic data. ClearSight® uses the volume-clamp method via a finger cuff and photoplethysmography to measure real-time arterial pressure and advanced parameters such as cardiac output and stroke volume.
DO2I calculation also requires hemoglobin levels, which fluctuate intraoperatively due to blood loss and fluid shifts. Reliable measurement would ideally involve repeated blood sampling, which adds invasiveness and cost. Advances in pulse oximetry, like the Rad-97 Pulse CO-Oximeter® (Masimo), allow continuous non-invasive monitoring of O₂ saturation, Hb, carboxyhemoglobin, methemoglobin, perfusion index, and more, even under low perfusion or motion conditions.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from neoplasm of the colo-rectum | – | –Patients underwent colic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Generale Surgery, St.Eugenio Hospital, Rome, Italy
Key inclusion criteria (2 listed)
- • Age > 18 years
Key exclusion criteria (7 listed)
- • Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative anastomotic dehiscence
Time frame: perioperatively
Breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments
3 secondary outcomes
Length of Stay
Time frame: perioperatively
Transfusions
Time frame: perioperatively
Mortality
Time frame: perioperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 29881234Sciuto 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.
- Background: PubMed 24045445Krarup 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.
- Background: PubMed 30879279Alvandipour 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.
- Background: PubMed 3191758Shoemaker 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.
- Background: PubMed 21895923Levy 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.
- Background: PubMed 26961819Sangkum 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.
- Background: PubMed 25922896Ameloot 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.
- Background: PubMed 23099730Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Piccione F, Amicucci G. Prevention of anastomotic leakage after total gastrectomy with perioperative supplemental oxygen administration: a prospective randomized, double-blind, controlled, single-center trial. Ann Surg Oncol. 2013 May;20(5):1584-90. doi: 10.1245/s10434-012-2714-7. Epub 2012 Oct 26.
- Background: PubMed 31558854Meyer J, Naiken S, Christou N, Liot E, Toso C, Buchs NC, Ris F. Reducing anastomotic leak in colorectal surgery: The old dogmas and the new challenges. World J Gastroenterol. 2019 Sep 14;25(34):5017-5025. doi: 10.3748/wjg.v25.i34.5017.
- Background: PubMed 35739383Carlini M, Grieco M, Spoletini D, Menditto R, Napoleone V, Brachini G, Mingoli A, Marcellinaro R. Implementation of the gut microbiota prevents anastomotic leaks in laparoscopic colorectal surgery for cancer:the results of the MIRACLe study. Updates Surg. 2022 Aug;74(4):1253-1262. doi: 10.1007/s13304-022-01305-6. Epub 2022 Jun 23.
- Background: PubMed 26305194Vasiliu EC, Zarnescu NO, Costea R, Neagu S. Review of Risk Factors for Anastomotic Leakage in Colorectal Surgery. Chirurgia (Bucur). 2015 Jul-Aug;110(4):319-26.
- Background: PubMed 28514887Crafa F, Smolarek S, Missori G, Shalaby M, Quaresima S, Noviello A, Cassini D, Ascenzi P, Franceschilli L, Delrio P, Baldazzi G, Giampiero U, Megevand J, Maria Romano G, Sileri P. Transanal Inspection and Management of Low Colorectal Anastomosis Performed With a New Technique: the TICRANT Study. Surg Innov. 2017 Oct;24(5):483-491. doi: 10.1177/1553350617709182. Epub 2017 May 17.
- Individual participant dataSharing planned: No. There is no plan to share Individual Participant Data (IPD); however, anonymized data may be made available upon reasonable request, subject to sponsor approval and ethical considerations.
Related trials for Anastomosis; Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Active, not recruiting
Feasibility Study of Middle Segmental Gastrectomy (MSG) for Gastric Cancer.
Gastric Cancer, Gastric Adenocarcinoma
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Fiume, MD PhD study chair
UniCamillus - Saint Camillus International University of Health and Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomosis; Complications and Anastomosis, Surgical, run by Saint Camillus International University of Health Sciences at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative anastomotic dehiscence (time frame: perioperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07099820, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.