Rectal CancerLIRANCT07799740
Examination of Rectal Blood Supply During Rectal Cancer Surgery Using Laser Speckle Contrast Imaging
A study testing Laser speckle contrast imaging in people with Rectal Cancer and Total Mesorectal Excision, run by University of Aarhus at 2 sites in Denmark.
Trial summary
This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Total Mesorectal Excision, Laser Speckle Contrast Imaging
- What is being tested?
- Laser speckle contrast imaging
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Sep 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years
- Rectal cancer
- Surgical strategy either partial or total mesorectal excision
- Able to provide informed consent
Who cannot join
- Allergy to iodine
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Regional Hospital Gødstrup
Herning
Nickolai M Kristensen, MD, +45 30335786, nickks@rm.dk
Sygehus Lillebælt, Vejle Hospital
Vejle
Pernille Ø Larsen, MD, consultant, +45 79 40 56 04, pernille.oehlenschlager.larsen0@rsyd.dk
About this study
Official title: Laser Speckle Contrast Imaging for Rectal Anastomotic Evaluation (LIRA): A Feasibility Study.
This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. To our knowledge, LSCI has not previously been applied laparoscopically for intraoperative assessment of rectal perfusion in this setting. Laparoscopic LSCI measurements will be compared with indocyanine green fluorescence imaging, and associations between quantitative measures of colorectal perfusion and postoperative outcomes, including anastomotic leakage, will be explored.
- Conditions
- Rectal Cancer, Total Mesorectal Excision, Laser Speckle Contrast Imaging, Indocyanine Green (ICG), Optical Imaging
- Being tested
- Laser speckle contrast imaging
- Keywords
- Laser speckle contrast imaging, Rectal cancer, Total Mesorectal Excision, Indocyanine Green Fluorescent Imaging
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser speckle contrast imagingDevice
Investigated device: PerfusiX-Imaging, LIMIS Development B.V., The Netherlands ICG-FI: Verdye, 0.2 mg/kg, Firefly® fluorescence imaging
PerfusiX-Imaging is used Intracorporally prior to anal specimen transection, extracoporally prior to oral speciamen transection, intracorporally assessing the free bowel ends prior to anastomotic formation. ICG-FI is applied intracorporally assessing the free bowel ends prior to anastomotic formation.
Diagnostic imaging: All participants undergo computed tomography with intravenous contrast and a rectal contrast enema.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative aided assessment of intestinal microcirculation | Experimental | Participants undergoing total mesorectal excision (TME) for rectal cancer will undergo intraoperative assessment of rectal perfusion using laser speckle contrast imaging (LSCI) and indocyanine green fluorescence imaging (ICG-FI). Four to six days after TME, all participants will undergo computed tomography (CT) with intravenous contrast and a rectal contrast enema to assess for anastomotic leakage.
Participants must be older than 18 years of age and provide informed consent prior to inclusion. Receives: Device: Laser speckle contrast imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging
Feasibility is considered demonstrated if time spent on PerfusiX-Imaging measurements is ≤ 5% of total operating time and no more than two measurements are required to obtain a sufficient assessment of intestinal microcirculation.
Unit:
Percentage of participants with succesful assessment
Measured: Intraoperatively
Surgeon-reported acceptability of PerfusiX-Imaging
Surgeons will assess the acceptability and performance of PerfusiX-Imaging using a predefined Likert-scale questionnaire. Feasibility will be considered demonstrated if >80% of surgeons report a positive evaluation of PerfusiX-Imaging. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions.
Unit:
Percentage of surgeons with a positive evaluation
Measured: intraoperatively
Potential impact of PerfusiX-Imaging on surgical decision making
The distance between the marked oral transection line with and without the use of PerfusiX-Imaging given by the surgeon and an independent expert. Feasibility will be considered demonstrated if the transection line differs by ≥ 10 mm.
Unit: milimetres (mm)
Measured: Intraoperatively
Secondary outcomes (8)
Comparison of surgeon-reported acceptability between PerfusiX-Imaging and ICG-FI
Surgeons will assess the acceptability and performance of PerfusiX-Imaging and ICG-FI using a predefined Likert-scale questionnaire. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. The proportion of surgeons providing a positive evaluation of PerfusiX-Imaging will be compared with the proportion providing a positive evaluation on ICG-FI.
Unit of measure:
Proportion of surgeons
Measured: Immediately after surgery
Absolute intestinal microcirculation
Intestinal microcirculation will be quantified using laser speckle contrast imaging (LSCI). Absolute microcirculation will be expressed as the mean laser speckle perfusion unit (LSPU) value obtained from a predefined region of interest (ROI) close to the intestinal anastomotic line.
Unit of measure:
Laser speckle perfusion units, LSPU
Measured: Intraoperatively
Relative intestinal microcirculation
Relative intestinal microcirculation will be calculated by normalizing the mean LSPU value from a region of interest to the mean LSPU value obtained from a reference region on the intestines:
Unit of measure:
Percentage (%): measurement/control*100
Measured: Intraoperatively
Length of initial hospital stay after surgery
Length of initial hospital stay after surgery will be calculated as the number of hours from the end of surgery until initial discharge from hospital. The association between length of initial hospital stay after surgery and quantitative measurements of intestinal microcirculation will be explored.
Unit of measure:
Hours
Measured: From the end of surgery until initial hospital discharge, up to 30 days after surgery
Severity of postoperative complications according to the Clavien-Dindo classification
Postoperative complications occuring within 30 days after surgery will be graded according to the Clavien-Dindo classification (Grade I-V). The asociation between quatitative measurements of intestinal microcirculation and the severity of postoperative complications will be explored.
Units of measure:
Clavien-Dindo
Measured: 30 days after surgery
Surgical complications within 30 days after surgery
The occurence of surgical complications within 30 days after surgery will be recorded. Surgical complications include bleeding, fascial dehiscence, postoperative ileus, surgical site infection, intraabdominal abscess, stoma related complications. The association between surgical complications within 30 days after surgery and quantitative measurements of intestinal microcirculation will be explored.
Units of measure:
Participants with one or more surgical complications
Measured: 30 days after surgery
Medical complications within 30 days after surgery
The occurence of medical complications within 30 days after surgery will be recorded. Medical complicatinos include stroke, myocardial infarction, heart failure, pneumonia, aspiration, respiratory failure, deep vein thrombosis, acute arterial insufficiency and sepsis. The association between medical complications within 30 days after surgery and quantitative measurements of intestinal microcirculation will be explored
Units of measure:
Participants with one or more medical complications
Measured: 30 days after surgery
Anastomotic leakage within 30 days of surgery
Occurrence of anastomotic leakage within 30 days after surgery will be recorded as a binary outcome (yes/no). The association between anastomotic leakage and quantitative measurements of intestinal microcirculation will be explored.
Units of measure:
Participants with anastomotic leakage
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The primary objective of this clinical investigation is to assess the feasibility of performing laparoscopic laser speckle contrast imaging (LSCI) measurements of intestinal perfusion during rectal cancer surgery. Feasibility will be evaluated in terms of technical feasibility, usability and acceptability among surgeons, and potential influence on surgical decision-making. Secondary objectives include comparison of LSCI with indocyanine green fluorescence imaging, assessment of quantitative perfusion measurements, and exploration of associations between perfusion measurements and postoperative outcomes.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Gødstrup Hospital, Vejle Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799740
- Sponsor's protocol ID
- 1068706
- Acronym
- LIRA
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Identifiable personal data will not be disclosed to third parties.
Publications
Danish Colorectal Cancer Group, DCCG Årsrapport 1. januar 2023 - 31. december 2023.
Power SP, Moloney F, Twomey M, James K, O'Connor OJ, Maher MM. Computed tomography and patient risk: Facts, perceptions and uncertainties. World J Radiol. 2016 Dec 28;8(12):902-915. doi: 10.4329/wjr.v8.i12.902.
PubMed 28070242Axt S, Haller K, Wilhelm P, Falch C, Martus P, Johannink J, Rolinger J, Beltzer C, Axt L, Konigsrainer A, Kirschniak A. Early postoperative endoscopic evaluation of rectal anastomoses: a prospective cross-sectional study. Surg Endosc. 2022 Dec;36(12):8881-8892. doi: 10.1007/s00464-022-09323-6. Epub 2022 May 23.
PubMed 35606545Valentin J; International Commission on Radiation Protection. Managing patient dose in multi-detector computed tomography(MDCT). ICRP Publication 102. Ann ICRP. 2007;37(1):1-79, iii. doi: 10.1016/j.icrp.2007.09.001.
PubMed 18069128Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
PubMed 19362699Heuvelings DJI, Al-Taher M, Calon J, Chand M, Stassen LPS, Lubbers T, Wevers KP, Boni L, Bouvy ND, Heeman W. Real-time intestinal perfusion assessment for anastomotic site selection using laser speckle contrast imaging: Verification in a porcine model. Surg Open Sci. 2025 Apr 18;26:12-17. doi: 10.1016/j.sopen.2025.04.007. eCollection 2025 Jun.
PubMed 40933467Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019 Feb;269(2):211-220. doi: 10.1097/SLA.0000000000002794.
PubMed 29697448Heeman W, Steenbergen W, van Dam G, Boerma EC. Clinical applications of laser speckle contrast imaging: a review. J Biomed Opt. 2019 Aug;24(8):1-11. doi: 10.1117/1.JBO.24.8.080901.
PubMed 31385481Coraci MM, Schouw HM, Kruijff S, Mao Y, Noltes ME, Heeman W. Comparison of quantitative laser speckle contrast and indocyanine green imaging for intestinal perfusion measurements in robot assisted surgery. Sci Rep. 2025 Jul 1;15(1):21664. doi: 10.1038/s41598-025-05496-x.
PubMed 40596151Heeman W, Calon J, van der Bilt A, Pierie JEN, Pereboom I, van Dam GM, Boerma EC. Dye-free visualisation of intestinal perfusion using laser speckle contrast imaging in laparoscopic surgery: a prospective, observational multi-centre study. Surg Endosc. 2023 Dec;37(12):9139-9146. doi: 10.1007/s00464-023-10493-0. Epub 2023 Oct 9.
PubMed 37814165Paramasivam R, Jaensch C, Madsen AH, Orntoft MW. Intraoperative assessment of anastomotic microcirculation during right hemicolectomy with real-time laser speckle contrast imaging is safe and feasible. Colorectal Dis. 2025 Jul;27(7):e70162. doi: 10.1111/codi.70162.
PubMed 40671310Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.
PubMed 39151436Mc Entee PD, Singaravelu A, Boland PA, Moynihan A, Creavin B, Cahill RA. Impact of indocyanine green fluorescence angiography on surgeon action and anastomotic leak in colorectal resections. A systematic review and meta-analysis. Surg Endosc. 2025 Mar;39(3):1473-1489. doi: 10.1007/s00464-025-11582-y. Epub 2025 Feb 3.
PubMed 39900861Fang C, Nie P, Jing P, Zhang Y, Yang L, Yu Y, Wang C, Zhou Z. Effects of Adjuvant Therapy Compliance and Anastomotic Leakage on the Oncologic Outcomes of Patients With Rectal Cancer After Curative Resection. Dis Colon Rectum. 2021 Jun 1;64(6):689-696. doi: 10.1097/DCR.0000000000001824.
PubMed 33394777Gielen AHC, Heuvelings DJI, Sylla P, van Loon YT, Melenhorst J, Bouvy ND, Kimman ML, Breukink SO; CoReAL Collaborative. Impact of Anastomotic Leakage After Colorectal Cancer Surgery on Quality of Life: A Systematic Review. Dis Colon Rectum. 2025 Feb 1;68(2):154-170. doi: 10.1097/DCR.0000000000003478. Epub 2024 Oct 23.
PubMed 39440840
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Speckle Contrast Imaging for Rectal Anastomotic Evaluation (LIRA): A Feasibility Study.
- ClinicalTrials.gov ID
- NCT07799740
- Acronym / sponsor ID
- LIRA / 1068706
- Conditions
- Rectal Cancer, Total Mesorectal Excision, Laser Speckle Contrast Imaging, Indocyanine Green (ICG), Optical Imaging
- Keywords
- Laser speckle contrast imaging, Rectal cancer, Total Mesorectal Excision, Indocyanine Green Fluorescent Imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Gødstrup Hospital, Vejle Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 2 Sep 2026 (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.
This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. To our knowledge, LSCI has not previously been applied laparoscopically for intraoperative assessment of rectal perfusion in this setting. Laparoscopic LSCI measurements will be compared with indocyanine green fluorescence imaging, and associations between quantitative measures of colorectal perfusion and postoperative outcomes, including anastomotic leakage, will be explored.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The primary objective of this clinical investigation is to assess the feasibility of performing laparoscopic laser speckle contrast imaging (LSCI) measurements of intestinal perfusion during rectal cancer surgery. Feasibility will be evaluated in terms of technical feasibility, usability and acceptability among surgeons, and potential influence on surgical decision-making. Secondary objectives include comparison of LSCI with indocyanine green fluorescence imaging, assessment of quantitative perfusion measurements, and exploration of associations between perfusion measurements and postoperative outcomes.
| Arm | Type | Receives |
|---|---|---|
| Intraoperative aided assessment of intestinal microcirculation | Experimental | Device: Laser speckle contrast imagingParticipants undergoing total mesorectal excision (TME) for rectal cancer will undergo intraoperative assessment of rectal perfusion using laser speckle contrast imaging (LSCI) and indocyanine green fluorescence imaging (ICG-FI). Four to six days after TME, all participants will undergo computed tomography (CT) with intravenous contrast and a rectal contrast enema to assess for anastomotic leakage. Participants must be older than 18 years of age and provide informed consent prior to inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Rectal cancer
- Surgical strategy either partial or total mesorectal excision
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Allergy to iodine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser speckle contrast imagingInvestigated device: PerfusiX-Imaging, LIMIS Development B.V., The Netherlands ICG-FI: Verdye, 0.2 mg/kg, Firefly® fluorescence imaging PerfusiX-Imaging is used Intracorporally prior to anal specimen transection, extracoporally prior to oral speciamen transection, intracorporally assessing the free bowel ends prior to anastomotic formation. ICG-FI is applied intracorporally assessing the free bowel ends prior to anastomotic formation. Diagnostic imaging: All participants undergo computed tomography with intravenous contrast and a rectal contrast enema. | Device | Intraoperative aided assessment of intestinal microcirculation |
Primary outcome
Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging
Time frame: Intraoperatively
Feasibility is considered demonstrated if time spent on PerfusiX-Imaging measurements is ≤ 5% of total operating time and no more than two measurements are required to obtain a sufficient assessment of intestinal microcirculation. Unit: Percentage of participants with succesful assessment
Surgeon-reported acceptability of PerfusiX-Imaging
Time frame: intraoperatively
Surgeons will assess the acceptability and performance of PerfusiX-Imaging using a predefined Likert-scale questionnaire. Feasibility will be considered demonstrated if >80% of surgeons report a positive evaluation of PerfusiX-Imaging. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. Unit: Percentage of surgeons with a positive evaluation
Potential impact of PerfusiX-Imaging on surgical decision making
Time frame: Intraoperatively
The distance between the marked oral transection line with and without the use of PerfusiX-Imaging given by the surgeon and an independent expert. Feasibility will be considered demonstrated if the transection line differs by ≥ 10 mm. Unit: milimetres (mm)
8 secondary outcomes
Comparison of surgeon-reported acceptability between PerfusiX-Imaging and ICG-FI
Time frame: Immediately after surgery
Absolute intestinal microcirculation
Time frame: Intraoperatively
Relative intestinal microcirculation
Time frame: Intraoperatively
Length of initial hospital stay after surgery
Time frame: From the end of surgery until initial hospital discharge, up to 30 days after surgery
Severity of postoperative complications according to the Clavien-Dindo classification
Time frame: 30 days after surgery
Surgical complications within 30 days after surgery
Time frame: 30 days after surgery
Medical complications within 30 days after surgery
Time frame: 30 days after surgery
Anastomotic leakage within 30 days of surgery
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publicationDanish Colorectal Cancer Group, DCCG Årsrapport 1. januar 2023 - 31. december 2023.
- Results publication: PubMed 28070242Power SP, Moloney F, Twomey M, James K, O'Connor OJ, Maher MM. Computed tomography and patient risk: Facts, perceptions and uncertainties. World J Radiol. 2016 Dec 28;8(12):902-915. doi: 10.4329/wjr.v8.i12.902.
- Results publication: PubMed 35606545Axt S, Haller K, Wilhelm P, Falch C, Martus P, Johannink J, Rolinger J, Beltzer C, Axt L, Konigsrainer A, Kirschniak A. Early postoperative endoscopic evaluation of rectal anastomoses: a prospective cross-sectional study. Surg Endosc. 2022 Dec;36(12):8881-8892. doi: 10.1007/s00464-022-09323-6. Epub 2022 May 23.
- Results publication: PubMed 18069128Valentin J; International Commission on Radiation Protection. Managing patient dose in multi-detector computed tomography(MDCT). ICRP Publication 102. Ann ICRP. 2007;37(1):1-79, iii. doi: 10.1016/j.icrp.2007.09.001.
- Results publication: PubMed 19362699Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
- Results publication: PubMed 40933467Heuvelings DJI, Al-Taher M, Calon J, Chand M, Stassen LPS, Lubbers T, Wevers KP, Boni L, Bouvy ND, Heeman W. Real-time intestinal perfusion assessment for anastomotic site selection using laser speckle contrast imaging: Verification in a porcine model. Surg Open Sci. 2025 Apr 18;26:12-17. doi: 10.1016/j.sopen.2025.04.007. eCollection 2025 Jun.
- Results publication: PubMed 29697448Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019 Feb;269(2):211-220. doi: 10.1097/SLA.0000000000002794.
- Results publication: PubMed 31385481Heeman W, Steenbergen W, van Dam G, Boerma EC. Clinical applications of laser speckle contrast imaging: a review. J Biomed Opt. 2019 Aug;24(8):1-11. doi: 10.1117/1.JBO.24.8.080901.
- Results publication: PubMed 40596151Coraci MM, Schouw HM, Kruijff S, Mao Y, Noltes ME, Heeman W. Comparison of quantitative laser speckle contrast and indocyanine green imaging for intestinal perfusion measurements in robot assisted surgery. Sci Rep. 2025 Jul 1;15(1):21664. doi: 10.1038/s41598-025-05496-x.
- Results publication: PubMed 37814165Heeman W, Calon J, van der Bilt A, Pierie JEN, Pereboom I, van Dam GM, Boerma EC. Dye-free visualisation of intestinal perfusion using laser speckle contrast imaging in laparoscopic surgery: a prospective, observational multi-centre study. Surg Endosc. 2023 Dec;37(12):9139-9146. doi: 10.1007/s00464-023-10493-0. Epub 2023 Oct 9.
- Results publication: PubMed 40671310Paramasivam R, Jaensch C, Madsen AH, Orntoft MW. Intraoperative assessment of anastomotic microcirculation during right hemicolectomy with real-time laser speckle contrast imaging is safe and feasible. Colorectal Dis. 2025 Jul;27(7):e70162. doi: 10.1111/codi.70162.
- Results publication: PubMed 39151436Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Identifiable personal data will not be disclosed to third parties.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser speckle contrast imaging in people with Rectal Cancer and Total Mesorectal Excision, run by University of Aarhus at 2 sites in Denmark.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai-Britt W. Ørntoft, MD, Ph.D, Ass. Professor (+45 61670561, mwo@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging (time frame: Intraoperatively). The study lists 3 primary outcomes in all. 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 NCT07799740, which also lists 17 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 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.