Polyp of Large IntestinePhase 3PANEX3NCT02343601
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery
A Phase 3 study testing Photoplethysmography in people with Polyp of Large Intestine and Colorectal Neoplasms, run by University Hospital, Caen at 1 site in France.
Trial summary
The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Polyp of Large Intestine, Colorectal Neoplasms, Crohn Disease
- What is being tested?
- Photoplethysmography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2016
- Phase
- Phase 3
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years
- Colorectal surgery
Who cannot join
- Pregnant women
- Black skin
- Chronic renal insufficiency (MDRD <30 ml/min)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study
The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.
Read the detailed description
All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.
- Being tested
- Photoplethysmography
- Medical subject headings
- Colorectal Neoplasms, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotoplethysmographyDevice
Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group using a hemodynamic standard protocol |
| Photoplethysmography group | Other | Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA) Receives: Device: Photoplethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients presenting at least one complication after colorectal surgery
Two independent experts defined the presence of complication using an a priori classification.
Measured: Up to 28 days after surgery (length of hospital stay)
Secondary outcomes (3)
All complications happening after colorectal surgery
Measured: Up to 28 days after surgery (length of hospital stay)
Real length of hospital stay
Measured: Up to 28 days after surgery (length of hospital stay)
Perioperative mortality
Measured: 28 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 posted22 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyp of Large IntestineStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Lise Fiant, MD, Principal investigator, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343601
- Sponsor's protocol ID
- 2014-A00870-47
- Acronym
- PANEX3
- Status last verified
- May 2019
- First submitted
- 13 Jun 2014
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischer MO, Fiant AL, Boutros M, Flais F, Filipov T, Debroczi S, Pasqualini L, Rhanem T, Gerard JL, Guittet L, Hanouz JL, Alves A, Parienti JJ; PANEX3 study group. Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 22;17:159. doi: 10.1186/s13063-016-1278-4.
PubMed 27004412
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02343601
- Acronym / sponsor ID
- PANEX3 / 2014-A00870-47
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jan 2015 (estimated)
- 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.
The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.
Detailed description
All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group using a hemodynamic standard protocol |
| Photoplethysmography group | Other | Device: PhotoplethysmographyHemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age> 18 years
- Colorectal surgery
Key exclusion criteria (3 listed)
- Pregnant women
- Black skin
- Chronic renal insufficiency (MDRD <30 ml/min)
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 |
|---|---|---|
| PhotoplethysmographyUse Photoplethysmography for hemodynamic optimization during colorectal perioperative period | Device | Photoplethysmography group |
Primary outcome
Incidence of patients presenting at least one complication after colorectal surgery
Time frame: Up to 28 days after surgery (length of hospital stay)
Two independent experts defined the presence of complication using an a priori classification.
3 secondary outcomes
All complications happening after colorectal surgery
Time frame: Up to 28 days after surgery (length of hospital stay)
Real length of hospital stay
Time frame: Up to 28 days after surgery (length of hospital stay)
Perioperative mortality
Time frame: 28 days after surgery
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 2 Apr 2026.
- Results publication: PubMed 27004412Fischer MO, Fiant AL, Boutros M, Flais F, Filipov T, Debroczi S, Pasqualini L, Rhanem T, Gerard JL, Guittet L, Hanouz JL, Alves A, Parienti JJ; PANEX3 study group. Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 22;17:159. doi: 10.1186/s13063-016-1278-4.
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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. This study is not recruiting at the moment.
Anne-Lise Fiant, MD principal investigator
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Photoplethysmography in people with Polyp of Large Intestine and Colorectal Neoplasms, run by University Hospital, Caen at 1 site in France.
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 3 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 2 Apr 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of patients presenting at least one complication after colorectal surgery (time frame: Up to 28 days after surgery (length of hospital stay)). 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 NCT02343601, which also lists 1 linked publication.
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 2 Apr 2026.