Colorectal DiseasesORCHESTRANCT07874412
Operating-Room Distractions, Surgeon Workload, Anxiety, Teamwork and Intraoperative Adverse Events (ORCHESTRA)
An observational study of Colorectal Diseases and Anal Diseases, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
During surgery, telephone calls, conversations, equipment problems and other events may distract the operating team. Some events interrupt the progress of the operation. The surgeon's workload and anxiety, together with how well the team works together, may also be related to events that occur during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Diseases, Anal Diseases
- What is being tested?
- Naturally occurring operating-room distractions and human factors
- How many people
- 400 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Observational
- 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
Study population: Consecutive eligible adult patients undergoing colorectal or anal surgery in the participating unit, performed by the designated surgeon during the study period.
Who may be able to join
- Age 18 years or older.
- Undergoing a colorectal or anal operation in the participating unit, performed by the designated surgeon, during recruitment.
- Written informed consent.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Ippokrateio Hospital
Athens
Nikolaos Ntanos, +30 213 208 8000, ntanos.nikos00@outlook.com
About this study
Official title: Association Between Intraoperative Distractions, Surgeon Anxiety and Task Load, Team Collaboration, and Intraoperative Adverse Events: The ORCHESTRA Study
During surgery, telephone calls, conversations, equipment problems and other events may distract the operating team. Some events interrupt the progress of the operation. The surgeon's workload and anxiety, together with how well the team works together, may also be related to events that occur during surgery.
ORCHESTRA is an observational study of patients undergoing colorectal or anal surgery in a single hospital. Trained observers record distractions during routine operations. After each operation, the surgeon reports workload and anxiety, and an observer assesses teamwork. Intraoperative adverse events are graded using a standard severity classification. The study examines how these measurements are related. It does not assign treatments, introduce distractions or change routine surgical care.
Read the detailed description
ORCHESTRA is a prospective, single-centre observational cohort study conducted in an academic colorectal surgery unit. Consecutive eligible patients undergoing colorectal or anal procedures performed by one designated surgeon are observed during routine surgical care. The operating surgeon and participating theatre staff gave consent to observation and questionnaire assessment at the start of the study.
Two independent observers record naturally occurring distractions in real time, including their type, operative phase and observable impact. Distractions are classified as A, potentially distracting; B, visibly distracting the team; or C, interrupting operative flow. The principal exposure is the number of C-class events per operation. Additional summaries include category-specific counts, total distraction count and a weighted score calculated as A + 2B + 3C.
Intraoperative adverse events are assessed using ClassIntra, with the maximum grade per operation serving as the primary outcome. Immediately after surgery, the operating surgeon completes the study's SURG-TLX implementation and STAI-State. Team collaboration is assessed by the observers using the study's OTAS implementation. Recorded patient and procedure characteristics include age, ASA physical status, obesity, procedure category and operative duration.
Ordinal regression examines associations with increasing ClassIntra severity. Related models consider workload and anxiety together and separately because these measures may be strongly correlated. Additional analyses describe distraction patterns, teamwork, workload and anxiety, and assess more clinically consequential events using a ClassIntra grade II or higher threshold. The study is observational and does not establish causal effects.
- Conditions
- Colorectal Diseases, Anal Diseases
- Being tested
- Naturally occurring operating-room distractions and human factors
- Keywords
- operating room, distractions, surgical flow interruptions, surgeon workload, situational anxiety, teamwork, human factors, colorectal surgery, anal surgery, ClassIntra, SURG-TLX, STAI, OTAS, intraoperative complications
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturally occurring operating-room distractions and human factorsOther
Observational recording of naturally occurring distractions and assessment of surgeon workload, situational anxiety and team collaboration during routine surgical care. No experimental exposure is assigned and no change to treatment is prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal and anal surgery cohort | Consecutive eligible patients undergoing colorectal or anal surgery performed by the designated surgeon in the participating unit. Naturally occurring distractions, surgeon workload and anxiety, team collaboration and intraoperative adverse events are assessed during the index operation. Receives: Other: Naturally occurring operating-room distractions and human factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative adverse-event severity assessed by ClassIntra
The highest ClassIntra grade recorded during the index operation. Grade 0 indicates no intraoperative adverse event; grades I through V indicate increasing severity, with grade V indicating intraoperative death. The case-level ordinal score is analysed in relation to distraction burden and other recorded patient, procedural and human-factor measurements.
Measured: During the index operation, from anaesthetic induction to extubation
Secondary outcomes (7)
ClassIntra grade II or higher intraoperative adverse event
Occurrence (yes or no) of at least one intraoperative adverse event of ClassIntra grade II or higher, representing a more clinically consequential event. Reported as the number and proportion of operations with such an event.
Measured: During the index operation, from anaesthetic induction to extubation
Surgeon state-anxiety score
STAI-State total score based on 20 items, with reverse scoring of positively worded items according to the authorised scoring key. The surgeon reports feelings during the surgical case just completed. Scores range from 20 to 80; higher scores indicate greater situational anxiety. Only complete questionnaires are scored.
Measured: Immediately after completion of the index operation
Surgeon task-load score
Study implementation of SURG-TLX using six domains rated from 1 to 5: mental demand, physical demand, temporal demand, task complexity, situational stress and distractions. The overall score is the unweighted mean of the six ratings, ranging from 1 to 5. Higher scores indicate greater workload.
Measured: Immediately after completion of the index operation
Observer-rated team collaboration score
Overall teamwork score from the study's OTAS implementation, rated by the observers on a scale from 0 to 6. A score of 0 indicates severely hindered behaviour and 6 indicates highly effective behaviour. Higher scores indicate better team collaboration.
Measured: Immediately after completion of the index operation
C-class distraction count
Number of C-class events per operation, recorded in real time. C-class events are distractions that interrupt operative flow. This is the principal exposure for the primary analysis. A higher count indicates greater observed interruption burden. The minimum is 0 and there is no fixed upper limit.
Measured: During the index operation, from anaesthetic induction to extubation
Total and category-specific distraction counts
Number of A-class (potentially distracting), B-class (visibly distracting the team) and C-class (interrupting operative flow) events per operation, and their total, recorded in real time by the observers. The minimum is 0 and there is no fixed upper limit; higher counts indicate greater distraction burden.
Measured: During the index operation, from anaesthetic induction to extubation
Weighted distraction index
Study-defined score calculated as the number of A-class events plus twice the number of B-class events plus three times the number of C-class events. The minimum is 0, there is no fixed maximum, and higher values indicate greater weighted distraction burden.
Measured: During the index operation, from anaesthetic induction to extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal DiseasesStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Theodoropoulos, National and Kapodistrian University of Athens
- Investigators
- Nikolaos Ntanos, Principal investigator, National and Kapodistrian University of AthensGeorge Theodoropoulos, Study chair, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874412
- Sponsor's protocol ID
- 13751/2026
- Acronym
- ORCHESTRA
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.
PubMed 32843333Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RS. Development and validation of a surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011 Sep;35(9):1961-9. doi: 10.1007/s00268-011-1141-4.
PubMed 21597890Undre S, Sevdalis N, Healey AN, Darzi A, Vincent CA. Observational teamwork assessment for surgery (OTAS): refinement and application in urological surgery. World J Surg. 2007 Jul;31(7):1373-81. doi: 10.1007/s00268-007-9053-z.
PubMed 17487527Hull L, Arora S, Kassab E, Kneebone R, Sevdalis N. Observational teamwork assessment for surgery: content validation and tool refinement. J Am Coll Surg. 2011 Feb;212(2):234-243.e1-5. doi: 10.1016/j.jamcollsurg.2010.11.001.
PubMed 21276535Wheelock A, Suliman A, Wharton R, Babu ED, Hull L, Vincent C, Sevdalis N, Arora S. The Impact of Operating Room Distractions on Stress, Workload, and Teamwork. Ann Surg. 2015 Jun;261(6):1079-84. doi: 10.1097/SLA.0000000000001051.
PubMed 26291954Keogh S, Laski D. A Concern for Intraoperative Distractions and Interference: An Observational Study Identifying, Measuring, and Quantifying Both within the Operating Theatre. Surg Res Pract. 2021 Dec 11;2021:9910290. doi: 10.1155/2021/9910290. eCollection 2021.
PubMed 34931175Ntanos N, Dimakakou K, Pantermaraki M, Filis K, Sigala F, Theodorou D, Chamzin A, Galyfos G. Evaluating Intraoperative Distractions During Surgical Procedures in a University Surgical Department-A Quantitative Analysis. World J Surg. 2025 Dec;49(12):3444-3447. doi: 10.1002/wjs.70174. Epub 2025 Nov 20.
PubMed 41265892
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Intraoperative Distractions, Surgeon Anxiety and Task Load, Team Collaboration, and Intraoperative Adverse Events: The ORCHESTRA Study
- ClinicalTrials.gov ID
- NCT07874412
- Acronym / sponsor ID
- ORCHESTRA / 13751/2026
- Conditions
- Colorectal Diseases, Anal Diseases
- Keywords
- operating room, distractions, surgical flow interruptions, surgeon workload, situational anxiety, teamwork, human factors, colorectal surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Oct 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.
During surgery, telephone calls, conversations, equipment problems and other events may distract the operating team. Some events interrupt the progress of the operation. The surgeon's workload and anxiety, together with how well the team works together, may also be related to events that occur during surgery.
ORCHESTRA is an observational study of patients undergoing colorectal or anal surgery in a single hospital. Trained observers record distractions during routine operations. After each operation, the surgeon reports workload and anxiety, and an observer assesses teamwork. Intraoperative adverse events are graded using a standard severity classification. The study examines how these measurements are related. It does not assign treatments, introduce distractions or change routine surgical care.
Detailed description
ORCHESTRA is a prospective, single-centre observational cohort study conducted in an academic colorectal surgery unit. Consecutive eligible patients undergoing colorectal or anal procedures performed by one designated surgeon are observed during routine surgical care. The operating surgeon and participating theatre staff gave consent to observation and questionnaire assessment at the start of the study.
Two independent observers record naturally occurring distractions in real time, including their type, operative phase and observable impact. Distractions are classified as A, potentially distracting; B, visibly distracting the team; or C, interrupting operative flow. The principal exposure is the number of C-class events per operation. Additional summaries include category-specific counts, total distraction count and a weighted score calculated as A + 2B + 3C.
Intraoperative adverse events are assessed using ClassIntra, with the maximum grade per operation serving as the primary outcome. Immediately after surgery, the operating surgeon completes the study's SURG-TLX implementation and STAI-State. Team collaboration is assessed by the observers using the study's OTAS implementation. Recorded patient and procedure characteristics include age, ASA physical status, obesity, procedure category and operative duration.
Ordinal regression examines associations with increasing ClassIntra severity. Related models consider workload and anxiety together and separately because these measures may be strongly correlated. Additional analyses describe distraction patterns, teamwork, workload and anxiety, and assess more clinically consequential events using a ClassIntra grade II or higher threshold. The study is observational and does not establish causal effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal and anal surgery cohort | – | Other: Naturally occurring operating-room distractions and human factorsConsecutive eligible patients undergoing colorectal or anal surgery performed by the designated surgeon in the participating unit. Naturally occurring distractions, surgeon workload and anxiety, team collaboration and intraoperative adverse events are assessed during the index operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive eligible adult patients undergoing colorectal or anal surgery in the participating unit, performed by the designated surgeon during the study period.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Undergoing a colorectal or anal operation in the participating unit, performed by the designated surgeon, during recruitment.
- Written informed consent.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Naturally occurring operating-room distractions and human factorsObservational recording of naturally occurring distractions and assessment of surgeon workload, situational anxiety and team collaboration during routine surgical care. No experimental exposure is assigned and no change to treatment is prescribed. | Other | Colorectal and anal surgery cohort |
Primary outcome
Intraoperative adverse-event severity assessed by ClassIntra
Time frame: During the index operation, from anaesthetic induction to extubation
The highest ClassIntra grade recorded during the index operation. Grade 0 indicates no intraoperative adverse event; grades I through V indicate increasing severity, with grade V indicating intraoperative death. The case-level ordinal score is analysed in relation to distraction burden and other recorded patient, procedural and human-factor measurements.
7 secondary outcomes
ClassIntra grade II or higher intraoperative adverse event
Time frame: During the index operation, from anaesthetic induction to extubation
Surgeon state-anxiety score
Time frame: Immediately after completion of the index operation
Surgeon task-load score
Time frame: Immediately after completion of the index operation
Observer-rated team collaboration score
Time frame: Immediately after completion of the index operation
C-class distraction count
Time frame: During the index operation, from anaesthetic induction to extubation
Total and category-specific distraction counts
Time frame: During the index operation, from anaesthetic induction to extubation
Weighted distraction index
Time frame: During the index operation, from anaesthetic induction to extubation
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 21 Oct 2026.
- Background: PubMed 32843333Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.
- Background: PubMed 21597890Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RS. Development and validation of a surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011 Sep;35(9):1961-9. doi: 10.1007/s00268-011-1141-4.
- Background: PubMed 17487527Undre S, Sevdalis N, Healey AN, Darzi A, Vincent CA. Observational teamwork assessment for surgery (OTAS): refinement and application in urological surgery. World J Surg. 2007 Jul;31(7):1373-81. doi: 10.1007/s00268-007-9053-z.
- Background: PubMed 21276535Hull L, Arora S, Kassab E, Kneebone R, Sevdalis N. Observational teamwork assessment for surgery: content validation and tool refinement. J Am Coll Surg. 2011 Feb;212(2):234-243.e1-5. doi: 10.1016/j.jamcollsurg.2010.11.001.
- Background: PubMed 26291954Wheelock A, Suliman A, Wharton R, Babu ED, Hull L, Vincent C, Sevdalis N, Arora S. The Impact of Operating Room Distractions on Stress, Workload, and Teamwork. Ann Surg. 2015 Jun;261(6):1079-84. doi: 10.1097/SLA.0000000000001051.
- Background: PubMed 34931175Keogh S, Laski D. A Concern for Intraoperative Distractions and Interference: An Observational Study Identifying, Measuring, and Quantifying Both within the Operating Theatre. Surg Res Pract. 2021 Dec 11;2021:9910290. doi: 10.1155/2021/9910290. eCollection 2021.
- Background: PubMed 41265892Ntanos N, Dimakakou K, Pantermaraki M, Filis K, Sigala F, Theodorou D, Chamzin A, Galyfos G. Evaluating Intraoperative Distractions During Surgical Procedures in a University Surgical Department-A Quantitative Analysis. World J Surg. 2025 Dec;49(12):3444-3447. doi: 10.1002/wjs.70174. Epub 2025 Nov 20.
- Individual participant dataSharing planned: Undecided
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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.
Nikolaos Ntanos principal investigator
National and Kapodistrian University of Athens
George Theodoropoulos study chair
National and Kapodistrian University of Athens
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 Colorectal Diseases and Anal Diseases, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 3 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: looking for participants now, as of the sponsor's last update on 21 Oct 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 Greece. 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 Nikolaos Ntanos (+30 213 208 8000, ntanos.nikos00@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative adverse-event severity assessed by ClassIntra (time frame: During the index operation, from anaesthetic induction to extubation). 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 NCT07874412, which also lists 7 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 21 Oct 2026.