Trial Outcomes & Findings for Colonoscopy Check-up in People With Lynch Syndrome (NCT NCT06126120)
NCT ID: NCT06126120
Last Updated: 2026-06-05
Results Overview
Participant non-adherence to 2-yearly colonoscopy check-up was assessed using data from the national Hospital Episode Statistics (HES) database. Non-adherence was calculated based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies, depending on data availability, and the interval between participants' most recent check-up colonoscopy and questionnaire completion. Colonoscopy data recorded between December 1995 (when the earliest colonoscopy was recorded in the HES extract) and April 2024 (the final month in which participants completed the questionnaire) were used. Participant non-adherence was reported as a percentage.
COMPLETED
231 participants
Up to approximately 13 years (median 5 years), based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies and the interval between participants' most recent check-up colonoscopy and questionnaire completion.
2026-06-05
Participant Flow
Participants were recruited from the Lynch syndrome research registry pilot between 17 January 2024 and 4 April 2024.
Of the 257 people in the registry pilot, seven were excluded at the initial participant eligibility assessment. The remaining 250 people were invited to take part in the present study, of whom 19 were subsequently excluded, either because the investigators were informed after invite that they met the exclusion criteria or because they did not respond to the questionnaire. This left 231 participants (92% of invitees). Participants were not assigned to any group or intervention.
Participant milestones
| Measure |
All Study Participants
All participants with Lynch syndrome included in the present study
|
|---|---|
|
Overall Study
STARTED
|
231
|
|
Overall Study
COMPLETED
|
231
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Colonoscopy Check-up in People With Lynch Syndrome
Baseline characteristics by cohort
| Measure |
All Study Participants
n=231 Participants
All participants with Lynch syndrome included in the present study
|
|---|---|
|
Age, Customized
Age group · 25-44 years
|
40 Participants
n=20 Participants
|
|
Age, Customized
Age group · 45-64 years
|
123 Participants
n=20 Participants
|
|
Age, Customized
Age group · ≥65 years
|
68 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White British
|
220 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
11 Participants
n=20 Participants
|
|
Site
A
|
55 Participants
n=20 Participants
|
|
Site
B
|
60 Participants
n=20 Participants
|
|
Site
C
|
79 Participants
n=20 Participants
|
|
Site
D
|
37 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 13 years (median 5 years), based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies and the interval between participants' most recent check-up colonoscopy and questionnaire completion.Population: The number here differs from the total number of participants because only those who had a past/current cancer recorded in national cancer registry data were included in the analysis of non-adherence with 2-yearly colonoscopy check-up; data on check-up colonoscopies from the HES database were available only for these participants. Additionally, participants had to have had at least 2 recorded check-up colonoscopies to be included in this analysis.
Participant non-adherence to 2-yearly colonoscopy check-up was assessed using data from the national Hospital Episode Statistics (HES) database. Non-adherence was calculated based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies, depending on data availability, and the interval between participants' most recent check-up colonoscopy and questionnaire completion. Colonoscopy data recorded between December 1995 (when the earliest colonoscopy was recorded in the HES extract) and April 2024 (the final month in which participants completed the questionnaire) were used. Participant non-adherence was reported as a percentage.
Outcome measures
| Measure |
Participants Included in the Analysis of Non-adherence With 2-yearly Colonoscopy Check-up
n=110 Participants
Only participants who had a cancer diagnosis recorded in national cancer registry data were included in the analysis of non-adherence with 2-yearly colonoscopy check-up; data on check-up colonoscopies from the HES database were available only for these participants. Additionally, participants had to have had at least 2 recorded check-up colonoscopies to be included in this analysis. The number of included participants is reported as 110, rounded to the nearest 5 in line with statistical disclosure control requirements for HES data. As HES requires suppression of cell counts below 8, exact counts cannot be reported here because they could enable derivation of a value below this threshold when combined with data reported in other study outputs, such as the study manuscript. Therefore, the number of included participants and the counts of adherent and non-adherent participants were rounded to the nearest 5. Percentages were calculated from these rounded counts.
|
|---|---|
|
Participant Non-adherence to 2-yearly Colonoscopy Check-up.
Number of Adherent Participants
|
95 Participants
|
|
Participant Non-adherence to 2-yearly Colonoscopy Check-up.
Number of Non-adherent Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: At time of questionnaire (1 day)The 4 most important challenges to having colonoscopy check-up were identified using participants' responses in the questionnaire. The questionnaire asked participants to select up to 4 challenges they considered most important from a given list of 41 challenges. The 4 challenges most frequently selected by participants were considered the most important. The results show, for each challenge, the number and proportion of participants who selected it as one of their biggest challenges. As participants could select more than one challenge, the counts and percentages for individual challenges do not sum to the total number of participants and 100%, respectively.
Outcome measures
| Measure |
Participants Included in the Analysis of Non-adherence With 2-yearly Colonoscopy Check-up
n=231 Participants
Only participants who had a cancer diagnosis recorded in national cancer registry data were included in the analysis of non-adherence with 2-yearly colonoscopy check-up; data on check-up colonoscopies from the HES database were available only for these participants. Additionally, participants had to have had at least 2 recorded check-up colonoscopies to be included in this analysis. The number of included participants is reported as 110, rounded to the nearest 5 in line with statistical disclosure control requirements for HES data. As HES requires suppression of cell counts below 8, exact counts cannot be reported here because they could enable derivation of a value below this threshold when combined with data reported in other study outputs, such as the study manuscript. Therefore, the number of included participants and the counts of adherent and non-adherent participants were rounded to the nearest 5. Percentages were calculated from these rounded counts.
|
|---|---|
|
The 4 Most Important Challenges to Having Colonoscopy Check-up for Participants.
'I have trouble drinking the laxative solution because of the volume of liquid'
|
45 Participants
|
|
The 4 Most Important Challenges to Having Colonoscopy Check-up for Participants.
'I have trouble drinking the laxative solution because of the taste'
|
56 Participants
|
|
The 4 Most Important Challenges to Having Colonoscopy Check-up for Participants.
'I worry about the results I might get'
|
45 Participants
|
|
The 4 Most Important Challenges to Having Colonoscopy Check-up for Participants.
'I feel anxious when I think about having a colonoscopy'
|
37 Participants
|
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place