Water assisted flexible sigmoidoscopy in NHS Bowel Scope Screening Programme

The WASH study: water assisted sigmoidoscopy in NHS Bowel Scope Screening Programme: a randomised multicentre study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81466870

Enrollment

1100

Registered

2018-04-12

Start date

2017-12-01

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other examination or investigation Digestive System

Interventions

Patients will be randomised using a secure, web-based platform that can be accessed 24 hours a day, which was developed and is maintained by NWORTH. The randomisation uses dynamic allocation to ensure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Referral for screening flexible sigmoidoscopy via the NHS Bowel Scope Screening Programme 2. Ability to give informed consent

Exclusion criteria

Exclusion criteria: 1. Absolute contraindications to sigmoidoscopy 2. Patients lacking capacity to give informed consent 3. Previous left colonic/rectal resection 4. Ongoing antithrombotic treatment (apart from aspirin, which is permitted)

Design outcomes

Primary

Measure	Time frame
Pain is measured using a standard Likert scale (4-point) (“None/ Mild / Moderate / Severe”) post-procedure/pre-discharge and 24 hours afterwards via patient questionnaire	—

Secondary

Measure	Time frame
The key secondary outcome will be the adenoma detection rate (ADR), the key performance indicator for the accuracy of sigmoidoscopy in detecting pre-malignant polyps (adenomas). This is measured at 14 days following review of all histology reports of patient who have polyps removed Other secondary measures include: 1. Procedural pain as rated by patients on a Visual Analogue Scale (VAS) immediately after procedure [post-procedure, pre-discharge] 2. Other aspects of patients’ experience, by a post-discharge questionnaire assessing embarrassment, willingness to repeat the procedure, expected versus experienced pain, overall satisfaction and symptoms post-procedure. 3. The sigmoidoscopy insertion times (SITs) 4. The sigmoidoscopy withdrawal times (SWTs) in negative procedures (i.e. without polyps) 5. The maximum extent of insertion (segment, i.e. rectum, distal sigmoid, proximal sigmoid, distal descending, proximal descending, splenic flexure, distal transverse; as judged by the endoscopist) – this will be the primary means to estimate extent of insertion 6. The final length of scope inserted just prior to withdrawal (scope length in cm) – this will be used as a surrogate for how straight/looped the scope is (stratifying by segment extent) 7. The mean number of adenomas per procedure (MAP) 8. The percentage of procedures where Entonox was used on demand (i.e. as an adjunct in case of procedural pain per patient’s wish). This will not be applicable in procedures where participants prefer to start their procedure with Entonox use 9. The quality of mucosal views on withdrawal using the validated Boston Bowel Preparation Scale 10. The percentage of procedures where a second enema was needed (due to poor mucosal views) 11. The percentage of procedures where hand pressure was required	—

Measure

Time frame

The key secondary outcome will be the adenoma detection rate (ADR), the key performance indicator for the accuracy of sigmoidoscopy in detecting pre-malignant polyps (adenomas). This is measured at 14 days following review of all histology reports of patient who have polyps removed Other secondary measures include: 1. Procedural pain as rated by patients on a Visual Analogue Scale (VAS) immediately after procedure [post-procedure, pre-discharge] 2. Other aspects of patients’ experience, by a post-discharge questionnaire assessing embarrassment, willingness to repeat the procedure, expected versus experienced pain, overall satisfaction and symptoms post-procedure. 3. The sigmoidoscopy insertion times (SITs) 4. The sigmoidoscopy withdrawal times (SWTs) in negative procedures (i.e. without polyps) 5. The maximum extent of insertion (segment, i.e. rectum, distal sigmoid, proximal sigmoid, distal descending, proximal descending, splenic flexure, distal transverse; as judged by the endoscopist) – this will be the primary means to estimate extent of insertion 6. The final length of scope inserted just prior to withdrawal (scope length in cm) – this will be used as a surrogate for how straight/looped the scope is (stratifying by segment extent) 7. The mean number of adenomas per procedure (MAP) 8. The percentage of procedures where Entonox was used on demand (i.e. as an adjunct in case of procedural pain per patient’s wish). This will not be applicable in procedures where participants prefer to start their procedure with Entonox use 9. The quality of mucosal views on withdrawal using the validated Boston Bowel Preparation Scale 10. The percentage of procedures where a second enema was needed (due to poor mucosal views) 11. The percentage of procedures where hand pressure was required

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026