None listed
Conditions
Brief summary
The Relax Study will test whether Botox injection into the anal sphinceters and pelvic floor during standard surgery can improve healing and symptoms for people with complex perianal fistula. Botox briefly relaxes the anal muscles, which may support recovery. Participants will receive surgery with or without Botox and will report on their symptoms afterward. We hypothesize that Botox will lead to better symptom improvement and healing at three months.
Interventions
All participants will complete a baseline PROCTOPROM questionnaire and undergo routine clinical and radiological assessment to classify their disease as a part of their operative planning.
During surgery, the modality of sphincter sparing surgery will remain as per the surgeon’s choice for all participants. Alongside surgery, the intervention group will receive a total of 100U Botox reconstituted into 1ml of saline. This will be injected as 50IU into puborectalis and 50IU in the intersphincter
All participants will complete a baseline PROCTOPROM questionnaire and undergo routine clinical and radiological assessment to classify their disease as a part of their operative planning. During surgery, the modality of sphincter sparing surgery will remain as per the surgeon’s choice for all participants. Alongside surgery, the intervention group will receive a total of 100U Botox reconstituted into 1ml of saline. This will be injected as 50IU into puborectalis and 50IU in the intersphincteric plane, under the guidance of a consultant surgeon with expert understanding of the regional anatomy. The use and the method will be recorrected in the operation note. Post operative intervention will remain at the surgeon’s discretion for both the control and intervention arms. At 3 months (as per established departmental protocol), the participant will be assessed by an extended PROCTOPROM and outpatient clinical assessment.
Sponsors
Queen Elzabeth II Jubilee Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• All consenting adults over the age of 18 years who have a perianal fistula that are put forward for sphincter sparing surgery. • Participants may have had previous attempts of repair.
Exclusion criteria
• Those who are unwilling or not able to complete the PROCTOPROM questionnaire despite appropriate help. • Aetiology due to Inflammatory Bowel Disease, Hidradenitis suppurative or malignancy. • Anorectal-vaginal fistulae. • Immunosuppressed. • Known collagen or generalised musculoskeletal disease. • Known adverse events from Botox (including hypersensitivity, myasthenia gravis and Eaton Lambert Syndrome.) • Those who do not consent to participate.
Outcome results
None listed