None listed
Conditions
Brief summary
This is a pilot study of the safety and effectives of the LIFT procedure as a treatment for fistula-in-ano. This study will collect data on patients who have undergone the LIFT procedure looking specifically at the cure rate of the procedure, post-operative sphincter function and complications. The LIFT procedure is a relatively new procedure and it has been reported to be successful at curing fistula in 82-94% of patients with minimal risk of incontinence and thus presents a very attractive alternative in the treatment of fistula-in-ano. However, prior to adaptation into mainstream practice at the Royal Prince Alfred Hospital, it was felt that a pilot study to assess the feasibility and safety of LIFT was necessary.
Interventions
All potential participants will be screened by their respective specialists at their rooms at the time of consultation. Information will be provided for patients who consent to participate in the study. Pre-operative assessment using manometry, endoanal ultrasound and pudendal nerve terminal motor latency will remain unchanged in accordance to our usual practice. Pre-operative assessment of continence will also be carried out using the St. Mark’s continence score as well as Cleveland Clinic cont
All potential participants will be screened by their respective specialists at their rooms at the time of consultation. Information will be provided for patients who consent to participate in the study. Pre-operative assessment using manometry, endoanal ultrasound and pudendal nerve terminal motor latency will remain unchanged in accordance to our usual practice. Pre-operative assessment of continence will also be carried out using the St. Mark’s continence score as well as Cleveland Clinic continence score. As all pre-operative work up of the patient and pre-operative preparation including bowel prep and routine intravenous antibiotic use will remain the same, the only differences for participants of this study are: the type of surgery offered and post operative follow up. The LIFT procedure will be performed using the technique described by Rojanasakul and colleagues. The operation involves a small cut around the anus, identifying the fistula between the 2 anal sphincter muscles and division of this part of the fistula. Patients will be admitted to the hospital on the day of surgery unless otherwise indicated and it is expected that most patients will be discharged within 24-48 hours. On discharge, analgesia and aperients will be prescribed. Follow up will be carried out at 6 weeks, 3, 6 and 12 months post operatively. At each visit, clinical assessment of the fistula tract will be performed. Continence score, manometry and endoanal ultrasound will also be repeated at 3, 6 and 12 months post op to assess sphincter function and to confirm tract closure. In addition to pre-operative assessment and post operative follow up, demographic information, details about previous fistula and failed treatments, concurrent medical conditions will also be collected. Operative notes will also be reviewed to determine duration of operation and intra-operative technical difficulties or complications.
Sponsors
Dr Peter Lee
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) Patients with cryptoglandular or Crohn's fistula ii) Patients deemed inappropriate for fistulotomy or patients with complex fistulae, as defined by recurrent fistula, fistula involving > 30-50% of external sphincter, anterior fistula in a female patient and fistula in a patient with existing incontinence iii) Ability to provide informed consent
Exclusion criteria
Exclusion criteria are: i) Patients with fistula related to pouch surgery ii) Patients who are unable to provide informed consent to participation iii) Patients who are unable to comply with follow up requirements
Outcome results
None listed