THD SphinKeeper®: indications
THD SphinKeeper® is a new minimally invasive surgical treatment for faecal incontinence. This technique is suitable for different forms of anal incontinence. The clinical evidence and the scientific literature demonstrate the efficacy of the THD SphinKeeper® procedure in the treatment of:
- episodes of faecal incontinence (passive, urgent or mixed) which occur more than once a week and do not respond to conservative treatments.
- faecal incontinence associated with urinary incontinence.
- faecal incontinence associated with previous radiotherapy treatments in the pelvic area.
- faecal incontinence associated with previous surgical procedures for the treatment of faecal incontinence (sphincteroplasty, SNS).
- faecal incontinence associated with previous anal surgery.
The surgeon will evaluate whether surgery is advisable based on the symptoms, the type of incontinence and the patient's health conditions.
- Outcomes of Implantation of SphinkeeperTM: a new artificial anal sphincter, C. Ratto, L. Donisi et al., Techniques in Coloproctology 2016; 20: 59-66
THD SphinKeeper®: surgical procedure
THD SphinKeeper® allows faecal incontinence to be treated by restoring sphincter function through the placement of special self-expanding prostheses into the inter-sphincteric space. The THD SphinKeeper® operation involves the implantation of 10 self-expanding sterile prostheses between the internal and the external sphincter, thus creating a sort of third ring around the circumference of the anal canal. These prostheses increase in volume by absorbing body fluids resulting in the consequent recovery of continence.
The implants are made of a material with a shape memory, biocompatible, non-allergenic, non-immunogenic and non-carcinogenic.
As with the THD GateKeeper® procedure, surgery can be performed under local anaesthesia; the surgeon will male small incisions about 2 cm from the anal verge inside which he inserts the prostheses with a specific delivery system. The cannula of the device is subsequently inserted into the inter-sphincter space and the prostheses are released.
With ultra sound guidance, the surgeon can monitor the progress of the operation and ensure correct positioning of the implant.
At the end of the operation the surgeon sutures the skin incisions. The incisions are performed at positions 1, 5, 4, 9, 10, 6, 8, 7, 2 and 3 o’clock. The operation is normally performed under general anaesthesia in the UK and lasts an average of 40 minutes.
Within 48 hours of implantation, the shape memory prostheses expand by absorbing body fluids and grow in volume up to 730% of their original size.
The advantages of the THD SphinKeeper® procedure
The minimally invasive THD SphinKeeper® procedure allows surgical restoration of anal continence with minimal discomfort for the patient. The THD SphinKeeper® is suitable for forms of faecal incontinence of different aetiology offering numerous advantages for the surgeon and patient:
- minimally invasive procedure: it preserves anorectal physiology with a short hospitalisation time and reduced post-operative pain and bleeding.
- extensive indications for the operation: the procedure can be used for treating different types of faecal incontinence, even after other operations in the anorectal area.
- no serious intra and post-operative complications.
- low incidence of dislocation episodes and implant extrusion.
- reduction of symptoms and significant improvement in quality of life.
- cost-effective: reduced consumption of consumable material and short hospital stay.
- simple execution procedure.
- biocompatible, non-allergenic, non-immunogenic and non-carcinogenic implants.
Patients who undergo this procedure can benefit from a fast return to normal activities, the absence of serious intra and post-operative complications and a good percentage of effectiveness.
- Implantation of Sphinkeeper: a new artificial anal sphincter. C. Ratto, L. Donisi, F. Litta, P. Campennì, A. Parello, Tech Coloproctol. 2016; 20: 59-66.
THD SphinKeeper®: clinical evidence and scientific publications
The type of prosthesis used during the THD SphinKeeper® procedure is similar to that used for THD GateKeeper® procedure.
Further information on the scientific literature relating to the THD SphinKeeper® Procedure is available in the section Clinical Studies.
- Efficacy of Sphinkeeper implantation in faecal incontinent patients: 1-year experience. C. Ratto, L. Donisi, A. Parello, F. Litta, Colorectal Disease, Vol. 18, Suppl. 1, September 2016.
- Injectable and Implantable Agents: Current Evidence and Perspective. C. Ratto, A. Parello, L. Donisi, F. Litta. Management of Fecal Incontinence, Springer International Publishing Switzerland 2016, p. 91-105
- Novel bulking agent for faecal incontinence. C. Ratto, A. Parello, L. Donisi, F. Litta et al, British Journal of Surgery 2011 Nov; 98 (11): 1644-52.