THD GateKeeper^®: indications

The THD GateKeeper^® procedure has proved effective and safe for treating soiling and different types of faecal incontinence which do not respond to pharmacological and conservative treatments. ²

Surgery is assessed case by case according to the symptoms, the severity of the disease and the general health conditions of the patient. Based on clinical evidence and scientific literature, the THD GateKeeper^® method is useful for the treatment of:

• faecal incontinence without sphincter lesions or in the presence of IAS ≤ 90° lesions.
• episodes of faecal incontinence which do not respond to conservative treatments and occur more than once a week. ²
• faecal incontinence associated with rectal prolapse. ³
• faecal incontinence associated with low anterior resection syndrome.¹
• faecal incontinence associated with damage or inhomogeneity of the anal sphincter.⁴

Bibliography:

1. Outcomes of GateKeeper prosthesis implantation for the treatment of fecal incontinence: a multicenter observational study, L. Trenti, S. Biondo, F. Noguerales et al, Techniques in Coloproctology (2017) 21: 963-970.
2. Multicentre observational study of the Gatekeeper^™ for faecal Incontinence, C. Ratto, S. Buntzen et al, BJS 2016; 103: 290–299.
3. Simultaneous Delorme's procedure and inter-sphinteric prosthetic implant for the treatment of rectal prolapse and faecal incontinence: Preliminary experience and literature review, E. Cavazzoni et al, International Journal of Surgery, Available online 9 January 2015.
4. Can GateKeeper, a new bulking agent, be equivalent to SNS in patients with fecal incontinence in the presence of only internal anal sphincter defects?, C. Ratto et al, Tech Coloproct. (2012) 16: 77-110.

THD GateKeeper^®: surgical procedure

 

The THD GateKeeper^® Method is a minimally invasive surgical procedure which involves the insertion of self-expanding prostheses in the inter-sphincter space. The implants are made of biocompatible, non-allergenic, non-immunogenic and non-carcinogenic material.

The surgeon makes small incisions about 2 cm from the anal verge. Through the incision, the surgeon inserts the cannula of the device into the inter-sphincter space, creating a subcutaneous tunnel.

Digital palpation allows the surgeon to locate the inter-sphincter groove and then to insert the device into the inter-sphincter space up to the anorectal junction. Digital palpation allows identification of the tip of the cannula and helping to avoid damaging the tissues.

By using the EAUS probe it is possible to check the position of the cannula tip and then to correctly position the implant.

The self-expanding implant is then released and the cannula is extracted at the end of the implant.

The surgeon closes the incisions with a stitch. The incisions are performed at positions 3, 5, 7, 9, 11 and 1 o’clock.

Once implanted, the prostheses expand by absorbing body fluids and grow in volume up to 550% of their original size. Thanks to the shape memory effect, the implants return to their initial shape and size, supporting the movements of the sphincters. The operation is normally performed under local anaesthesia and lasts an average of 30 minutes.

The advantages of the THD GateKeeper^® method

The THD GateKeeper^® procedure allows the surgical treatment of faecal incontinence, reducing discomfort, invasiveness and pain for the patient. The THD GateKeeper^® method offers long-term results5 with advantages for 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 is indicated for different types of faecal incontinence with or without sphincter lesions (based on the allowed lesion limits).
• no serious intra and post-operative complications ^1,2,4.
• low incidence of dislocation episodes and implant extrusion^1,2.
• reduction of symptoms and significant improvement in quality of life^1,3,5.
• cost-effective: reduced consumption of consumable material and short hospital stay
• simple execution procedure⁶.
• biocompatible, non-allergenic, non-immunogenic and non-carcinogenic implants⁷.

A fast return to daily activities, the absence of serious complications and a good percentage of effectiveness are the main reasons for the high patient satisfaction rate.

Bibliography:

1. 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.
2. Anal Gatekeeper: a new bulking agent for faecal incontinence. B. Fabiani, C. Menconi, I. Giani, G. Naldini, Colorectal Disease, 16 (Suppl. 3), 37-105, V04.
3. Simultaneous Delorme's procedure and inter-sphinteric prosthetic implant for the treatment of rectal prolapse and faecal incontinence: Preliminary experience and literature review, E. Cavazzoni et al, International Journal of Surgery, Available online 9 January 2015.
4. Treatment for faecal incontinence: results of sphincter augmentation with Hyexpan implants in a pilot study. S. Bouassida, K. Krüger, U. Adam, Coloproctology 2015, 37: 26–29.
5. Multicentre observational study of the Gatekeeper™ for faecal Incontinence, C. Ratto, S. Buntzen et al, BJS 2016; 103: 290–299.
6. Can GateKeeper, a new bulking agent, be equivalent to SNS in patients with fecal incontinence in the presence of only internal anal sphincter defects? C. Ratto, A. Parello et al, Tech Coloproctology (2012), 16: 77-110.
7. Injectable and Implantable Agents: current evidence and perspective. C. Ratto, A. Parello, L. Donisi, F. Litta. Management of Fecal Incontinence, M. Mongardini, M. Giofrè (eds.), 2016 pp. 91-105

THD GateKeeper^®: clinical evidence and scientific publications

Today the efficacy and safety of the THD GateKeeper^® procedure is supported by numerous scientific publications containing clinical evidence with medium and long-term follow-ups.

An increasing number of professionals are using the THD GateKeeper^® method and the high level of satisfaction of patients who undergo surgery confirms the quality of the results.

Further information on the scientific literature relating to the THD^® GateKeeper Method is available in the section Clinical Studies.