CIRCLIST - Ali's Klamp

The Basics
The Ali’sKlamp was first marketed in 2007 as a disposable male circumcision device designed for circumcising aesthetically, quickly, without blood loss and without the use of sutures. In 2013 the Turkish manufacturer, ABA Group, announced a series of significant design changes in consequence of which the product was re-launched under the brand name NeoAlisklamp. However, the revised version is now just known as the Alisklamp.

In both versions the clamp is delivered in two parts, a transparent polycarbonate tube and a white plastic clamping mechanism. It achieves circumcision by means of crushing the foreskin between the two components. Excess tissue is removed using a scalpel, but that cut does not define the eventual scar line; the scalpel cut merely disposes of what would otherwise become a mass of necrotic tissue. The final scar line forms beneath the clamping ring. This process, which in essence involves the forcing of scar formation beneath a crushing ring, was first used for the purposes of circumcision by the Tara KLamp (another clamp-and-wear device which pre-dates the Ali’sKlamp by about 12 years).

The original Ali’sKlamp looked very similar to the original SmartKlamp but differed in one important respect: The clamping ring was angled with respect to the longitudinal axis of the device. That design feature naturally aligns the circumcision scar with the rim of the glans (the corona).

Photo-comparison of theoriginal Ali’sKlamp and revised Alisklamp (Manufacturer’s Photographs)

Availability
Supply is restricted to members of the medical profession who have been trained in its use. Training is normally available in Turkey and the UK, elsewhere by arrangement. The clamp is produced in sizes suitable from infants (10mm) to adult (34mm).

Reported use

Correspondence received from the manufacturer indicates that by January 2012 the clamp was being marketed in Turkey, the UK, Germany, The Netherlands, France, Switzerland, Malaysia, Indonesia, Singapore, Iran, Iraq, Pakistan, Azerbaijan, Turkmenistan, the United Arab Emirates, Egypt, New Zealand and Saudi Arabia. Additionally, in adult sizes only, it has been trialled in Kenya as part of the campaign of mass circumcision aimed at limiting the spread of HIV.

Results obtained
The following images have been supplied to Circlist by the manufacturer and are reproduced here with their permission, but remain copyright of the manufacturer’s parent company, ABA Group. They were from the original (2007) design.

Field Trial reports

The Alisklamp has been the subject of a number of large-scale, published trials. Here is the abstract of the most recent, which frankly reads like a promo fot the device. It comes from Saudi Arabia, where circumcision (unlike Turkey) is commonly performed in the first year of life.

Safety, acceptability, and feasibility of male circumcision using the alisklamp device
Madani Essa, Department of Surgery, College of Medicine, Jazan University, Jazan, Saudi Arabia.
J Pediatr Urol 2022 Sep 27;S1477-5131(22)00378-3. doi: 10.1016/j.jpurol.2022.09.013.

Greater than 20 surgical circumcision devices are available worldwide for male circumcision. These have been developed so as to decrease complications. The hemostasis system classifies these devices as crush, clamp or ligature. This study assessed the safety, acceptability, and feasibility of male neonatal circumcision using the Alisklamp device (AKD). The AKD is one of the latest medical devices designed for assisted circumcision. It takes less time to install, has a better complication rate, and has a better cosmetic appearance than conventional surgical circumcision. The study was divided into two sections: assessing the safety of the AKD and evaluating parents' satisfaction. Convenience sampling was used in this study. In the first section, a form was filled by operating pediatric surgeon for children whose parents agreed to participate in the study. In the second section, a total of 100 male children were included in the study based on the sample size guidelines of the World Health Organization. The circumcision was performed by an experienced pediatric surgeon following the manufacturer's instructions. The procedures were completed without AKD failure or unwelcome preputial loss. The results showed that 63.54% of the children were circumcised in their first four weeks of life. About 60.42% of the procedures were completed within 5-10 min. Also, 95.83% of the children had no postoperative complications. Further, 90.63% of parents were satisfied with the AKD and willing to recommend it to others. During the follow-up, all of the children's parents were pleased with the cosmetic and final results of the AKD. In conclusion, the AKD has an outstanding protection profile suitable for male circumcision procedures.

Older reports

Here is the Abstract of the report that appeared in Pediatr Surg Int. 2010 Jun 8. [Epub ahead of print]:

Minimally invasive circumcision with a novel plastic clamp technique: a review of 7,500 cases. Senel FM, Demirelli M, Oztek S.

Dr. Sami Ulus Children’s Hospital, Ankara, Turkey.

PURPOSE: We aimed to analyze the outcome of circumcisions performed with a new minimally invasive circumcision device. METHODS: This is the first study, which reports the results of 7,500 children circumcised with minimally invasive technique utilizing a plastic clamp device (Ali’s Clamp ®) in our country. The results of this technique are compared to those of 5,700 children who underwent conventional circumcision.

RESULTS: The most common complication encountered after minimally invasive circumcision technique was found to be buried penis (1.04%). The second complication observed was infection (0.6%), which was significantly lower than the conventional group (p < 0.001). The third complication in plastic clamp group was bleeding with a rate of 0.4%. Bleeding was found to be the most common complication seen after conventional circumcision (5%) and was significantly higher than that of the plastic clamp group (p < 0.001). Total number of complications seen after plastic clamp technique was 2% when compared with 10.4% complication rate occurred after conventional circumcision (p < 0.001). The mean duration of circumcision time with plastic clamp technique was 4.5 ± 1.5 minutes whereas with conventional circumcision it was 23 ± 4 minutes (p < 0.0001).

CONCLUSION: Minimally invasive circumcision technique utilizing plastic clamp significantly reduced the complication rates. The cosmetic appearance after circumcisions performed with this technique was observed to be better than the conventional circumcisions. Due to reduced complications, as well as short duration and ease of application, the minimally invasive technique is suggested as the circumcision procedure of choice.

PMID: 20532526 [PubMed].

CIRCLIST Editor’s note:

This article appears to mis-use the term Buried Penis. In the full article, the authors define it as "healing of wound edges above the glans penis... causing a constrictive ring at this level resulting in phimosis", a matter unrelated to any issue involving a short suspensory ligament within the abdomen. A better term for the problem they seek to describe might be "Induced phimosis resulting from scar line constraint" - after initial definition shortened to just "scar line constraint".

Further trial reports appear in:

Urology 78(1), 2011 pp174-179

The Journal of Urology, Vol.186 1923-1927 Nov 2011. Click this link for the PubMed abstract, or click here for access to the full text.

Urology Journal Vol.9 No.3. Summer 2012. pp.701-706 Adult Male Circumcision Performed with Plastic Clamp Technique in Turkey - Results and Long-Term Effects on Sexual Function. Senel FM, Demirelli M, Misirlioglu F, Sezgin T. This illustrated study reports a long-term follow-up of men circumcised as adults with the Ali'sKlamp, concentrating on issues of pre- and post-circumcision sexual functions. Such longer-term follow-ups are rare and often under-reported; you can read the full text here.

J Pediatr Urol. 2012 Sep 6. Comparison of local anesthetic effects of lidocaine versus tramadol and effect of child anxiety on pain level in circumcision procedure. Polat F, Tuncel A, Balci M, Aslan Y, Sacan O, Kisa C, Kayali M, Atan A. Gazi University School of Medicine, Department of Urology, Ankara, Turkey. The PubMed link to this study is:
http://www.ncbi.nlm.nih.gov/pubmed/22959557.

Want to know more?

Click here to download a 16-page brochure produced by the manufacturer (.pdf format, English language text), last updated March 2012.

Further information in four languages (Turkish, English, German and Arabic) is available on the manufacturer’s website http://www.alisklamp.com/.

•		Lighter in weight by ⅓.
•		Sizes over 20mm diameter smaller by ⅓.
•		Tighter grip at the clamping ring, with consequent reduction in wear time.
•		Automated detachment, rendering a second visit to the clinic unnecessary. Consequent major savings in clinic time and patient’s travelling costs.
•		Lower infection risk through use of antibacterial plastics.
•		V-Scar produced by new shape of clamping ring.
•		Improved locking mechanism, guarding against both premature removal by a meddlesome patient and unscrupulous re-use of a discarded clamp.
•		Fitting procedure optionally allows pre-assembly into a single unit before application to the penis, with consequent time saving.
•		Automated setting of the quantity of retained inner foreskin shortens the procedure and eliminates the risk of an uneven scar line.
•		Improved alignment of urinary meatus.
•		Less residual necrotic tissue (now typically 1.5mm)


The original (2007) Ali’sKlamp	The 2013 NeoAlisklamp	The two versions side-by-side

Appearance of scar line in a child patient

Two photographs of the same boy, age 8 years 4 months at circumcision, 25 days after the Ali’sKlamp was applied. Click the images to enlarge. Use the Back button of your browser to return to this page. Motivation for circumcision: Religious obligation.

Tight styles of circumcision in child patients

Left: A boy age 9 years 2 months at circumcision, 15 days after the Ali’sKlamp was applied. Right: A boy age 5 years 6 months at circumcision, 17 days after the Ali’sKlamp was applied. Click the images to enlarge. Use the Back button of your browser to return to this page. For reasons associated with Turkish cultural norms, no ‘before’ photographs exist of these patients. Motivation for circumcision: Religious obligation.

Trial results - The Ali’sKlamp in adult sizes

Patients in the 18-49 age group, shown here 2 and 44 days after the clamp was applied. Click the images to enlarge. Use the Back button of your browser to return to this page. Motivation for circumcision: Public health campaign / HIV prophylaxis.