Lipogems® Combined with Rectal Flap Surgery Shows Promise for Post-Prostatectomy Fistulas

Abnormal connection between rectum and urethra is rare but serious

A rectourethral fistula (RUF) is an abnormal channel that forms between the rectum and the urethra. This complication can develop after radical prostatectomy (surgery to remove the prostate gland). While rare, it causes distressing symptoms including stool or gas passing through the urinary system. Finding the best repair method has been challenging, with no single approach becoming the standard treatment.

Italian surgeons developed a two-part repair technique

Researchers in Italy created a procedure called RAFAL, which stands for "rectal advancement flap plus adipose lipofilling." This approach repairs the fistula from two directions. On the rectal side, surgeons remove the abnormal tissue and create a flap of healthy rectal lining to cover the opening. On the urethral side, they inject processed fat tissue containing regenerative cells directly around the fistula site.

Seven patients treated over 13-year period

This study followed seven men who developed fistulas after laparoscopic prostate cancer surgery. Key details about these patients:

• Median age was 61 years (ranging from 52 to 66)

• None had received radiation therapy before surgery

• All experienced stool material in their urine within about two weeks after prostatectomy

• Fistula sizes ranged from two to five millimeters

• Each patient first received a temporary colostomy and waited six months for possible natural healing, which did not occur

Lipogems® provided the regenerative cells for injection

For four of the seven patients, surgeons used the Lipogems® device to prepare the regenerative cell solution. The process involved:

• Collecting about 150 milliliters of fat tissue from the patient's abdominal wall

• Processing this tissue through the Lipogems® system for approximately 20 minutes

• Injecting 40 milliliters of the resulting solution around the fistula margins from inside the bladder

The Lipogems® system uses gentle mechanical processing with small stainless steel spheres to separate and concentrate the healing cells found naturally in fat tissue. This creates a ready-to-use product from the patient's own body.

71% success rate with primary procedure, 86% overall

After a median follow-up of 53 months (over four years), results showed:

• Five of seven patients (71%) had complete fistula closure after their first RAFAL procedure

• Two patients experienced fistula recurrence

• One recurrence was successfully treated with a different surgical technique

• The other was successfully treated by repeating the RAFAL procedure

• Overall, six of seven patients (86%) achieved successful closure

• No short-term or long-term complications were observed

• Blood loss during surgery was minimal (less than 50 milliliters in all cases)

A minimally invasive option for a difficult problem

The researchers concluded that this combined approach was both safe and effective for their patients. The RAFAL technique offers several potential advantages. It addresses the fistula from both the rectal and urethral sides simultaneously. It uses the patient's own tissue, avoiding donor material. The Lipogems® processing takes only about 20 minutes, making it practical for use during surgery.

While this study involved only seven patients, the long follow-up period (some patients tracked for over 13 years) provides meaningful information about lasting results. For men facing this challenging complication after prostate surgery, this technique represents a promising treatment option that combines established surgical repair with regenerative medicine.

---

Source: Zuin et al., Techniques in Coloproctology, 2019.