Objectives. Laser tissue soldering (LTS) in the urinary tract provides
an immediate leak-free seal and may avoid complications seen with con
ventional repair (such as fistula and stricture). We have begun a Phas
e I clinical trial investigating the use of LTS in performing urologic
reconstructive surgery. Methods. Ten patients (aged 3 months to 38 ye
ars) underwent urologic reconstruction using LTS with a protein solder
composed of human albumin (42%) and indocyanine green dye. In each ca
se standard microsuture repair preceded laser-soldered suture line rei
nforcement. Anastomotic closure time and immediate leak pressure were
measured, Postoperatively, all patients were evaluated for evidence of
complications, including stricture, fistula formation, or impaired he
aling. Results. Using LTS as an adjunct to suturing added an average o
f 7.9 +/- 3.0 minutes (28%) to the overall mean anastomotic time of 28
.3 +/- 9.4 minutes. Intraoperative leak pressure measurements for lase
r-soldered anastomoses (greater than or equal to 94.2 +/- 24.2 mm Hg)
were significantly higher (P < 0.001) than primarily sutured anastomos
es (20 +/- 2.9 mm Hg). Two instances of suture disruption (20%) occurr
ed during laser activation, neither of which were repaired with suture
s. Average follow-up for all patients was 7.1 +/- 2.2 months. There we
re no intraoperative or postoperative complications, including the 2 p
atients with suture disruption. Conclusions. These initial clinical re
sults indicate that LTS is safe, easy to perform, and, contrary to con
ventional suturing, provides an immediate leak-free closure. Follow-up
in these and other patients, as well as those undergoing sutureless a
nd stent-free procedures, will determine whether our method of LTS ben
efits patients undergoing urologic reconstruction.