Postoperative bowel adhesions following laparoscopic urologic pelvic surgery: a prospective, randomized, controlled, single-blind study
Jun Sung Koh, U-Syn Ha, Sung Hoo Hong, and Ji Youl Lee
Dept. of Urology, The Catholic University of Korea
To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose (HA/CMC) following laparoscopic radical prostatectomy
- Men who were 50-75 years old and diagnosed with prostate cancer were eligible if they were scheduled to undergo laparoscopic radical prostatectomy.
- Exclusion criteria: included any history of abdominal or pelvic surgery, hypersensitivity or an allergic reaction to the study material, pelvic lymph node dissection at the same time as prostatectomy, the presence of surgical site infection or contamination, a history of a medical disease causing bowel adhesion, or a history of severe drug allergies.
Materials and Methods:
-60 Men who underwent laparoscopic radical prostatectomy between November 2011 and June 2014.
the HA/CMC treatment group (n = 30)
the control group (n=30)
- The surgeon was blinded to treatment assignments before randomization. Patients were also blinded to their treatment group throughout the study.
- HA/CMC was applied in all port sites and the peritoneal incision line of the medial umbilical ligament with a single-use applicator attached to a sprayer that allowed for the precise application to the required sites (Fig. 1).
- Viscera slide ultrasound and plain X-ray were recorded at the time of the operation (V0) and 12 (V1) and 24 week (V2) after the operation.
- By dividing the abdomen into 5 segments and examining the viscera slide in each segment, a prediction of the extent of the adhesions was made for each patient (Fig. 2).
- Restricted viscera slide: defined as less than 1 cm of longitudinal movement during both normal and exaggerated respiration.
- The primary end point: the difference in excursion distance on viscera slide ultrasound between V0 and V2.
The secondary end point: excursion distance on viscera slide ultrasound at V2 and the presence of restriction of viscera slide on ultrasound at V2.
- A total of 60 patients who diagnosed with prostate cancer were enrolled and 50 patients completed this study.
- None of patients showed adverse events associated with the use of hyaluronic acid-carboxymethylcellulose (HA/CMC).
- This randomized study provided preliminary data demonstrating that HA/CMC treatment resulted in a reduction in bowel adhesion to the abdominal wall after laparoscopic pelvic surgery with good clinical safety.