The Effect of Guardix-solution for the Prevention of Postoperative Intestinal Adhesion and Intestinal Obstruction After Laparoscopic Pelvic Cavity Surgery
Condition: Prostate Cancer; Postoperative Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose
      following laparoscopic pelvic surgery (radical prostatectomy).
    

Detailed description: 
      Methods This was a prospective, randomized, controlled, single-blind, parallel-group study
      using HA/CMC (marketed as Guardix-sol®, Hanmi Medicare, Seoul, Korea) in patients who
      underwent laparoscopic radical prostatectomy between November 2011 and June 2014. All the
      patients were informed in detail about the aims and the procedures of the study and they
      signed a written informed consent prior inclusion into the study. The protocol and the
      written informed consent were approved by the local ethical committee (Catholic Medical
      Center, Clinical Research Coordinator Center; approval number XC11DIMI10098H).

      Subjects 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.

      Study design and protocol The laparoscopic radical prostatectomy was performed in same
      surgical procedures and steps by two surgeons (USH and JSK) who have experienced over 150
      cases of laparoscopic radical prostatectomy. The laparoscopic radical prostatectomy was
      performed using the five-port fan-shaped transperitoneal approach. After the introducing the
      peritoneal cavity, incising the parietal peritoneum between the medial umbilical ligaments
      are incised and dissection is carried through the fatty alveolar tissue to develop the space
      of Retzius. After that, the surgical steps are following order (1) incision of the endopelvic
      fascia; (2) ligation of the dorsal vein complex; (3) division of the bladder neck; (4)
      dissection of the seminal vesicles; (5) incision of the Denonvillier fascia and control of
      the lateral pedicles with antegrade neurovascular bundle dissection; (8) apical dissection
      and division of the dorsal vein and the urethra; (9) urethrovesical anastomosis.

      Considering about 30% of dropout rate (under the assumption of 40% difference between HA/CMC
      treatment group and the control group based on previous similar study, by which the target
      enrollment for this trial was 60 subjects (30 subjects per group). The sample size was
      determined assuming a level of significance of α=0.05 (two-side) and a 80% statistical power
      of test. All patients were randomly assigned to either the HA/CMC treatment group (n=30) or
      the control group (n=30) using a computer-generated randomization table. 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. The amount of HA/CMC
      applied was 5 ml. Information regarding the duration of illness and medical history were
      collected at the time of enrollment (V0). 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.

      The primary end point was the difference in excursion distance on viscera slide ultrasound
      between V0 and V2. The secondary end point was excursion distance on viscera slide ultrasound
      at V2 and the presence of restriction of viscera slide on ultrasound at V2.

      Assessment of efficacy and safety Twelve and 24 weeks after the operation, bowel adhesion to
      the abdominal wall was evaluated by ultrasound and plain X-rays. We performed viscera slide
      ultrasound according to a technique that has been previously described. 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. At the time of the viscera slide
      ultrasound, data were also collected on the location of the scars on the abdomen. The main
      point of interest was the distance of the longitudinal excursion of the selected area in
      relation to the fixed abdominal wall. Normal viscera sliding movement was defined as equal to
      or greater than 1 cm of longitudinal movement. Restricted viscera slide was defined as less
      than 1 cm of longitudinal movement during both normal and exaggerated respiration. The
      ultrasound was performed by two sonographers who had been well instructed for study
      assessment. The assessment by ultrasound was double-checked. The sonographer, radiologist and
      all accessor was blind to the randomization during the all study period.

      Statistical Analysis The data for this study are expressed as mean ± standard deviation of
      the mean. The comparisons of the 2 groups were made using a chi-test, an independent
      Student's t test, or repeated measure ANOVA. P-values <0.05 were considered significant.
      Statistical calculations were carried out with IBM SPSS statistics, Version 21 (IBM Corp,
      Armonk, NY).
    

Intervention name(s): hyaluronic acid-carboxymethylcellulose
Intervention type(s): Drug
Intervention MeSH terms: Carboxymethylcellulose Sodium; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postoperative adhesion; Laparoscopy; Adhesion barrier