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The Effect of Guardix-solution for the Prevention of Postoperative Intestinal Adhesion and Intestinal Obstruction After Laparoscopic Pelvic Cavity Surgery

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ClinicalTrials.gov Identifier: NCT02773251
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Koh Jun Sung, Bucheon St. Mary's Hospital

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Postoperative Adhesion Drug: hyaluronic acid-carboxymethylcellulose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hyaluronic Acid-Carboxymethylcellulose Reduced Postoperative Bowel Adhesions Following Laparoscopic Urologic Pelvic Surgery: a Prospective, Randomized, Controlled, Single-Blind Study
Study Start Date : November 2011
Actual Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: hyaluronic acid-carboxymethylcellulose treatment group
the HA/CMC treatment group after laparoscopic pelvic surgery
Drug: hyaluronic acid-carboxymethylcellulose
No Intervention: control group
the HA/CMC non-treatment group after laparoscopic pelvic surgery



Primary Outcome Measures :
  1. the difference in excursion distance on viscera slide ultrasound between V0 and V2. [ Time Frame: within the first 6 months after surgery ]


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men who were 50-75 years old and diagnosed with prostate cancer were eligible if they were scheduled to undergo laparoscopic pelvic surgery (radical prostatectomy).

Exclusion Criteria:

  • 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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Koh Jun Sung, Professor, Bucheon St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02773251    
Other Study ID Numbers: XC11DIMI10098H
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Keywords provided by Koh Jun Sung, Bucheon St. Mary's Hospital:
Postoperative adhesion
Laparoscopy
Adhesion barrier
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Carboxymethylcellulose Sodium
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Laxatives
Gastrointestinal Agents