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
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Sponsor:
Bucheon St. Mary's Hospital
Information provided by (Responsible Party):
Koh Jun Sung, Bucheon St. Mary's Hospital
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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 |

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 Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Adhesions
Arm | Intervention/treatment |
---|---|
Experimental: hyaluronic acid-carboxymethylcellulose treatment group
the HA/CMC treatment group after laparoscopic pelvic surgery
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Drug: hyaluronic acid-carboxymethylcellulose |
No Intervention: control group
the HA/CMC non-treatment group after laparoscopic pelvic surgery
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Primary Outcome Measures :
- 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.
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Tissue Adhesions Cicatrix Fibrosis Pathologic Processes Carboxymethylcellulose Sodium Hyaluronic Acid Adjuvants, Immunologic |
Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents Laxatives Gastrointestinal Agents |