NCT02773251

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 prostate-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.6 years

First QC Date

May 12, 2016

Last Update Submit

May 14, 2016

Conditions

Prostate CancerPostoperative Adhesion

Keywords

Postoperative adhesionLaparoscopyAdhesion barrier

Outcome Measures

Primary Outcomes (1)

  • the difference in excursion distance on viscera slide ultrasound between V0 and V2.

    within the first 6 months after surgery

Study Arms (2)

hyaluronic acid-carboxymethylcellulose treatment group

EXPERIMENTAL

the HA/CMC treatment group after laparoscopic pelvic surgery

Drug: hyaluronic acid-carboxymethylcellulose

control group

NO INTERVENTION

the HA/CMC non-treatment group after laparoscopic pelvic surgery

Interventions

hyaluronic acid-carboxymethylcelluloseDRUG
hyaluronic acid-carboxymethylcellulose treatment group

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ha US, Koh JS, Cho KJ, Yoon BI, Lee KW, Hong SH, Lee JY. Hyaluronic acid-carboxymethylcellulose reduced postoperative bowel adhesions following laparoscopic urologic pelvic surgery: a prospective, randomized, controlled, single-blind study. BMC Urol. 2016 Jun 10;16(1):28. doi: 10.1186/s12894-016-0149-3.

    PMID: 27286961DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 16, 2016

Study Start

November 1, 2011

Primary Completion

June 1, 2014

Last Updated

May 17, 2016

Record last verified: 2016-05