To Assess the Anti-adhesive Effect and Safety of Protescal
This multicenter, randomized, single-blind study assessed the safety and efficacy of Protescal for the reduction of post-operative adhesion formation following myomectomy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery|
- presence/absence of postoperative adhesions at second-look procedure [ Time Frame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Protescal is applied to this arm.
|No Intervention: non-treatment|
The age of the patients participating in the study overed 20 years and included nonpregnant women requiring laparoscopic myomectomy and expected to undergo a second-look laparoscopy as part of their treatment plan 5 weeks after the initial surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810900
|Korea, Republic of|
|Hanyang University Hospital||Recruiting|
|Seoul, Korea, Republic of, 133-791|
|Contact: Joongsub Choi, M.D., Ph.D. +82-2290-8416 firstname.lastname@example.org|
|Principal Investigator: Joongsub Choi, M.D., Ph.D.|