Evidence map›Paper›PMID 32975061›Full record

Trial reportYonsei medical journal2020

A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial.

Dong Yun Lee, Sa Ra Lee, Seul Ki Kim, Jong Kil Joo, Woo Shun Lee, Jung Ho Shin, SiHyun Cho, Joon Cheol Park, Sung Hoon Kim

Registry-linked trialOpen access · goldAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in Yonsei medical journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04007211 (A Randomized, Multi-center, Evaluator and Subject Blind, Active-controlled, Parallel, Medical Device Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Compared to Hyalobarrier Applied to Postoperative Intrauterine), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.9field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04007211 nacompletednot on this map

A Randomized, Multi-center, Evaluator and Subject Blind, Active-controlled, Parallel, Medical Device Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Compared to Hyalobarrier Applied to Postoperative Intrauterine

TypeinterventionalSponsorMedy-ToxRan2017 to 2018Enrolled192ConditionsPostoperative Adhesion of UterusArmsABT13107, Hyalobarrier
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 3 countries.

Dong Yun Lee *Department of Obstetrics & Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-7540-0522
Sa Ra Lee *Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-7890-8348
Seul Ki KimDepartment of Obstetrics & Gynecology, Seoul National University Bundang Hospital, Seongnam, Korea.ORCID https://orcid.org/0000-0002-1647-6711
Jong Kil JooDepartment of Obstetrics & Gynecology, Pusan National University School of Medicine, Busan, Korea.ORCID https://orcid.org/0000-0002-6338-1512
Woo Shun LeeDepartment of Dermatology, Medytox Inc., Seoul, Korea.ORCID https://orcid.org/0000-0003-0385-1495
Jung Ho ShinDepartment of Obstetrics & Gynecology, Guro Hospital, College of Medicine, Korea University, Seoul, Korea.ORCID https://orcid.org/0000-0001-7559-5457
SiHyun ChoDepartment of Obstetrics & Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-2718-6645
Joon Cheol ParkDepartment of Obstetrics & Gynecology, Keimyung University School of Medicine, Daegu, Korea. jcpark@dsmc.or.kr.ORCID https://orcid.org/0000-0002-4103-5969
Sung Hoon KimDepartment of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. kimsung@amc.seoul.kr.ORCID https://orcid.org/0000-0003-2567-2092
Seoul National University Bundang Hospital · KRGangnam Severance Hospital · KRIncyte (United States) · USKeimyung University · KRKorea University Medical Center · KRPusan National University · KRSamsung Medical Center · KRUniversity of Ulsan · KR

Funding

Korea Health Industry Development Institute HI17C0565Medytox Inc.
6 · The paper itself

Abstract

purposeTo investigate the efficacy and safety of a newly developed thermo-responsive sol-gel, ABT13107, for reducing the formation of intrauterine adhesions (IUAs) after hysteroscopic surgery. MATERIALS AND

methodsIn this multicenter, prospective, randomized trial (Canadian Task Force classification I), 192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea were randomized into the ABT13107 group or the comparator (Hyalobarrier®) group in a 1:1 ratio. During hysteroscopic surgery, ABT13107 or Hyalobarrier® was injected to sufficiently cover the entire intrauterine cavity.

resultsThe patients returned to their respective sites for safety assessments at postoperative weeks 1 and 4 and for efficacy assessments at postoperative week 4. The post-surgery incidence of IUAs was 23.4% in the ABT13107 group and 25.8% in the comparator group; this difference met the criteria for ABT13107 to be considered as not inferior to the comparator. No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups. Most adverse events were mild in severity, and no serious adverse events occurred.

conclusionABT13107, a new anti-adhesive barrier containing hyaluronic acid, was not inferior to the highly viscous hyaluronic acid anti-adhesive barrier, Hyalurobarrier® in IUA formation after hysteroscopic surgery (Clinical trial registration No. NCT04007211).

Indexed as

AdultFemaleGelsHumansHyaluronic AcidHysteroscopyIncidencePostoperative ComplicationsPregnancyProspective StudiesRepublic of KoreaSeverity of Illness IndexTissue AdhesionsTreatment OutcomeUterine DiseasesGelsHyaluronic Acidhyaluronic acidHysteroscopyinfertilitytissue adhesionsuterus

Identifiers

PMID32975061
PMCPMC7515784
OpenAlexW3089004718

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.