Evidence map›Paper›PMID 27844212›Full record

Trial reportArchives of gynecology and obstetrics2017

A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier.

Geoffrey H Trew, George A Pistofidis, Sara Y Brucker, Bernhard Krämer, Nicole M Ziegler, Matthias Korell, Henning Ritter, Alex McConnachie, Ian Ford, Alison M Crowe and 3 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Archives of gynecology and obstetrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Barrier agents for adhesion prevention after gynaecological surgery.The Cochrane database of systematic reviews · 2020
    Pooled it
  6. Review
  7. Review
  8. Review
  9. Adhesions and Anti-Adhesion Systems Highlights.Facts, views & vision in ObGyn · 2019
    Review
  10. Article
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

13 authors.

Geoffrey H TrewConsultant in Reproductive Medicine and Surgery, Hammersmith Hospital, Du Cane Road, London, W12 0HS, UK. g.trew@imperial.ac.uk.
George A PistofidisDepartment of Gynecological Endoscopic Surgery, Lefkos Stavros Hospital, Athens, 115 28, Greece.
Sara Y BruckerDepartment of Gynecology and Obstetrics, University of Tübingen, Tübingen, 72076, Germany.
Bernhard KrämerDepartment of Gynecology and Obstetrics, University of Tübingen, Tübingen, 72076, Germany.
Nicole M ZieglerDepartment of Obstetrics, Gynecology, and Gynecology Oncology, Pius Hospital, Oldenburg, 26121, Germany.
Matthias KorellDepartment of Obstetrics and Gynecology, Johanna Etienne Krankenhaus, Neuss, 41462, Germany.
Henning RitterDepartment of Obstetrics, Gynecology, and Gynecology Oncology, Pius Hospital, Oldenburg, 26121, Germany.
Alex McConnachieRobertson Centre for Biostatistics, University of Glasgow, Glasgow, G12 8QQ, UK.
Ian FordRobertson Centre for Biostatistics, University of Glasgow, Glasgow, G12 8QQ, UK.
Alison M CroweCorvus Communications Ltd, East Sussex, TN22 4PB, UK.ORCID http://orcid.org/0000-0003-2077-1227
Trudy D EstridgeActamax Surgical Materials LLC, Wilmington, DE, 19803, USA.
Michael P DiamondDepartment of Obstetrics and Gynecology, Augusta University, Augusta, GA, 30912, USA.
Rudy L De WildeDepartment of Obstetrics, Gynecology, and Gynecology Oncology, Pius Hospital, Oldenburg, 26121, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePost-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery.

methodsThis first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL.

resultsNo adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34).

conclusionSpray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.

Indexed as

AdultFemaleGynecologic Surgical ProceduresHumansHydrogel, Polyethylene Glycol DimethacrylateLaparoscopyPolyethylene GlycolsPostoperative ComplicationsProspective StudiesTissue AdhesionsUterine MyomectomyHydrogel, Polyethylene Glycol DimethacrylatePolyethylene GlycolsAdhesion barrier studyGynecological laparoscopic surgeryHydrogel adhesion barrierPost-surgical adhesionsSecond-look laparoscopy

Identifiers

PMID27844212
PMCPMC5281664

What OpenQuestion holds

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Registered trials

None linked

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.