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NCT04799379: EPHAS

Microporous Polysaccharide Hemospheres (MPH) Improving Outcome After Rectal Surgery

Completed Last updated 16 July 2024
What this trial tests

trial testing microporous polysaccharide hemospheres (MPH) agent in rectal surgery in Postoperative Sepsis in 130 participants. Completed in 30 June 2024.

Timeline
1 April 2021
Primary endpoint
31 December 2023
30 June 2024

Quick facts

Lead sponsorGrupo Español de Rehabilitación Multimodal
StatusCompleted
Study typeOBSERVATIONAL
Enrollment130
Start date1 April 2021
Primary completion31 December 2023
Estimated completion30 June 2024
Sites5 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Grupo Español de Rehabilitación Multimodal — full company profile →

Who can join

18 and older, any sex, with Postoperative Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multi-center, prospective, cohort study, of patients scheduled for elective rectal surgery who received absorbable hemostatic powder to assess whether it can improve patient postoperative outcomes, reduce usage of drains and prove to be cost-effective. This cohort will be compared to a previously studied cohort using drains (Power and IMPRICA study) with comparable patient characteristics. The primary endpoint of the study is: postoperative pelvic sepsis within 60 postoperative days including anastomotic leakage, pelvic abscess and peritonitis. Secondary endpoints: postoperative morbidities, rate of reoperation and length of hospitalization.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Propensity score-matched analysis comparing drains and no-drains in rectal cancer surgery: the value of using a hemostatic agent instead - a prospective observational study.
    Blanco FJ, Castillo J, Mariner S, Reig M, et al · · 2025 · cited 2× · PMID 40638367 · DOI 10.1097/js9.0000000000002965

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Other Grupo Español de Rehabilitación Multimodal trials

Trials by the same sponsor.

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Data sources for this page

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