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Microporous Polysaccharide Hemospheres (MPH) Improving Outcome After Rectal Surgery

NCT04799379 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2024-07-16

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Sepsis

Interventions

DRUG

microporous polysaccharide hemospheres (MPH) agent in rectal surgery

Use of microporous polysaccharide hemospheres (MPH) agent in patients after rectal surgery to avoid pelvic collections and the use of any drain

Sponsors & Collaborators

  • Universidad de Zaragoza

    collaborator OTHER

  • Aragon Health Science Institute

    collaborator OTHER_GOV

  • Grupo Español de Rehabilitación Multimodal

    lead OTHER

Principal Investigators

  • Javier Blanco, PhD · Hospital de la Ribera

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04799379 on ClinicalTrials.gov