EPHAS
Evaluation of Microporous Polysaccharide Hemospheres (MPH) Agent in Preventing Postoperative Complications After Rectal Surgery (EPHAS Study).
Sponsor study identifier
observational
130
1 country
5
Study Start
April 1, 2021
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Study Completion
June 30, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2021
Actual (reported)March 16, 2021
Actual (reported)April 1, 2021
Actual (reported)December 31, 2023
Actual (reported)June 30, 2024
Actual (reported)postoperative pelvic sepsis including anastomotic leakage, pelvic abscess and peritonitis.
% patients with organ-space infection or anastomotic leak
60 days
postoperative morbidities
60 days
rate of reoperation
60 days
Hospital stay
60 days
Use of microporous polysaccharide hemospheres (MPH) agent in patients after rectal surgery to avoid pelvic collections and the use of any drain
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adult patients (aged \>18 years) with a diagnosis of malignant rectal cancer who are scheduled for radical surgery. This study will be conducted in 12 Spanish general hospitals, which are selected on the basis of having established an enhanced recovery protocol that complies with the recommendations of the Aragon Health Sciences Institute (IACS) and Spanish National Health Service (https://portal.guiasalud.es/wpcontent/uploads/2019/10/viaclinica-rica\_english.pdf)
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital de la RIBERA
Alzira, Valencia, Spain
Hospital Jimenz diaz
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Ruiz-Tovar J, Sanchez-Santos R, Martin-Garcia-Almenta E, Garcia Villabona E, Hernandez AM, Hernandez-Matias A, Ramirez JM; grupo de Trabajo de Cirugia Bariatrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after bariatric surgery. Cir Esp (Engl Ed). 2019 Dec;97(10):551-559. doi: 10.1016/j.ciresp.2019.05.003. Epub 2019 Jun 18. English, Spanish.
Ripolles-Melchor J, Ramirez-Rodriguez JM, Casans-Frances R, Aldecoa C, Abad-Motos A, Logrono-Egea M, Garcia-Erce JA, Camps-Cervantes A, Ferrando-Ortola C, Suarez de la Rica A, Cuellar-Martinez A, Marmana-Mezquita S, Abad-Gurumeta A, Calvo-Vecino JM; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (REDGERM). Association Between Use of Enhanced Recovery After Surgery Protocol and Postoperative Complications in Colorectal Surgery: The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study. JAMA Surg. 2019 Aug 1;154(8):725-736. doi: 10.1001/jamasurg.2019.0995.
Javier Blanco, PhD
Hospital de la Ribera
130 participants (actual enrollment reported by the registry).
First Submitted
February 26, 2021
First Posted
March 16, 2021
Study Start
April 1, 2021
Actual (reported)Contact the study team to confirm eligibility.
Cavaliere D, Popivanov G, Cassini D, Cirocchi R, Henry BM, Vettoretto N, Ercolani G, Solaini L, Gerardi C, Tabakov M, Tomaszewski KA. Is a drain necessary after anterior resection of the rectum? A systematic review and meta-analysis. Int J Colorectal Dis. 2019 Jun;34(6):973-981. doi: 10.1007/s00384-019-03276-4. Epub 2019 Apr 25.
Luong J, Milanese E, Fortino J, Vetto JT. Reduction of lymphocele rate in patients undergoing sentinel node biopsy for melanoma by intraoperative placement of plant-based hemostatic powder: Results of a prospective trial. Am J Surg. 2019 May;217(5):878-881. doi: 10.1016/j.amjsurg.2019.02.016. Epub 2019 Feb 14.
Grupo de trabajo. Vía Clínica de Recuperación Intensificada en Cirugía Abdominal (RICA). Vía clínica de recuperación intensificada en cirugía abdominal (RICA) Ministerio de Sanidad, Servicios Sociales e Igualdad. Instituto Aragonés de Ciencias de la Salud. 2014 Available from: http://portal.guiasalud.es/contenidos/iframes/documentos/ opbe/2015-07/ViaClinica-RICA.pdf
Primary Completion
December 31, 2023
Actual (reported)Study Completion
June 30, 2024
Actual (reported)Last Updated
July 16, 2024
Record last verified: 2024-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: