Postoperative Sepsis Clinical Trial
— EPHASOfficial title:
Evaluation of Microporous Polysaccharide Hemospheres (MPH) Agent in Preventing Postoperative Complications After Rectal Surgery (EPHAS Study).
NCT number | NCT04799379 |
Other study ID # | GERM-EPHAS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | June 30, 2023 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All adult patients (aged >18 years) with a diagnosis of malignant rectal cancer who are scheduled for radical surgery (anterior resection). Informed consent will be obtained from all subjects, who will participate in the study voluntarily. Exclusion Criteria: - Patient refusal, patients undergoing emergency surgery, patients under 18 years of age, existence of other concomitant surgical processes. Previous chemo-radiotherapy. Ileostomy or colostomy. Patients that have receive a drain. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la RIBERA | Alzira | Valencia |
Spain | Hospital General Universitario de Elche | Elche | Alicante |
Spain | Hospital Jimenz diaz | Madrid | |
Spain | Hospital Universitario Infanta Leonor | Madrid | |
Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Grupo Español de Rehabilitación Multimodal | Aragon Health Science Institute, Universidad de Zaragoza |
Spain,
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. — View Citation
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
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. — View Citation
Ripollés-Melchor J, Ramírez-Rodríguez JM, Casans-Francés R, Aldecoa C, Abad-Motos A, Logroño-Egea M, García-Erce JA, Camps-Cervantes Á, Ferrando-Ortolá C, Suarez de la Rica A, Cuellar-Martínez A, Marmaña-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. — View Citation
Ruiz-Tovar J, Sanchez-Santos R, Martín-García-Almenta E, García Villabona E, Hernandez AM, Hernández-Matías A, Ramírez JM; grupo de Trabajo de Cirugía Bariátrica del Grupo Español de Rehabilitación 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative pelvic sepsis including anastomotic leakage, pelvic abscess and peritonitis. | % patients with organ-space infection or anastomotic leak | 60 days | |
Secondary | postoperative morbidities | % Patients with at least one complication related to the surgical intervention | 60 days | |
Secondary | rate of reoperation | % patients requiring reoperation for any cause | 60 days | |
Secondary | Hospital stay | Total number of days of stay included pre and postoperative. | 60 days |