Microporous Polysaccharide Hemospheres (MPH) Improving Outcome After Rectal Surgery

NCT04799379 | Completed

• 1 other identifier: GERM-EPHAS
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Rectal surgery; Pelvic drain; microporous polysaccharide hemospheres

Outcome Measures

Primary Outcomes (1)

• postoperative pelvic sepsis including anastomotic leakage, pelvic abscess and peritonitis.

  % patients with organ-space infection or anastomotic leak

  60 days

Secondary Outcomes (3)

• postoperative morbidities

  60 days

• rate of reoperation

  60 days

• Hospital stay

  60 days

Interventions

microporous polysaccharide hemospheres (MPH) agent in rectal surgery DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Español de Rehabilitación Multimodal: lead
• Universidad de Zaragoza: collaborator
• Aragon Health Science Institute: collaborator

Study Sites (5)

Hospital General Universitario de Elche

Elche, Alicante, Spain

Location

Hospital de la RIBERA

Alzira, Valencia, Spain

Location

Hospital Jimenz diaz

Madrid, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Related Publications (5)

• 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.

  PMID: 31221424 BACKGROUND

• 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.

  PMID: 31066889 BACKGROUND

• 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.

  PMID: 31025093 BACKGROUND

• 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.

  PMID: 30799018 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Interventions

5,10-dihydro-5-methylphenazine; Pharmaceutical Preparations

Study Officials

• Javier Blanco, PhD

  Hospital de la Ribera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 16, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

ES (5)