Last updated: April 22, 2022
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Active - Recruiting
Phase
4
Condition
N/ATreatment
N/AClinical Study ID
NCT04161599
2019-004283-21
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients of both genders, aged 18 years or above, with colonic disease withoutcontraindications to surgical treatment, diagnosed with neoplasia or diverticulardisease (diverticulosis with indication to elective surgery: stricture, chronicconstipation), patients for whom a segmental or total colectomy is indicated.
- Patients who voluntarily accept to join the study and sign a dedicated writtenconsent.
- Capability of understanding the study and take the medications prescribed.
Exclusion
Exclusion Criteria:
- Patients undergoing urgent surgery or no elective admission
- Patients who refuse to participate
- Patients with rectal disease or neoplasia
- Patients with pre-existing intrabdominal sepsis (abscess, acute diverticulitis)
- Patients who received preoperative antibiotic treatment for any other reasons duringthe two weeks before surgery
- Patients with Crohn's disease or ulcerative colitis
- Patients unlikely to adhere to the treatment prescribed
- Patients with allergy or contraindication to the medications used in the study
- Patients who need mechanical bowel preparation
- Patients with contraindication to bowel preparation used in the study (Citrafleet®):
- Patients with kidney failure needing haemodialysis or with hypermagnesemia
- Patients with severe heart failure
- Patients with gastric or duodenal ulcer
- Patients with mechanical obstruction
- Patients with toxic megacolon
- Patients with ascites or rhabdomyolysis
Study Design
Total Participants: 968
Study Start date:
March 01, 2022
Estimated Completion Date:
July 31, 2024
Study Description
Connect with a study center
Jinling Hospital
Nanjing,
ChinaActive - Recruiting
General University Hospital of Patras
Patra,
GreeceActive - Recruiting
Humanitas Research Hospital
Rozzano,
ItalyActive - Recruiting
Tomsk Oncological Hospital
Tomsk,
Russian FederationActive - Recruiting
Hospital General Universitario Vall d´Hebron
Barcelona, Barcelona, Spain 08035
SpainActive - Recruiting
Hospital de Bellvitge
Barcelona, Hospitalet De Llobregat, Barcelona, Spain 08907
SpainActive - Recruiting
Hospital Universitario Cruces
Cruces,
SpainActive - Recruiting
Hospital Universitario Lucus Augusti
Lugo,
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid,
SpainActive - Recruiting
CHUV Centre Hospitalier Universitaire Vaudois
Losanna,
SwitzerlandSite Not Available
Royal Marsden Hospital, Imperial College of London
London,
United KingdomSite Not Available
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