Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04907383 |
| Other study ID # |
233-22042021 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
December 1, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Niguarda Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
A multicenter prospective observational study. Aim of the study is to identify the clinical
parameters correlating with favorable outcomes in patients undergoing surgery or medical
treatment for diverticular disease. The primary aim is be the assessment of quality of life
of theses patients according to the GIQLY score at 1 year from the enrollment in the
registry. Patients will be enrolled in a prospective study and followed for 36 months after
the diagnosis of acute diverticulitis. All participating centres are tertiary hospitals
located in Europe .
Description:
All consecutive patients admitted to a Surgical Unit with a diagnosis of left-side colinic
diverticulitis will be enrolled in the registry. Patients will be identified through their
medical record numbers. One investigator in each center will obtain written informed consent
from each patient and keep the patients updated on data collection.
Inclusion criteria: 1) imaging-proven colonic diverticular disease 2) patient aged > 18 years
old; 3) Written informed consent obtained. 4) A colonoscopy showing diverticular disease will
be required during the follow-up or before surgical treatment if possible Demographic and
functional data will be recorded during the first surgical visit, together with a complete
clinical examination. Data regarding the symptoms of presentation and quality of life will be
collected and categorized. Comorbidity Index adjusted for age will be calculated for every
patient, while those >70 years old will be assessed for frailty risk using the modified
Frailty Index (mFI) described by Robinson et al. Relevant medications will be listed.
Setting, (emergency room vs outpatients clinic), need for admission, treatment, emergency
surgery vs delayed elective surgery vs only medical management (including percutaneous drain
placement) will be recorded.
Intraoperative parameters will be recorded in the registry both for emergency procedures and
elective procedures, including several technical aspects such as level of inferior mesenteric
artery ligtion, type of energy device used, number and type of stapler cartridge, size of
circular stapler,. Use of the laparoscopy technique, conversion rate, peritoneal lavage,
surgical second look will be recorded.
Histopathological examination will be recorded in terms of length of the specimen, the
presence of microscopic or macroscopic abscesses, the presence of Crohn's like reaction or of
lymphocyte infiltration and the eventual presence of unknown cancer.
Post-operative complications will be reported according to the Clavien-Dindo classification
15. Length of stay and post-discharge complications will be evaluated and recorded.
Application of Enhanced recovery protocols will be considered only for at least 80% of the
designed colo-rectal items will be satisfied.
One investigator in each center will be responsible for the follow up data. Functional follow
up will be done yearly according to the GIQLY, FSFI, IIEF, ICIQ, IPSS questionnaires.
Data will be prospectively collected using a REDCAP database by the site principal
investigator for each hospital. Quarterly meetings will be set between the study coordinators
and the participating centers. A data manager (GP) will regularly control the quality of the
data provided
