Gian Andrea Binda
Genova, Italy
NCT Number: NCT02662088
The purpose of this study is to collect a multi-institutional database including all relevant data regarding the surgical and clinical features of patients underwent to laparoscopic lavage for complicated colic diverticulitis. The main objectives are:
* To determine the surgical and clinical outcomes, in the short and long term. * To compare results according to the different type of techniques, device used and manner of execution of the different surgical steps. * To relate results of different surgeries with baseline characteristics of patients and stage of disease.
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Notify Me18 year and older
All sexes
Observational
Genova, Italy
The purpose of this study is to collect a multi-institutional database including all relevant data regarding the surgical and clinical features of patients underwent to laparoscopic lavage for complicated colic diverticulitis. The main objectives are:
This "ad hoc" registry will allow centers to retrospectively fill in the data of their patients; the information will be obtained from existing records, diagnostic tests and surgical intervention descriptions. Data will be collected and recorded by all institutions through a specific online shared system.
To facilitate and standardize data collection through a shared database and to ensure the safety of sensitive data, a special online computerized web system has been developed.
Investigators have to provide the required data as fully as possible; however, the lack of certain data does not preclude from sending the remaining data.
Specific aims
Primary outcome for this retrospective observational study is:
the success rate of laparoscopic peritoneal lavage, defined as the rate of patients alive with no need of further surgical treatment for recurrent attacks of diverticulitis.
Secondary outcomes are:
Eligibility Each patient is required to meet all of the inclusion criteria and none of the exclusion criteria.
Inclusion criteria
Patients with colonic diverticulitis submitted to laparoscopic lavage
Exclusion criteria
Patients with occasional finding of colo-rectal cancer
Data collection Patient demographics
Postoperative clinical findings
In-hospital postoperative complications
Early and late surgery-related complications after discharge
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with colonic diverticulitis submitted to laparoscopic lavage
Exclusion criteria
Patients with occasional finding of colo-rectal cancer
Time frame: 12 months
the success rate of laparoscopic peritoneal lavage, defined as the rate of patients alive with no need of further surgical treatment for recurrent attacks of diverticulitis
Time frame: intraoperative
conversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection)
Time frame: intraoperative
conversion to laparotomy (with or without bowel resection)
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: intraoperative
rate of visualisation of colonic perforation during laparoscopic peritoneal lavage
Time frame: intraoperative
consistency, if any, of visceral adhesiolysis performed during the procedure
Time frame: 12
Time frame: 12 months
University of Turin, Italy
Other
Acronym: LLOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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