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Trial record 1 of 1 for:
NCT02662088
Laparoscopic-lavage Observational Study (LLOS)
This study is not yet open for participant recruitment.
Verified May 2016 by Alberto Arezzo, University of Turin, Italy
Sponsor:
University of Turin, Italy
Information provided by (Responsible Party):
Alberto Arezzo, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT02662088
First received: January 20, 2016
Last updated: May 4, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Diverticulitis | Procedure: laparoscopic-lavage |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Laparoscopic-lavage Observational Study |
Resource links provided by NLM:
Further study details as provided by Alberto Arezzo, University of Turin, Italy:
Primary Outcome Measures:
- success rate [ 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
Secondary Outcome Measures:
- conversion to any form of laparoscopy [ Time Frame: intraoperative ]conversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection)
- conversion to laparotomy [ Time Frame: intraoperative ]conversion to laparotomy (with or without bowel resection)
- 30 days post-operative mortality [ Time Frame: 30 days ]
- 30 days post-operative surgical re-interventions rate [ Time Frame: 30 days ]
- 30 days post-operative percutaneous drainage rate [ Time Frame: 30 days ]
- hospital readmission rate for recurrence of diverticulitis [ Time Frame: 30 days ]
- visualisation of colonic perforation [ Time Frame: intraoperative ]rate of visualisation of colonic perforation during laparoscopic peritoneal lavage
- visceral adhesiolysis [ Time Frame: intraoperative ]consistency, if any, of visceral adhesiolysis performed during the procedure
- duration of follow-up [ Time Frame: 12 ]
- post-lavage elective resection rate (lavage "bridge" to resection) [ Time Frame: 12 months ]
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2016 |
| Estimated Study Completion Date: | February 2019 |
| Estimated Primary Completion Date: | February 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Laparoscopic-lavage
Patients with colonic diverticulitis submitted to laparoscopic lavage
|
Procedure: laparoscopic-lavage |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Each patient is required to meet all of the inclusion criteria and none of the exclusion criteria
Criteria
Inclusion criteria Patients with colonic diverticulitis submitted to laparoscopic lavage
Exclusion criteria Patients with occasional finding of colo-rectal cancer
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02662088
Please refer to this study by its ClinicalTrials.gov identifier: NCT02662088
Contacts
| Contact: Alberto Arezzo, MD | alberto.arezzo@unito.it |
Sponsors and Collaborators
University of Turin, Italy
Investigators
| Principal Investigator: | Gian Andrea Binda, MD | Ospedali Galliera, Genova, Italy |
| Principal Investigator: | Roberto Cirocchi, MD | University of Perugia - Terni |
| Principal Investigator: | Salomone Di Saverio, MD | Maggiore Hospital, AUSL Bologna, Italy |
| Principal Investigator: | Nereo Vettoretto, MD | Ospedale Montichiari, Italy |
More Information
| Responsible Party: | Alberto Arezzo, Associate Professor of Surgery, University of Turin, Italy |
| ClinicalTrials.gov Identifier: | NCT02662088 History of Changes |
| Other Study ID Numbers: |
LLOSTUDY-1 |
| Study First Received: | January 20, 2016 |
| Last Updated: | May 4, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
Additional relevant MeSH terms:
|
Diverticulitis Intraabdominal Infections Infection |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017