Laparoscopic-lavage Observational Study (LLOS)
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ClinicalTrials.gov Identifier: NCT02662088 |
Recruitment Status :
Completed
First Posted : January 25, 2016
Last Update Posted : April 17, 2019
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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 or disease | Intervention/treatment |
---|---|
Diverticulitis | Procedure: laparoscopic-lavage |

Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 404 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Target Follow-Up Duration: | 5 Years |
Official Title: | Laparoscopic-lavage Observational Study |
Actual Study Start Date : | June 2016 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | January 2018 |

Group/Cohort | Intervention/treatment |
---|---|
Laparoscopic-lavage
Patients with colonic diverticulitis submitted to laparoscopic lavage
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Procedure: laparoscopic-lavage |
- 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
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion criteria Patients with colonic diverticulitis submitted to laparoscopic lavage
Exclusion criteria Patients with occasional finding of colo-rectal cancer

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662088
Italy | |
Gian Andrea Binda | |
Genova, Italy |
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 |
Responsible Party: | Alberto Arezzo, Associate Professor of Surgery, University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT02662088 |
Other Study ID Numbers: |
LLOSTUDY-1 |
First Posted: | January 25, 2016 Key Record Dates |
Last Update Posted: | April 17, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Diverticulitis Diverticular Diseases Intraabdominal Infections Infection |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |