Laparoscopic-lavage Observational Study (LLOS)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

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Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	500 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Target Follow-Up Duration:	5 Years
Official Title:	Laparoscopic-lavage Observational Study
Study Start Date :	June 2016
Estimated Primary Completion Date :	February 2019
Estimated Study Completion Date :	February 2019

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. conversion to any form of laparoscopy [ Time Frame: intraoperative ]
   conversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection)
2. conversion to laparotomy [ Time Frame: intraoperative ]
   conversion to laparotomy (with or without bowel resection)
3. 30 days post-operative mortality [ Time Frame: 30 days ]
4. 30 days post-operative surgical re-interventions rate [ Time Frame: 30 days ]
5. 30 days post-operative percutaneous drainage rate [ Time Frame: 30 days ]
6. hospital readmission rate for recurrence of diverticulitis [ Time Frame: 30 days ]
7. visualisation of colonic perforation [ Time Frame: intraoperative ]
   rate of visualisation of colonic perforation during laparoscopic peritoneal lavage
8. visceral adhesiolysis [ Time Frame: intraoperative ]
   consistency, if any, of visceral adhesiolysis performed during the procedure
9. duration of follow-up [ Time Frame: 12 ]
10. post-lavage elective resection rate (lavage "bridge" to resection) [ Time Frame: 12 months ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Alberto Arezzo, MD		alberto.arezzo@unito.it

Locations

Italy
Gian Andrea Binda	Recruiting
Genova, Italy
Contact: Gian Andrea Binda, MD
Principal Investigator: Gian Andrea Binda, MD
Sub-Investigator: Marco A Bonino, MD

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	January 25, 2016
Last Update Posted:	October 26, 2017
Last Verified:	October 2017
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