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Trial record 1 of 1 for:    NCT02662088
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Laparoscopic-lavage Observational Study (LLOS)

This study is currently recruiting participants.
Verified October 2017 by Alberto Arezzo, University of Turin, Italy
Sponsor:
ClinicalTrials.gov Identifier:
NCT02662088
First Posted: January 25, 2016
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alberto Arezzo, University of Turin, Italy
  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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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

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 Submitted: January 20, 2016
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