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Trial record 1 of 1 for:    NCT02662088
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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
Sponsor:
Information provided by (Responsible Party):
Alberto Arezzo, University of Turin, Italy

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 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

Resource links provided by the National Library of Medicine


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



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 ]


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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
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


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


Locations
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Italy
Gian Andrea Binda
Genova, Italy
Sponsors and Collaborators
University of Turin, Italy
Investigators
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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

Additional Information:

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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
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases