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DiverticulitisLLOSNCT02662088

Laparoscopic-lavage Observational Study

An observational study of Diverticulitis, run by University of Turin, Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diverticulitis
What is being tested?
laparoscopic-lavage
Type of treatment
Surgery or procedure
How many people
404 participants
Where
1 siteItaly
Study dates
Jun 2016to Jan 2018
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Each patient is required to meet all of the inclusion criteria and none of the exclusion criteria

Inclusion criteria Patients with colonic diverticulitis submitted to laparoscopic lavage

Exclusion criteria Patients with occasional finding of colo-rectal cancer

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Gian Andrea Binda

    Genova

Other trials in Italy

About this study

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.
Read the detailed description

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.

This "ad hoc" registry will allow centers to retrospectively fill in the data of their patients; the information will be obtained from existing records, diagnostic tests and surgical intervention descriptions. Data will be collected and recorded by all institutions through a specific online shared system.

To facilitate and standardize data collection through a shared database and to ensure the safety of sensitive data, a special online computerized web system has been developed.

Investigators have to provide the required data as fully as possible; however, the lack of certain data does not preclude from sending the remaining data.

Specific aims

  • Analyze general outcome
  • Analyze the different techniques of laparoscopic lavage
  • Analyze the different inclusion criteria
  • Analyze the different follow-up

Primary outcome for this retrospective observational study is:

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 outcomes are:

  • conversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection)
  • conversion to laparotomy (with or without bowel resection)
  • 30 days post-operative mortality;
  • 30 days post-operative surgical re-interventions rate;
  • 30 days post-operative percutaneous drainage rate;
  • hospital readmission rate for recurrence of diverticulitis;
  • - rate of visualisation of colonic perforation during laparoscopic peritoneal lavage;
  • surgical strategies used in case of detection of a colonic perforation;
  • consistency, if any, of visceral adhesiolysis performed during the procedure;
  • duration of follow-up
  • post-lavage elective resection rate (lavage "bridge" to resection)

Eligibility Each patient is required to meet all of the inclusion criteria and none of the exclusion criteria.

Inclusion criteria Patients with colonic diverticulitis submitted to laparoscopic lavage

Exclusion criteria Patients with occasional finding of colo-rectal cancer

Data collection Patient demographics

  • Year of birth
  • Sex
  • Body Mass Index (BMI)
  • ASA score
  • Haemodynamic condition (stable or unstable)
  • Previous abdominal surgery
  • Previous events of diverticulitis requiring ambulatory investigation or treatment
  • Previous events of diverticulitis requiring hospitalization
  • Abdominal CT scan before surgery (yes/no) and WSES stage (Sartelli M, Moore FA, Ansaloni L, Di Saverio S, Coccolini F, Griffiths EA, et al. A proposal for a CT driven classification of left colon acute diverticulitis. World J Emerg Surg. 2015 World 2015; 10: 3) Surgery
  • Date of Operation
  • Hinchey score (modified Kaiser AM, Jiang JK, Lake JP, Ault G, Artinyan A, Gonzalez-Ruiz C, Essani R, Beart RW Jr. The management of complicated diverticulitis and the role of computed tomography. Am J Gastroenterol 2005; 100: 910-917)
  • Number of trocars inserted
  • Quantity of lavage (cc)
  • Conversion rate to any laparoscopic technique either than lavage
  • Conversion rate to any type of open surgical technique
  • Degree of adhesiolysis performed for searching eventual free colonic perforation (1. none, 2. lysis of weak adhesions, 3. actively searching for any collection with consistent amount of adhesiolysis)
  • Identification of a free colonic perforation during the laparoscopic peritoneal lavage
  • Surgical strategies used in case of detection of a colonic perforation (drainage, stitching, resection)
  • Placement of intra-abdominal drain (number and location)
  • Operative time
  • Estimated blood loss
  • Intraoperative complications
  • Intraoperative death

Postoperative clinical findings

  • Length of postoperative hospital stays
  • Postoperative blood transfusion
  • Liquid diet (POD number)
  • Soft solid diet (POD number)
  • Re-establishment of peristalsis (POD number)
  • First pass of flatus (POD number)
  • Drain removal (POD number)
  • Length and type of intravenous antibiotic use
  • Length of intravenous analgesic use

In-hospital postoperative complications

  • Type of complication
  • Re-operation for complication
  • Dindo-Clavien Grade

Early and late surgery-related complications after discharge

  • Date of hospitalization for diverticulitis recurrence
  • Type of complication
  • Death related to the complication
  • Need of surgery (type of surgery)
  • Need percutaneous drainage
  • Need peritoneal lavage Follow-up
  • Date of last follow-up visit
  • post-Lap lavage elective resection rate (lavage as a "bridge" to resection)
  • Indication to resection (symptoms, prophilaxys of further episodes of acute diverticulitis)
Conditions
Diverticulitis
Being tested
laparoscopic-lavage
Medical subject headings
Diverticulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopic-lavageProcedure or surgery

Study groups in NCT02662088
Study groupRoleWhat they receive
Laparoscopic-lavagePatients with colonic diverticulitis submitted to laparoscopic lavage
Receives: Procedure: laparoscopic-lavage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. success rate

    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

    Measured: 12 months

Secondary outcomes (10)
  1. conversion to any form of laparoscopy

    conversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection)

    Measured: intraoperative

  2. conversion to laparotomy

    conversion to laparotomy (with or without bowel resection)

    Measured: intraoperative

  3. 30 days post-operative mortality

    Measured: 30 days

  4. 30 days post-operative surgical re-interventions rate

    Measured: 30 days

  5. 30 days post-operative percutaneous drainage rate

    Measured: 30 days

  6. hospital readmission rate for recurrence of diverticulitis

    Measured: 30 days

  7. visualisation of colonic perforation

    rate of visualisation of colonic perforation during laparoscopic peritoneal lavage

    Measured: intraoperative

  8. visceral adhesiolysis

    consistency, if any, of visceral adhesiolysis performed during the procedure

    Measured: intraoperative

  9. duration of follow-up

    Measured: 12

  10. post-lavage elective resection rate (lavage "bridge" to resection)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJan 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
404 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02662088
Sponsor's protocol ID
LLOSTUDY-1
Acronym
LLOS
Status last verified
Apr 2019
First submitted
20 Jan 2016
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Diverticulitis, run by University of Turin, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

success rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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