DiverticulitisLLOSNCT02662088
Laparoscopic-lavage Observational Study
An observational study of Diverticulitis, run by University of Turin, Italy at 1 site in Italy.
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.
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 group | Role | What they receive |
|---|---|---|
| Laparoscopic-lavage | Patients 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.
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)
conversion to any form of laparoscopy
conversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection)
Measured: intraoperative
conversion to laparotomy
conversion to laparotomy (with or without bowel resection)
Measured: intraoperative
30 days post-operative mortality
Measured: 30 days
30 days post-operative surgical re-interventions rate
Measured: 30 days
30 days post-operative percutaneous drainage rate
Measured: 30 days
hospital readmission rate for recurrence of diverticulitis
Measured: 30 days
visualisation of colonic perforation
rate of visualisation of colonic perforation during laparoscopic peritoneal lavage
Measured: intraoperative
visceral adhesiolysis
consistency, if any, of visceral adhesiolysis performed during the procedure
Measured: intraoperative
duration of follow-up
Measured: 12
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.
- First posted25 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Arezzo, University of Turin, Italy
- Investigators
- Gian Andrea Binda, MD, Principal investigator, Ospedali Galliera, Genova, ItalyRoberto Cirocchi, MD, Principal investigator, University of Perugia - TerniSalomone Di Saverio, MD, Principal investigator, Maggiore Hospital, AUSL Bologna, ItalyNereo Vettoretto, MD, Principal investigator, Ospedale Montichiari, Italy
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic-lavage Observational Study
- ClinicalTrials.gov ID
- NCT02662088
- Acronym / sponsor ID
- LLOS / LLOSTUDY-1
- Conditions
- Diverticulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic-lavage | – | Procedure: laparoscopic-lavagePatients with colonic diverticulitis submitted to laparoscopic lavage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each patient is required to meet all of the inclusion criteria and none of the exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic-lavage | Procedure or surgery | Laparoscopic-lavage |
Primary outcome
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
10 secondary outcomes
conversion to any form of laparoscopy
Time frame: intraoperative
conversion to laparotomy
Time frame: intraoperative
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
visceral adhesiolysis
Time frame: intraoperative
duration of follow-up
Time frame: 12
post-lavage elective resection rate (lavage "bridge" to resection)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gian Andrea Binda, MD principal investigator
Ospedali Galliera, Genova, Italy
Roberto Cirocchi, MD principal investigator
University of Perugia - Terni
Salomone Di Saverio, MD principal investigator
Maggiore Hospital, AUSL Bologna, Italy
1 site in 1 country: see every site and its status.
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.