Diverticular Disease of ColonNCT05893095
Evaluation of Laparoscopic Peritoneal Lavage for Perforated Diverticulitis: A National Registry - Based Study
An observational study of Diverticular Disease of Colon and Diverticulitis, Colonic, run by Uppsala University Hospital.
Trial summary
The goal of this observational study is to study the emergency surgical treatment of diverticular disease in Sweden outside clinical trials. The main questions it aims to answer are: Which is the preferred surgical method of acute diverticular disease in Sweden? Which are the short and long-term outcomes of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease of Colon, Diverticulitis, Colonic, Peritonitis
- How many people
- 52,863 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 31 Dec 2020
- 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
- Adult, Older adult
Study population: The study will be based on a national cohort gathered from National Patient Register, the National Cancer Register and the Cause of Death Register, obtained by the Swedish National Board of Health and Welfare.
Who may be able to join
- All patients aged 18 years or older who were admitted to a Swedish hospital between 1st July 2014 and 31st December 2020 with an ICD-10 code for diverticular disease of the large intestine (K57.2- K57.9).
- Emergency admissions.
- Patients who underwent procedures relevant to diverticulitis.
Who cannot join
- Patients who were diagnosed with colorectal cancer before the index date.
- Patients with synchronous operations that are supposed to be irrelevant to acute diverticulitis.
About this study
The goal of this observational study is to study the emergency surgical treatment of diverticular disease in Sweden outside clinical trials. The main questions it aims to answer are:
- Which is the preferred surgical method of acute diverticular disease in Sweden?
- Which are the short and long-term outcomes of the different surgical methods?
Researchers will compare the different methods to see if there is a surgical operation that is superior for the treatment of acute diverticulitis.
Read the detailed description
A retrospective study of patients who were admitted to a Swedish hospital between 1st July 2014 and 31st December 2020 with an ICD-10 code for diverticular disease of the large intestine (K57.2- K57.9) will be included. Patients who underwent procedures relevant to diverticulitis will be identified and therefore will be included. Procedures will be grouped into two categories: Laparoscopic peritoneal lavage (Group I), and sigmoid resection with or without stoma (Group II).
The cohort will be studied from 1st January 1997 until the index date aiming to assess comorbidities, previous abdominal surgeries, and admissions for diverticular disease. A Charlson Comorbidity Index (CCI) system adjusted for Swedish ICD-10 version will be used to calculate a composite score to reflect comorbidity.
- Conditions
- Diverticular Disease of Colon, Diverticulitis, Colonic, Peritonitis, Gastrointestinal Diseases, Digestive System Disease
- Keywords
- Perforated diverticulitis, Purulent peritonitis, Laparoscopic peritoneal lavage
- Medical subject headings
- Diverticulosis, Colonic, Diverticulitis, Colonic, Peritonitis, Gastrointestinal Diseases, Digestive System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferred operation for acute colonic diverticular disease
Laparoscopic peritoneal lavage or sigmoid resection
Measured: Up to 78 months
Secondary outcomes (6)
Crossover surgery
Crossover from laparoscopy to resection surgery
Measured: 1 day
Reoperation
Disease- associated reoperations involving the bowel or abdominal wall
Measured: From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months
Overall survival
Measured: From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months
Postoperative length of hospital stay
Measured: From date of inclusion until the date of discharge, assessed up to 78 months
Colorectal cancer diagnosis
Measured: From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months
Thirty-day postoperative mortality
Measured: Up 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jul 2014
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular Disease of ColonStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 52,863 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Christos Kollatos, Uppsala University Hospital
- Investigators
- Christos Kollatos, MD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893095
- Sponsor's protocol ID
- 2021-01441
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laparoscopic Peritoneal Lavage for Perforated Diverticulitis: A National Registry - Based Study
- ClinicalTrials.gov ID
- NCT05893095
- Acronym / sponsor ID
- 2021-01441
- Conditions
- Diverticular Disease of Colon, Diverticulitis, Colonic, Peritonitis, Gastrointestinal Diseases, Digestive System Disease
- Keywords
- Perforated diverticulitis, Purulent peritonitis, Laparoscopic peritoneal lavage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52,863 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 1 Jul 2014
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jun 2023 (actual)
- 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 goal of this observational study is to study the emergency surgical treatment of diverticular disease in Sweden outside clinical trials. The main questions it aims to answer are:
- Which is the preferred surgical method of acute diverticular disease in Sweden?
- Which are the short and long-term outcomes of the different surgical methods?
Researchers will compare the different methods to see if there is a surgical operation that is superior for the treatment of acute diverticulitis.
Detailed description
A retrospective study of patients who were admitted to a Swedish hospital between 1st July 2014 and 31st December 2020 with an ICD-10 code for diverticular disease of the large intestine (K57.2- K57.9) will be included. Patients who underwent procedures relevant to diverticulitis will be identified and therefore will be included. Procedures will be grouped into two categories: Laparoscopic peritoneal lavage (Group I), and sigmoid resection with or without stoma (Group II).
The cohort will be studied from 1st January 1997 until the index date aiming to assess comorbidities, previous abdominal surgeries, and admissions for diverticular disease. A Charlson Comorbidity Index (CCI) system adjusted for Swedish ICD-10 version will be used to calculate a composite score to reflect comorbidity.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will be based on a national cohort gathered from National Patient Register, the National Cancer Register and the Cause of Death Register, obtained by the Swedish National Board of Health and Welfare.
Key inclusion criteria (3 listed)
- All patients aged 18 years or older who were admitted to a Swedish hospital between 1st July 2014 and 31st December 2020 with an ICD-10 code for diverticular disease of the large intestine (K57.2- K57.9).
- Emergency admissions.
- Patients who underwent procedures relevant to diverticulitis.
Key exclusion criteria (2 listed)
- Patients who were diagnosed with colorectal cancer before the index date.
- Patients with synchronous operations that are supposed to be irrelevant to acute diverticulitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preferred operation for acute colonic diverticular disease
Time frame: Up to 78 months
Laparoscopic peritoneal lavage or sigmoid resection
6 secondary outcomes
Crossover surgery
Time frame: 1 day
Reoperation
Time frame: From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months
Overall survival
Time frame: From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months
Postoperative length of hospital stay
Time frame: From date of inclusion until the date of discharge, assessed up to 78 months
Colorectal cancer diagnosis
Time frame: From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months
Thirty-day postoperative mortality
Time frame: Up 30 days
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 7 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Christos Kollatos, MD principal investigator
Uppsala University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Disease of Colon and Diverticulitis, Colonic, run by Uppsala University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Preferred operation for acute colonic diverticular disease (time frame: Up to 78 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 7 Jun 2023.