Diverticulitis ColonNCT05393609
Quality of Life and Surgery in Diverticular Disease
An observational study of Diverticulitis Colon and Quality of Life, run by University of Aarhus at 1 site in Denmark.
Trial summary
Diverticular disease is one of the most common diseases of the gastrointestinal tract in industrial countries. Prevalence and admission rate due to diverticular disease increases. Symptomatic patients usually present with acute uncomplicated or complicated diverticulitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis Colon, Quality of Life, Diverticular Disease of Left Side of Colon
- What is being tested?
- Sigmoidectomy and Conservative
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Apr 2022to Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients with recurrent or chronic diverticular disease referred to a surgical department in Central or Northern Denmark Region.
Who may be able to join
- Referred to surgical clinic due to diverticular disease
- Colonic diverticula verified by CT or endoscopy
Who cannot join
- Previous colonic resection other than appendectomy
- Previous or current colorectal cancer
- Previous or current disseminated cancer
- Inflammatory bowel disease
- Psychiatric disorder influencing the ability to answer questionnaires
- Inadequate Danish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katrine J Emmertsen, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Randers Regional Hospital
Randers, Central Jutland, 8930
Helene R Dalby, MD, +4526353245, helecl@rm.dk
About this study
Diverticular disease is one of the most common diseases of the gastrointestinal tract in industrial countries. Prevalence and admission rate due to diverticular disease increases.
Symptomatic patients usually present with acute uncomplicated or complicated diverticulitis. Recurrence rates of complicated diverticulitis are estimated to 10-30%. Recurrences, chronic complications or persisting pain, here collectively referred to as chronic diverticular disease, may be treated by elective sigmoidectomy. Currently, there is no specific criteria for elective surgery, but only a recommendation of a tailored approach depending on the patient's symptoms.
Read more
It is well established that diverticular disease has a negative impact on quality of life (QoL). Elective laparoscopic sigmoidectomy may increase QoL.
In this prospective study, we will prospectively examine QoL, patient-related outcomes and peri- and postoperative outcome of elective sigmoidectomy for chronic diverticular disease, and compare it to conservatively treated patients.
Read the detailed description
Design: Prospective, multicentre, observational
Locations: Hospitals in Central and Northern Denmark Region (6 hospitals).
Time: Recruitment starts in April 2022 and is planned to be completed in 2024.
Patients: All patients referred to a surgical clinic due to chronic diverticular disease.
Allocation for surgery or conservative treatment: Patients will be treated according to Danish National Guidelines for treatment of diverticular disease. The study will not influence the treatment of the patient, but only observe and evaluate current daily practice.
Intervention: Patients will be asked to answer questionnaires at inclusion and again after 1 year. Patients treated with sigmoidectomy will also be asked to answers questionnaires 3 weeks and 3 months after surgery.
- Being tested
- Sigmoidectomy, Conservative
- Medical subject headings
- Diverticulitis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SigmoidectomyProcedure or surgery
Conventional laparoscopic resection of the sigmoid colon
ConservativeDietary supplement
According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.
| Study group | Role | What they receive |
|---|---|---|
| Sigmoidectomy | Patients with diverticular disease undergoing elective resection of the sigmoid colon Receives: Procedure: Sigmoidectomy | |
| Conservative | Patients with diverticular disease not referred to surgery, but conservative treatment Receives: Dietary Supplement: Conservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Gastrointestinal Quality of Life (GIQLI) 36 items. Total score 0-144 (0=worst, 144=best).
Measured: Change from baseline to 1 year follow-up.
Disease-specific quality of life
Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).
Measured: Baseline.
Secondary outcomes (10)
Generic quality of life
EuroQol-5 Domain 5-level (EQ-5D-5L) 5 items. Total score 5-25 (5=best. 25 = worst). Visual analog scale 0-100 (0=worst, 100= best).
Measured: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Bowel function
Patient-assessment of constipation symptoms (PAC-SYM) 12 items. Total score 0-50 (0=best, 50=worst).
Measured: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Bowel function
Low anterior resection syndrome score (LARS score) 5 items. Total score 0-42 (0=best, 42=worst).
Measured: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Pain related to diverticular disease
Modified Rectal Cancer Pain Score 7 items. Total score 0-45 (0= best, 45= worst). 7 item. Total score 0-29 (0= worst, 65= best).
Measured: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Urinary dysfunction - females
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (CIQ-FLUTS) 13 items. Total score 0-52 (0=best, 52=worst).
Measured: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Urinary dysfunction - males
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) 14 items. Total score 0-56 (0=best, 56=worst).
Measured: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Sexual dysfunction - females
Modified Rectal Cancer Female Sexuality Score 7 items. Total score 0-29 (0=best, 29= worst). 14 item. Total score 0-56 (0=best, 56=worst).
Measured: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Sexual dysfunction - males
The International Index of Erectile Function Questionnaire (IIEF) 15 items. Total score 0-65 (0= worst, 65= best).
Measured: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Postoperative morbidity
Postoperative complications classified according to the Clavien-Dindo classification
Measured: 30 days
Postoperative mortality
Mortality within the postoperative period
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start22 Apr 2022
- Primary completionOct 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticulitis ColonStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital
- Responsible party
- Sponsor
- Investigators
- Helene R Dalby, MD, Principal investigator, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393609
- Sponsor's protocol ID
- Life with diverticular disease
- Status last verified
- May 2026
- First submitted
- 11 May 2022
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Surgery in Diverticular Disease
- ClinicalTrials.gov ID
- NCT05393609
- Acronym / sponsor ID
- Life with diverticular disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Randers Regional Hospital
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 May 2022 (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.
Diverticular disease is one of the most common diseases of the gastrointestinal tract in industrial countries. Prevalence and admission rate due to diverticular disease increases.
Symptomatic patients usually present with acute uncomplicated or complicated diverticulitis. Recurrence rates of complicated diverticulitis are estimated to 10-30%. Recurrences, chronic complications or persisting pain, here collectively referred to as chronic diverticular disease, may be treated by elective sigmoidectomy. Currently, there is no specific criteria for elective surgery, but only a recommendation of a tailored approach depending on the patient's symptoms.
It is well established that diverticular disease has a negative impact on quality of life (QoL). Elective laparoscopic sigmoidectomy may increase QoL.
In this prospective study, we will prospectively examine QoL, patient-related outcomes and peri- and postoperative outcome of elective sigmoidectomy for chronic diverticular disease, and compare it to conservatively treated patients.
Detailed description
Design: Prospective, multicentre, observational
Locations: Hospitals in Central and Northern Denmark Region (6 hospitals).
Time: Recruitment starts in April 2022 and is planned to be completed in 2024.
Patients: All patients referred to a surgical clinic due to chronic diverticular disease.
Allocation for surgery or conservative treatment: Patients will be treated according to Danish National Guidelines for treatment of diverticular disease. The study will not influence the treatment of the patient, but only observe and evaluate current daily practice.
Intervention: Patients will be asked to answer questionnaires at inclusion and again after 1 year. Patients treated with sigmoidectomy will also be asked to answers questionnaires 3 weeks and 3 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigmoidectomy | – | Procedure: SigmoidectomyPatients with diverticular disease undergoing elective resection of the sigmoid colon |
| Conservative | – | Dietary Supplement: ConservativePatients with diverticular disease not referred to surgery, but conservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with recurrent or chronic diverticular disease referred to a surgical department in Central or Northern Denmark Region.
Key inclusion criteria (2 listed)
- Referred to surgical clinic due to diverticular disease
- Colonic diverticula verified by CT or endoscopy
Key exclusion criteria (6 listed)
- Previous colonic resection other than appendectomy
- Previous or current colorectal cancer
- Previous or current disseminated cancer
- Inflammatory bowel disease
- Psychiatric disorder influencing the ability to answer questionnaires
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 |
|---|---|---|
| SigmoidectomyConventional laparoscopic resection of the sigmoid colon | Procedure or surgery | Sigmoidectomy |
| ConservativeAccording to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated. | Dietary supplement | Conservative |
Primary outcome
Health related quality of life
Time frame: Change from baseline to 1 year follow-up.
Gastrointestinal Quality of Life (GIQLI) 36 items. Total score 0-144 (0=worst, 144=best).
Disease-specific quality of life
Time frame: Baseline.
Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).
10 secondary outcomes
Generic quality of life
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Bowel function
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Bowel function
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Pain related to diverticular disease
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Urinary dysfunction - females
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Urinary dysfunction - males
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Sexual dysfunction - females
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Sexual dysfunction - males
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Postoperative morbidity
Time frame: 30 days
Postoperative mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- 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.
Katrine J Emmertsen, MD, PhD contact
Helene R Dalby, MD principal investigator
Randers Regional Hospital
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 Colon and Quality of Life, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helene R Dalby, MD (+45 42 65 93 92, helecl@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: Change from baseline to 1 year follow-up.). The study lists 2 primary outcomes in all. 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 12 May 2026.