Diverticulitis of SigmoidDATENCT05942833
Quality of Life in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
A study testing Sigmoid resection in people with Diverticulitis of Sigmoid, run by Kepler University Hospital at 4 sites in 2 countries.
Trial summary
Patients presenting in hospital with symptoms of acute diverticulitis. Acute inflammation of the left-sided colon is confirmed with CT scan or ultrasound in experienced centers and diagnosis is defined according to the "Classification of Diverticular Disease (CDD)". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis of Sigmoid
- What is being tested?
- Sigmoid resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Jan 2023to Jul 2027
- Phase
- Interventional
- 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
Who may be able to join
- Informed consent to participate in the study
- CDD Type 2a, 2b: acute complicated left-sided diverticulitis
- CDD Type 3b: relapsing diverticulitis without complications (>2 episodes within 2 years)
- Acute presentation
- Inflammation located in the left-sided colon
- Inflammation is CT proven or ultrasound confirmed from experienced radiologists
Who cannot join
- < 18 years
- Pregnancy
- BMI > 55kg/m2
- Current colorectal carcinoma in the left-sided colon
- Oral and/or intravenous corticosteroid
- Ongoing chemotherapy
Show all 9Show fewer
- Status post left hemicolectomy
- Patients who cannot take care of themselves at home or are unable to follow instructions
- Patients who are not fit for surgery (anesthesia, expert knowledge from specialists) and will not benefit from surgery
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Austria3 sites, 3 recruiting
- Recruiting
Ordensklinikum Elisabethinen Linz
Linz, Austria, 4020
Matthias Biebl, Dr., +43 (0)732-7677 - 7300, matthias.biebl@ordensklinikum.at
Christoph Schwaiger-Hengstschläger, Dr., +43 (0)732-7677 - 7300
- Recruiting
Krankenhaus Barmherzige Schwestern Linz
Linz, Upper Austria, 4010
Matthias Biebl, Dr., +43 (0)732-7677 - 7300, matthias.biebl@ordensklinikum.at
Gerd Pressl, Dr., +43 732 7677 - 7300, gerd.pressl@ordensklinikum.at
- Recruiting
Kepler University Hospital
Linz, Upper Austria, 4020
Sandra Raab, Dr., +43 (0)5 7680 83 - 78470, sandra.raab@kepleruniklinikum.at
Andreas Shamiyeh, Dr., +43 (0)5 7680 83 - 2133, andreas.shamiyeh@kepleruniklinikum.at
Germany1 site, 1 recruiting
- Not yet recruiting
Universitätsklinikum Mannheim
Mannheim, Mannheim, 68167
Steffen Seyfried, PD MD, +49 621 383-4864, steffen.seyfried@umm.de
Christoph Reißfelder, Prof. MD, +49 621 383-4864, christoph.reißfelder@umm.de
About this study
Official title: DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
Patients presenting in hospital with symptoms of acute diverticulitis. Acute inflammation of the left-sided colon is confirmed with CT scan or ultrasound in experienced centers and diagnosis is defined according to the "Classification of Diverticular Disease (CDD)". CDD Type 2a, 2b and 3b will be included and then randomized in two groups. Group A will get an early left hemicolectomy 7 to 10 days after admission and initial antibiotic therapy and/or drainage of the abscess. Group B is designated for an elective resection 6 to 8 weeks after dismissal at the earliest and initial conservative treatment and/or after drainage of the abscess. Six weeks after the operation patients of Group A will be asked for their present quality of life with a standardized scoring system (Gastrointestinal Quality of Life Index = GIQLI; Short-form 36 Score = SF-36 Score; Low anterior resection syndrome = LARS Score). Group B (elective resection) will be asked at their readmission prior to elective surgery is done. This survey package will be repeated again 6 to 8 weeks later in both groups. Primary endpoints will be the two GIQLI at the said examination times. Secondary endpoints will be SF-36 score, LARS-score, GIQLI-Domains, anastomosis insufficiency and other complications, mortality and length of hospital stay. Comparisons between the groups are made at the said examination times but also 6-8 weeks after the operation.
Read the detailed description
Primary endpoints:
Gastrointestinal Quality of Life Index (GIQLI)
Secondary endpoints:
SF-36 score (physical and mental health summary scores), LARS score, GIQLI-domains, anastomosis insufficiency and other complications, exitus and length of hospital stay
Treatment strategy:
A patient is coming into the hospital with acute symptoms of diverticulitis. The diagnosis must then be confirmed either with ultrasound or with a CT scan. After confirmation the patient is asked to be part of the study. At that point of time the patient does not know his randomization. After the patient's approval and signed consent the patients will bei informed about the further procedure and the appointment of surgery. Questionnaires will now be filled out and antibiotical treatment starts. If necessary a radiological intervention (drainage) is performed.
Is the patient is randomized into Group A he will get early left hemicolectomy immediately up to a maximum of 2 days after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage). If the patient is in Group B he will receive an elective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage).
Reassessment of the questionnaires will bei done in both groups. Group A will be asked 6-8 after surgery and again 6-8 weeks after the second reassessment.
Group B will be asked 6-8 weeks after discharge (directly before surgery) and again 6-8 weeks after surgery.
The aim of the study is to evaluate the outcome and quality of life in patients receiving early surgery versus elective resection of the left-sided colon in acute complicated diverticulitis and chronic recurrent diverticulitis with acute exacerbation.
- Conditions
- Diverticulitis of Sigmoid
- Being tested
- Sigmoid resection
- Keywords
- Recurrent diverticulitis, Quality of life, Acute complicated Diverticulitis, Early resection, Elective resection
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigmoid resectionProcedure or surgery
Timing of sigmoid resection
| Study group | Role | What they receive |
|---|---|---|
| Group A (Early) | Experimental | Early left hemicolectomy immediately up to a maximum of 2 days after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis Receives: Procedure: Sigmoid resection |
| Group B (Late) | Other | Elective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis Receives: Procedure: Sigmoid resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Quality of Life Index
Quality of Life
Measured: Up to 18 weeks
Secondary outcomes (8)
SF-36 score (Short form score)
physical and mental health summary scores (0-100), the higher the better
Measured: Up to 18 weeks
Low anterior resection syndrome score
points (0-40), the lower the better
Measured: Up to 18 weeks
Anastomosis insufficiency
yes/no
Measured: Up to 18 weeks
Intraoperative complication
bleeding, ureter harming (yes/no)
Measured: Up to 18 weeks
Exitus
yes/no
Measured: Up to 18 weeks
Length of stay (sum of days in hospital until end of study)
days
Measured: Up to 18 weeks
Earlier readmission due to recurrence while waiting for surgery
Only in Group B
Measured: Up to 18 weeks
Postoperative complication
pneumonia, urinary tract infection (yes/no)
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start16 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticulitis of SigmoidStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized controlled
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital, Universitätsmedizin Mannheim
- Responsible party
- Sponsor
- Investigators
- Andreas Shamiyeh, Dr., Principal investigator, Kepler University Hospital Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942833
- Sponsor's protocol ID
- 1203/2022
- Acronym
- DATE
- Status last verified
- Mar 2026
- First submitted
- 7 Jun 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
- ClinicalTrials.gov ID
- NCT05942833
- Acronym / sponsor ID
- DATE / 1203/2022
- Conditions
- Diverticulitis of Sigmoid
- Keywords
- Recurrent diverticulitis, Quality of life, Acute complicated Diverticulitis, Early resection, Elective resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Collaborators
- Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital, Universitätsmedizin Mannheim
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 12 Jul 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.
Patients presenting in hospital with symptoms of acute diverticulitis. Acute inflammation of the left-sided colon is confirmed with CT scan or ultrasound in experienced centers and diagnosis is defined according to the "Classification of Diverticular Disease (CDD)". CDD Type 2a, 2b and 3b will be included and then randomized in two groups. Group A will get an early left hemicolectomy 7 to 10 days after admission and initial antibiotic therapy and/or drainage of the abscess. Group B is designated for an elective resection 6 to 8 weeks after dismissal at the earliest and initial conservative treatment and/or after drainage of the abscess. Six weeks after the operation patients of Group A will be asked for their present quality of life with a standardized scoring system (Gastrointestinal Quality of Life Index = GIQLI; Short-form 36 Score = SF-36 Score; Low anterior resection syndrome = LARS Score). Group B (elective resection) will be asked at their readmission prior to elective surgery is done. This survey package will be repeated again 6 to 8 weeks later in both groups. Primary endpoints will be the two GIQLI at the said examination times. Secondary endpoints will be SF-36 score, LARS-score, GIQLI-Domains, anastomosis insufficiency and other complications, mortality and length of hospital stay. Comparisons between the groups are made at the said examination times but also 6-8 weeks after the operation.
Detailed description
Primary endpoints:
Gastrointestinal Quality of Life Index (GIQLI)
Secondary endpoints:
SF-36 score (physical and mental health summary scores), LARS score, GIQLI-domains, anastomosis insufficiency and other complications, exitus and length of hospital stay
Treatment strategy:
A patient is coming into the hospital with acute symptoms of diverticulitis. The diagnosis must then be confirmed either with ultrasound or with a CT scan. After confirmation the patient is asked to be part of the study. At that point of time the patient does not know his randomization. After the patient's approval and signed consent the patients will bei informed about the further procedure and the appointment of surgery. Questionnaires will now be filled out and antibiotical treatment starts. If necessary a radiological intervention (drainage) is performed.
Is the patient is randomized into Group A he will get early left hemicolectomy immediately up to a maximum of 2 days after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage). If the patient is in Group B he will receive an elective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage).
Reassessment of the questionnaires will bei done in both groups. Group A will be asked 6-8 after surgery and again 6-8 weeks after the second reassessment.
Group B will be asked 6-8 weeks after discharge (directly before surgery) and again 6-8 weeks after surgery.
The aim of the study is to evaluate the outcome and quality of life in patients receiving early surgery versus elective resection of the left-sided colon in acute complicated diverticulitis and chronic recurrent diverticulitis with acute exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Group A (Early) | Experimental | Procedure: Sigmoid resectionEarly left hemicolectomy immediately up to a maximum of 2 days after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis |
| Group B (Late) | Other | Procedure: Sigmoid resectionElective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent to participate in the study
- CDD Type 2a, 2b: acute complicated left-sided diverticulitis
- CDD Type 3b: relapsing diverticulitis without complications (>2 episodes within 2 years)
- Acute presentation
- Inflammation located in the left-sided colon
Key exclusion criteria (9 listed)
- < 18 years
- Pregnancy
- BMI > 55kg/m2
- Current colorectal carcinoma in the left-sided colon
- Oral and/or intravenous corticosteroid
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 |
|---|---|---|
| Sigmoid resectionTiming of sigmoid resection | Procedure or surgery | Group A (Early), Group B (Late) |
Primary outcome
Gastrointestinal Quality of Life Index
Time frame: Up to 18 weeks
Quality of Life
8 secondary outcomes
SF-36 score (Short form score)
Time frame: Up to 18 weeks
Low anterior resection syndrome score
Time frame: Up to 18 weeks
Anastomosis insufficiency
Time frame: Up to 18 weeks
Intraoperative complication
Time frame: Up to 18 weeks
Exitus
Time frame: Up to 18 weeks
Length of stay (sum of days in hospital until end of study)
Time frame: Up to 18 weeks
Earlier readmission due to recurrence while waiting for surgery
Time frame: Up to 18 weeks
Postoperative complication
Time frame: Up to 18 weeks
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 18 Mar 2026.
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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.
Andreas Shamiyeh, Dr. principal investigator
Kepler University Hospital Linz
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sigmoid resection in people with Diverticulitis of Sigmoid, run by Kepler University Hospital at 4 sites in 2 countries.
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 6 inclusion and 9 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Germany. 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 Sandra Raab, Dr. (+43 (0)5 7680 83 - 78470, sandra.raab@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Quality of Life Index (time frame: Up to 18 weeks). 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 18 Mar 2026.