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RecruitingNCT05942833DATEUpdated Mar 18, 2026

Quality of Life in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis

An interventional study of Sigmoid resection in Diverticulitis of Sigmoid, sponsored by Kepler University Hospital. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Kepler University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2023, registered Jun 2023).
  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)". 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.

02

Conditions studied

  • Diverticulitis of Sigmoid

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Keywords

  • Recurrent diverticulitis
  • Quality of life
  • Acute complicated Diverticulitis
  • Early resection
  • Elective resection
03

In context

Diverticulitis

125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.

This study's planned enrollment of 136 is above the median of 120 across 63 interventional studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Kepler University Hospital is the lead sponsor of 32 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • \< 18 years
  • Pregnancy
  • > 55kg/m2
  • Current colorectal carcinoma in the left-sided colon
  • Oral and/or intravenous
  • Ongoing chemotherapy
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    Group A (Early)

    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

    Procedure: Sigmoid resection

  • Other
    Group B (Late)

    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

    Procedure: Sigmoid resection

Interventions

  • ProcedureSigmoid resection

    Timing of sigmoid resection

06

What researchers measure

Primary outcomes

  1. Gastrointestinal Quality of Life Index

    Quality of Life

    Time frame: Up to 18 weeks

Secondary outcomes

  1. SF-36 score (Short form score)

    physical and mental health summary scores (0-100), the higher the better

    Time frame: Up to 18 weeks

  2. Low anterior resection syndrome score

    points (0-40), the lower the better

    Time frame: Up to 18 weeks

  3. Anastomosis insufficiency

    yes/no

    Time frame: Up to 18 weeks

  4. Intraoperative complication

    bleeding, ureter harming (yes/no)

    Time frame: Up to 18 weeks

  5. Exitus

    yes/no

    Time frame: Up to 18 weeks

  6. Length of stay (sum of days in hospital until end of study)

    days

    Time frame: Up to 18 weeks

  7. Earlier readmission due to recurrence while waiting for surgery

    Only in Group B

    Time frame: Up to 18 weeks

  8. Postoperative complication

    pneumonia, urinary tract infection (yes/no)

    Time frame: Up to 18 weeks

07

Study locations

3 of 4 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Dec 2026, 47 months after the start.

Of 16 interventional studies with no phase under Diverticulitis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's planned 47 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2023
First posted
Jul 12, 2023
StartActual
Jan 16, 2023
Primary completionEst.
Dec 2026
CompletionEst.
Jul 2027
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05942833
Lead sponsor
Kepler University Hospital
Collaborators
Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital, Universitätsmedizin Mannheim
Responsible party
Sponsor
First posted
Jul 12, 2023
Start date
Jan 16, 2023
Primary completion
Dec 2026 (estimated)
Completion
Jul 2027 (estimated)
Last update
Mar 18, 2026

Study contacts

Sandra Raab, Dr.
Contact
sandra.raab@kepleruniklinikum.at
+43 (0)5 7680 83 - 78470
Andreas Shamiyeh, Dr.
Contact
andreas.shamiyeh@kepleruniklinikum.at
+43 (0)5 7680 83 - 2133
Andreas Shamiyeh, Dr.
principal investigator · Kepler University Hospital Linz

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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