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NCT Number: NCT05942833

Quality of Life 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordensklinikum Elisabethinen Linz, Linz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • < 18 years
  • Pregnancy
  • BMI > 55kg/m2
  • Current colorectal carcinoma in the left-sided colon
  • Oral and/or intravenous corticosteroid
  • 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

Treatment and study plan

Sigmoid Resection

Procedure

Timing of sigmoid resection

Primary outcomes

  1. Gastrointestinal Quality of Life Index

    Time frame: Up to 18 weeks

    Quality of Life

Secondary outcomes

  1. SF-36 score (Short form score)

    Time frame: Up to 18 weeks

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

  2. Low anterior resection syndrome score

    Time frame: Up to 18 weeks

    points (0-40), the lower the better

  3. Anastomosis insufficiency

    Time frame: Up to 18 weeks

    yes/no

  4. Intraoperative complication

    Time frame: Up to 18 weeks

    bleeding, ureter harming (yes/no)

  5. Exitus

    Time frame: Up to 18 weeks

    yes/no

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

    Time frame: Up to 18 weeks

    days

  7. Earlier readmission due to recurrence while waiting for surgery

    Time frame: Up to 18 weeks

    Only in Group B

  8. Postoperative complication

    Time frame: Up to 18 weeks

    pneumonia, urinary tract infection (yes/no)

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Shamiyeh, Dr.

CONTACT

[email protected]

+43 (0)5 7680 83 - 2133

Sandra Raab, Dr.

CONTACT

[email protected]

+43 (0)5 7680 83 - 78470

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Collaborators

  • Elisabethinen Hospital
  • Krankenhaus Barmherzige Schwestern Linz
  • Universitätsmedizin Mannheim

Registry information

Official study title

DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis

Acronym: DATE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 12, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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