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NCT Number: NCT05393609

Quality of Life and Surgery in Diverticular Disease

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.

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Key information

Conditions

Diverticulitis Colon Colonic Diseases Digestive System Diseases Diverticular Disease of Left Side of Colon Diverticular Diseases Diverticulitis Diverticulitis, Colonic Diverticulosis, Colonic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Randers Regional Hospital

Randers, Central Jutland, 8930, Denmark

Location status: Recruiting

Location contact

Helene R Dalby, MD

CONTACT

[email protected]

+4526353245

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Referred to surgical clinic due to diverticular disease
  • Colonic diverticula verified by CT or endoscopy

Exclusion criteria

  • 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

Treatment and study plan

Sigmoidectomy

Procedure

Conventional laparoscopic resection of the sigmoid colon

Conservative

Dietary Supplement

According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.

Primary outcomes

  1. 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).

  2. Disease-specific quality of life

    Time frame: Baseline.

    Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).

Secondary outcomes

  1. Generic quality of life

    Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

    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).

  2. Bowel function

    Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

    Patient-assessment of constipation symptoms (PAC-SYM) 12 items. Total score 0-50 (0=best, 50=worst).

  3. Bowel function

    Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

    Low anterior resection syndrome score (LARS score) 5 items. Total score 0-42 (0=best, 42=worst).

  4. Pain related to diverticular disease

    Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

    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).

  5. Urinary dysfunction - females

    Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

    International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (CIQ-FLUTS) 13 items. Total score 0-52 (0=best, 52=worst).

  6. Urinary dysfunction - males

    Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

    International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) 14 items. Total score 0-56 (0=best, 56=worst).

  7. Sexual dysfunction - females

    Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

    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).

  8. Sexual dysfunction - males

    Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

    The International Index of Erectile Function Questionnaire (IIEF) 15 items. Total score 0-65 (0= worst, 65= best).

  9. Postoperative morbidity

    Time frame: 30 days

    Postoperative complications classified according to the Clavien-Dindo classification

  10. Postoperative mortality

    Time frame: 30 days

    Mortality within the postoperative period

Study contacts

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

Helene R Dalby, MD

CONTACT

[email protected]

+45 42 65 93 92

Katrine J Emmertsen, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Randers Regional Hospital

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 26, 2022
Registry last updated
May 12, 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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