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Quality of Life and Surgery in Diverticular Disease

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ClinicalTrials.gov Identifier: NCT05393609
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
Sponsor:
Collaborator:
Randers Regional Hospital
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Diverticulitis Colon Quality of Life Diverticular Disease of Left Side of Colon Procedure: Sigmoidectomy Dietary Supplement: Conservative

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Quality of Life and Surgery in Diverticular Disease
Actual Study Start Date : April 22, 2022
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Sigmoidectomy
Patients with diverticular disease undergoing elective resection of the sigmoid colon
 Procedure: Sigmoidectomy
Conventional laparoscopic resection of the sigmoid colon
Conservative
Patients with diverticular disease not referred to surgery, but conservative treatment
 Dietary Supplement: Conservative
According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with recurrent or chronic diverticular disease referred to a surgical department in Central or Northern Denmark Region.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05393609


Contacts
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Contact: Helene R Dalby, MD +45 42 65 93 92 helecl@rm.dk
Contact: Katrine J Emmertsen, MD, PhD katremme@rm.dk

Locations
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Denmark
Randers Regional Hospital Recruiting
Randers, Central Denmark Region, Denmark, 8930
Contact: Helene R Dalby, MD    +4526353245    helecl@rm.dk   
Sponsors and Collaborators
University of Aarhus
Randers Regional Hospital
Investigators
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Principal Investigator: Helene R Dalby, MD Randers Regional Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT05393609    
Other Study ID Numbers: Life with diverticular disease
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Diverticulum
Diverticulitis, Colonic
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Pathological Conditions, Anatomical
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases