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Recruiting NCT05393609

Quality of Life and Surgery in Diverticular Disease

— Observational Diverticulitis Colon Quality of Life Diverticular Disease of Left Side of Colon

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sigmoidectomy, Conservative.
Who it may be relevant to
Registry conditions: Diverticulitis Colon, Quality of Life, Diverticular Disease of Left Side of Colon. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Procedure Sigmoidectomy
    Conventional laparoscopic resection of the sigmoid colon
  • Dietary supplement Conservative
    According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.

Primary outcome measures

  • Health related quality of life [Time frame: Change from baseline to 1 year follow-up.]
  • Disease-specific quality of life [Time frame: Baseline.]
Secondary outcome measures (10)
  • Generic quality of life [Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Bowel function [Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Bowel function [Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Pain related to diverticular disease [Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Urinary dysfunction - females [Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Urinary dysfunction - males [Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Sexual dysfunction - females [Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Sexual dysfunction - males [Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Postoperative morbidity [Time frame: 30 days]
  • Postoperative mortality [Time frame: 30 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Randers Regional Hospital — Randers

Identifiers

NCT: NCT05393609 · Life with diverticular disease

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗