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Quality of Life and Surgery in Diverticular Disease

ConditionsDiverticulitis ColonQuality of LifeDiverticular Disease of Left Side of Colon
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Referred to surgical clinic due to diverticular disease

Colonic diverticula verified by CT or endoscopy

Disqualifiers

Previous colonic resection other than appendectomy

Previous or current colorectal cancer

Previous or current disseminated cancer

Inflammatory bowel disease

Trial population

All patients with recurrent or chronic diverticular disease referred to a surgical department in Central or Northern Denmark Region.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sigmoidectomy

    Procedure/Surgery

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Sigmoidectomy1 intervention
Group B: Conservative1 intervention

Trial outcomes

Primary outcomes

1

Health related quality of life

Gastrointestinal Quality of Life (GIQLI) 36 items. Total score 0-144 (0=worst, 144=best).

Time frame
Change from baseline to 1 year follow-up.
2

Disease-specific quality of life

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

Time frame
Baseline.

Secondary outcomes

1

Generic quality of life

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).

Time frame
Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
2

Bowel function

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

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

Bowel function

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

Time frame
Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
4

Pain related to diverticular disease

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).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Randers Regional Hospital

Collaborator

Source ClinicalTrials.gov
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