Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

The decision to perform a surgical intervention or not after recovery from repeated uncomplicated episodes of acute diverticulitis remains controversial and the literature shows different conflicting approaches based on low-quality evidence.The goal of this trial is to achieve a better understanding of the impact of surgery on bowel function and QoL in patients with recurrent uncomplicated sigmoid diverticulitis in order to develop treatment guidelines.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with recurrent uncomplicated diverticulitis and surgical indication for sigmoid resection

Patients with recurrent uncomplicated diverticulitis and non-surgical indication for conservative management

Confirmation of at least one episode of acute uncomplicated diverticulitis in computed tomography

Disqualifiers

Patients aged under 18.

Patients unable to understand an informed consent.

Patients with chronic pain disorder.

Patients with sigmoid fistulas

Trial population

Patients with recurrent episodes of diverticulitis with indication of further treatment.The physician decides which therapy (conservative or surgical) will be carried out.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • elective sigmoidectomy

    Procedure/Surgery

    elective sigmoidectomy

Treatment groups

252 Participants
are divided into 2 treatment groups
Group A: Surgical group1 intervention
Group B: Conservative group0 interventions

Trial outcomes

Primary outcomes

1

Change in grade of fecal incontinence incontinence score

Fecal incontinence measured by total "Vaizey-Wexner incontinence score" ranging from 0 to 24; lower values represent better outcome

Time frame
change from baseline to 12 months after intervention
2

Change in grade of constipation

Constipation measured by total "Cleveland constipation score" ranging from 0 to 30; lower values represent better outcome

Time frame
change from baseline to 12 months after intervention

Secondary outcomes

1

Change in gastrointestinal quality of Life: gastrointestinal quality of life score" (GIQLI score)

Gastrointestinal quality of life measured by total "gastrointestinal quality of life score" (GIQLI score) ranging from 0-144; higher values represent better outcome

Time frame
change from baseline to 12 months after intervention
2

Change in erectile function

Erectile function measured by total "international index of erectile function" (IIEF-5-score) ranging from 5 to 25; higher values represent better outcome

Time frame
change from baseline to 12 months after intervention

Other outcomes

Sponsors and contacts

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