Diverticulitis of SigmoidNCT03994978
Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis
An observational study of Diverticulitis of Sigmoid, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis of Sigmoid
- What is being tested?
- elective sigmoidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 252 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jul 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent episodes of diverticulitis with indication of further treatment.The physician decides which therapy (conservative or surgical) will be carried out.
Who may be able to join
- 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
Who cannot join
- Patients aged under 18.
- Patients unable to understand an informed consent.
- Patients with chronic pain disorder.
- Patients with sigmoid fistulas
- Emergency operations.
- Pregnant women or lactation.
- Patients with other severe gastrointestinal diseases, such as inflammatory bowel diseases (IBD), carcinoma or immunologic disorders.
- Patients unable to perform surgery or high-risk patients according to the American Society of Anesthesiology (ASA 4 grade or higher)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
St. Claraspital Basel
Basel
Daniel Steinemann, MD, daniel.steinemann@clarunis.ch
About this study
Official title: Preoperative vs. Postoperative Bowel Function and Quality of Life in Patients Undergoing Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis (FRESCO-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.
Read the detailed description
The prevalence of diverticular disease of sigmoid in the Western has increased over the past century and our know-how of this disease and its management continues to evolve. International experts have tried to standardize the surgical approach to patients with recurrent episodes of sigmoid diverticulitis but, to date, no guidelines are universally recognized.The American Society of Colon and Rectal Surgeons (ASCRS) and the World Society of Emergency Surgery (WSES) recommend an individualized approach after recovery from uncomplicated acute diverticulitis to plan an elective sigmoid resection. The impact of ongoing disorders on quality of life (QoL) and not the number of previous episodes of diverticulitis should be the most determining factor. The German guideline by the Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV) recommend an elective sigmoid resection after a careful risk/benefit assessment depending on the clinical presentation in the disease-free interval in patients with chronic relapsing diverticulitis.The Danish Surgical Society (DSS) is more restrained and mentions the unnecessary risk in terms of morbidity and mortality to the individual as well as costs to society in prophylactic resection of the sigmoid. Therefore, they recommend that elective surgery should be probably limited to symptomatic cases not amenable to conservative measures. Moreover, recent studies have demonstrated that the number of attacks of diverticulitis is not necessarily a prevailing factor in defining the suitability of surgery and the operation itself carries significant morbidity and mortality. The German guidelines describe also a persistence of the symptoms in patients who underwent sigmoid resection in 22-25%. An uncomplicated diverticulitis is generally considered a mild and self-limiting disease, performing a potentially harmful procedure in these patients does not seem justified. However, elective resection may be an appropriate solution for a more selective group of patients who suffer greatly from their disease. Many studies have consistently shown that 40-80% remain symptomatic after conservative treatment, leading to impaired health-related Quality of life (HRQoL) and increased costs.
- Conditions
- Diverticulitis of Sigmoid
- Being tested
- elective sigmoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective sigmoidectomyProcedure or surgery
elective sigmoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Patients with uncomplicated recurrent diverticulitis undergoing elective sigmoid resection Receives: Procedure: elective sigmoidectomy | |
| Conservative group | Patients with uncomplicated recurrent diverticulitis with conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline to 12 months after intervention
Change in grade of constipation
Constipation measured by total "Cleveland constipation score" ranging from 0 to 30; lower values represent better outcome
Measured: change from baseline to 12 months after intervention
Secondary outcomes (2)
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
Measured: change from baseline to 12 months after intervention
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
Measured: change from baseline to 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start8 Jul 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticulitis of SigmoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Wölnerhanssen, MD, Study chair, St. Clara Research Ltd.Daniel Steinemann, MD, Principal investigator, Clarunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994978
- Sponsor's protocol ID
- FRESCO Trial
- Status last verified
- May 2026
- First submitted
- 19 Jun 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative vs. Postoperative Bowel Function and Quality of Life in Patients Undergoing Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis (FRESCO-Trial)
- ClinicalTrials.gov ID
- NCT03994978
- Acronym / sponsor ID
- FRESCO Trial
- Conditions
- Diverticulitis of Sigmoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of diverticular disease of sigmoid in the Western has increased over the past century and our know-how of this disease and its management continues to evolve. International experts have tried to standardize the surgical approach to patients with recurrent episodes of sigmoid diverticulitis but, to date, no guidelines are universally recognized.The American Society of Colon and Rectal Surgeons (ASCRS) and the World Society of Emergency Surgery (WSES) recommend an individualized approach after recovery from uncomplicated acute diverticulitis to plan an elective sigmoid resection. The impact of ongoing disorders on quality of life (QoL) and not the number of previous episodes of diverticulitis should be the most determining factor. The German guideline by the Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV) recommend an elective sigmoid resection after a careful risk/benefit assessment depending on the clinical presentation in the disease-free interval in patients with chronic relapsing diverticulitis.The Danish Surgical Society (DSS) is more restrained and mentions the unnecessary risk in terms of morbidity and mortality to the individual as well as costs to society in prophylactic resection of the sigmoid. Therefore, they recommend that elective surgery should be probably limited to symptomatic cases not amenable to conservative measures. Moreover, recent studies have demonstrated that the number of attacks of diverticulitis is not necessarily a prevailing factor in defining the suitability of surgery and the operation itself carries significant morbidity and mortality. The German guidelines describe also a persistence of the symptoms in patients who underwent sigmoid resection in 22-25%. An uncomplicated diverticulitis is generally considered a mild and self-limiting disease, performing a potentially harmful procedure in these patients does not seem justified. However, elective resection may be an appropriate solution for a more selective group of patients who suffer greatly from their disease. Many studies have consistently shown that 40-80% remain symptomatic after conservative treatment, leading to impaired health-related Quality of life (HRQoL) and increased costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | – | Procedure: elective sigmoidectomyPatients with uncomplicated recurrent diverticulitis undergoing elective sigmoid resection |
| Conservative group | – | –Patients with uncomplicated recurrent diverticulitis with conservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent episodes of diverticulitis with indication of further treatment.The physician decides which therapy (conservative or surgical) will be carried out.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Patients aged under 18.
- Patients unable to understand an informed consent.
- Patients with chronic pain disorder.
- Patients with sigmoid fistulas
- Emergency operations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elective sigmoidectomyelective sigmoidectomy | Procedure or surgery | Surgical group |
Primary outcome
Change in grade of fecal incontinence incontinence score
Time frame: change from baseline to 12 months after intervention
Fecal incontinence measured by total "Vaizey-Wexner incontinence score" ranging from 0 to 24; lower values represent better outcome
Change in grade of constipation
Time frame: change from baseline to 12 months after intervention
Constipation measured by total "Cleveland constipation score" ranging from 0 to 30; lower values represent better outcome
2 secondary outcomes
Change in gastrointestinal quality of Life: gastrointestinal quality of life score" (GIQLI score)
Time frame: change from baseline to 12 months after intervention
Change in erectile function
Time frame: change from baseline to 12 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bettina Wölnerhanssen, MD study chair
St. Clara Research Ltd.
Daniel Steinemann, MD principal investigator
Clarunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulitis of Sigmoid, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bettina Wölnerhanssen, MD (0041616858585, bettina.woelnerhanssen@claraspital.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in grade of fecal incontinence incontinence score (time frame: change from baseline to 12 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.