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DiverticulumLASERNCT02174926

LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial

A study testing Elective laparoscopic sigmoid resection and Conservative treatment in people with Diverticulum and Colon, Sigmoid, run by Helsinki University Central Hospital at 11 sites in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to find out whether elective sigmoid resection will improve quality of life compared to conservative treatment with lifestyle guidance and fiber supplement in patients with a recurrent or complicated diverticulitis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diverticulum, Colon, Sigmoid
What is being tested?
Elective laparoscopic sigmoid resection and Conservative treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
11 sitesFinland
Study dates
Sep 2014to Dec 2027
Phase
Interventional
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 to 75 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Recurrent left colon diverticulitis (minimum 3 within 2 years, at least 1 confirmed with CT)
  • OR
  • Earlier complicated left colon diverticulitis
  • OR
  • Prolonged (over 3 months) pain or disturbance in bowel habits after a CT-confirmed left colon diverticulitis

Who cannot join

  • Multimorbidity that prevents elective surgery
  • Contraindication to laparoscopy
  • Colonic stricture
  • Fistula (e.g. colocutaneous, colovaginal, colovesical)
  • Active malignancy
  • Earlier resection of sigmoid colon or rectum
Show all 11Show fewer
  • Acute diverticulitis that has not settled
  • Colonoscopy/sigmoidoscopy/virtual colonoscopy not performed within 2 years
  • Age < 18 or > 75 years
  • Pregnancy
  • Inability to answer health surveys (e.g. dementia, psychiatric condition)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Finland11 sites

  • Helsinki University Central Hospital, Jorvi Hospital

    Espoo

  • Kanta-Häme Central Hospital

    Hämeenlinna

  • Helsinki University Central Hospital

    Helsinki

  • North Carelia Central Hospital

    Joensuu

  • Keski-Suomi Central Hospital

    Jyväskylä

  • Kuopio University Central Hospital

    Kuopio

  • Päijät-Häme Central Hospital

    Lahti

  • Oulu University Hospital

    Oulu

  • Etelä-Pohjanmaa Central Hospital

    Seinäjoki

  • Turku University Central Hospital

    Turku

  • Vaasa Central Hospital

    Vaasa

Other trials in Finland

About this study

The purpose of this study is to find out whether elective sigmoid resection will improve quality of life compared to conservative treatment with lifestyle guidance and fiber supplement in patients with a recurrent or complicated diverticulitis.

Being tested
Elective laparoscopic sigmoid resection, Conservative treatment
Medical subject headings
Diverticulum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elective laparoscopic sigmoid resectionProcedure or surgery

  • Conservative treatmentDietary supplement

    Written lifestyle guidance and fiber supplements

Study groups in NCT02174926
Study groupRoleWhat they receive
Conservative treatmentActive comparatorWritten lifestyle guidance and fiber supplements
Receives: Dietary Supplement: Conservative treatment
Elective laparoscopic sigmoid resectionExperimentalNot described
Receives: Procedure: Elective laparoscopic sigmoid resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastrointestinal quality of life-index change at 6 months

    Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.

    Measured: 6 months from randomization

Secondary outcomes (9)

  1. GIQLI at 12, 24, 48, and 96 months

    Measured: 12, 24, 48, and 96 months from randomization

  2. Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months

    Measured: 6, 12, 24, 48, and 96 months from randomization

  3. Recurrence and severity of recurrent diverticulitis

    Measured: 0 - 96 months from randomization

  4. Need of emergency surgery due to diverticulitis

    Whether or not patient has undergone emergency surgery due to diverticulitis during follow-up period. Assessment will be carried out by patient questionnaire and search for patient records.

    Measured: 0 - 96 months from randomization

  5. Need of elective sigmoid resection due to diverticulitis (conservative arm)

    Whether or not patient has undergone elective sigmoid resection due to diverticulitis during follow-up period. Assessment will be carried out by patient questionnaire and search for patient records.

    Measured: 0 - 96 months from randomization

  6. Complications due to elective sigmoid resection

    Measured: 0 - 96 months from randomization

  7. Mortality

    Measured: 0 - 96 months

  8. Complications of diverticular disease

    Measured: 0 - 96 months

  9. Stoma rate

    Measured: 0 - 96 months from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionApr 2019
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
133 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02174926
Sponsor's protocol ID
LASERtrial
Acronym
LASER
Status last verified
Aug 2020
First submitted
22 Jun 2014
Last updated
24 Aug 2020
Results posted
No

Publications

  • Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lahdesmaki A, Scheinin T, Sallinen V. Sigmoid Resection vs Conservative Treatment After Diverticulitis: Prespecified 4-Year Analysis of the LASER Randomized Clinical Trial. JAMA Surg. 2025 Jun 1;160(6):615-622. doi: 10.1001/jamasurg.2025.0572.

    PubMed 40202724

  • Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lahdesmaki A, Scheinin T, Sallinen V. Quality-of-Life and Recurrence Outcomes Following Laparoscopic Elective Sigmoid Resection vs Conservative Treatment Following Diverticulitis: Prespecified 2-Year Analysis of the LASER Randomized Clinical Trial. JAMA Surg. 2023 Jun 1;158(6):593-601. doi: 10.1001/jamasurg.2023.0466.

    PubMed 37074706

  • Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lahdesmaki A, Scheinin T, Sallinen V. Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With Diverticulitis: The Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):129-136. doi: 10.1001/jamasurg.2020.5151.

    PubMed 33206182

Questions about this trial

What is this clinical trial studying?

A study testing Elective laparoscopic sigmoid resection and Conservative treatment in people with Diverticulum and Colon, Sigmoid, run by Helsinki University Central Hospital at 11 sites in Finland.

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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Finland. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastrointestinal quality of life-index change at 6 months (time frame: 6 months from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02174926, which also lists 3 linked publications.

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 24 Aug 2020.

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