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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative treatment | Active Comparator | Written lifestyle guidance and fiber supplements |
|
| Elective laparoscopic sigmoid resection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective laparoscopic sigmoid resection | Procedure |
| ||
| Conservative treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal quality of life-index change at 6 months | Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization. | 6 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| GIQLI at 12, 24, 48, and 96 months | 12, 24, 48, and 96 months from randomization | |
| Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months | 6, 12, 24, 48, and 96 months from randomization |
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Inclusion Criteria:
OR
OR
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ville Sallinen, M.D., Ph.D. | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital, Jorvi Hospital | Espoo | Finland | ||||
| Kanta-Häme Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40202724 | Derived | 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. | |
| 37074706 | Derived |
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| Dietary Supplement |
Written lifestyle guidance and fiber supplements |
|
| Recurrence and severity of recurrent diverticulitis | 0 - 96 months from randomization |
| 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. | 0 - 96 months from randomization |
| 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. | 0 - 96 months from randomization |
| Complications due to elective sigmoid resection | 0 - 96 months from randomization |
| Mortality | 0 - 96 months |
| Complications of diverticular disease | 0 - 96 months |
| Stoma rate | 0 - 96 months from randomization |
| Hämeenlinna |
| Finland |
| Helsinki University Central Hospital | Helsinki | Finland |
| North Carelia Central Hospital | Joensuu | Finland |
| Keski-Suomi Central Hospital | Jyväskylä | Finland |
| Kuopio University Central Hospital | Kuopio | Finland |
| Päijät-Häme Central Hospital | Lahti | Finland |
| Oulu University Hospital | Oulu | Finland |
| Etelä-Pohjanmaa Central Hospital | Seinäjoki | Finland |
| Turku University Central Hospital | Turku | Finland |
| Vaasa Central Hospital | Vaasa | Finland |
| 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. |
| 33206182 | Derived | 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. |
| ID | Term |
|---|---|
| D004240 | Diverticulum |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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