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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02174926 |
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Date of registration:
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22/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
LASER |
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Scientific title:
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LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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133 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02174926 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Ville Sallinen, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University Central Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diverticulum
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Colon, Sigmoid
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Intervention(s)
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Dietary Supplement: Conservative treatment
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Procedure: Elective laparoscopic sigmoid resection
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Primary Outcome(s)
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Gastrointestinal quality of life-index change at 6 months
[Time Frame: 6 months from randomization]
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Secondary Outcome(s)
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Stoma rate
[Time Frame: 0 - 96 months from randomization]
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GIQLI at 12, 24, 48, and 96 months
[Time Frame: 12, 24, 48, and 96 months from randomization]
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Recurrence and severity of recurrent diverticulitis
[Time Frame: 0 - 96 months from randomization]
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Need of elective sigmoid resection due to diverticulitis (conservative arm)
[Time Frame: 0 - 96 months from randomization]
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Mortality
[Time Frame: 0 - 96 months]
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Need of emergency surgery due to diverticulitis
[Time Frame: 0 - 96 months from randomization]
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Complications due to elective sigmoid resection
[Time Frame: 0 - 96 months from randomization]
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Complications of diverticular disease
[Time Frame: 0 - 96 months]
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Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months
[Time Frame: 6, 12, 24, 48, and 96 months from randomization]
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Secondary ID(s)
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LASERtrial
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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