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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174926
Recruitment Status : Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ville Sallinen, Helsinki University Central Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Diverticulum Colon, Sigmoid Procedure: Elective laparoscopic sigmoid resection Dietary Supplement: Conservative treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
Study Start Date : September 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conservative treatment
Written lifestyle guidance and fiber supplements
Dietary Supplement: Conservative treatment
Written lifestyle guidance and fiber supplements

Experimental: Elective laparoscopic sigmoid resection Procedure: Elective laparoscopic sigmoid resection



Primary Outcome Measures :
  1. Gastrointestinal quality of life-index change at 6 months [ Time Frame: 6 months from randomization ]
    Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.


Secondary Outcome Measures :
  1. GIQLI at 12, 24, 48, and 96 months [ Time Frame: 12, 24, 48, and 96 months from randomization ]
  2. 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 ]
  3. Recurrence and severity of recurrent diverticulitis [ Time Frame: 0 - 96 months from randomization ]
  4. Need of emergency surgery due to diverticulitis [ Time Frame: 0 - 96 months from randomization ]
    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.

  5. Need of elective sigmoid resection due to diverticulitis (conservative arm) [ Time Frame: 0 - 96 months from randomization ]
    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.

  6. Complications due to elective sigmoid resection [ Time Frame: 0 - 96 months from randomization ]
  7. Mortality [ Time Frame: 0 - 96 months ]
  8. Complications of diverticular disease [ Time Frame: 0 - 96 months ]
  9. Stoma rate [ Time Frame: 0 - 96 months from randomization ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174926


Locations
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Finland
Helsinki University Central Hospital, Jorvi Hospital
Espoo, Finland
Helsinki University Central Hospital
Helsinki, Finland
Kanta-Häme Central Hospital
Hämeenlinna, 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
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Ville Sallinen, M.D., Ph.D. Helsinki University Central Hospital
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Responsible Party: Ville Sallinen, M.D., Ph.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02174926    
Other Study ID Numbers: LASERtrial
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Diverticulitis
Diverticulum
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical