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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

Tracking Information
First Submitted Date  ICMJE June 22, 2014
First Posted Date  ICMJE June 26, 2014
Last Update Posted Date May 1, 2019
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
  • GIQLI at 12, 24, 48, and 96 months [ Time Frame: 12, 24, 48, and 96 months from randomization ]
  • 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 ]
  • Recurrence and severity of recurrent diverticulitis [ Time Frame: 0 - 96 months from randomization ]
  • 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.
  • 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.
  • Complications due to elective sigmoid resection [ Time Frame: 0 - 96 months from randomization ]
  • Mortality [ Time Frame: 0 - 96 months ]
  • Complications of diverticular disease [ Time Frame: 0 - 96 months ]
  • Stoma rate [ Time Frame: 0 - 96 months from randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
Official Title  ICMJE LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diverticulum
  • Colon, Sigmoid
Intervention  ICMJE
  • Procedure: Elective laparoscopic sigmoid resection
  • Dietary Supplement: Conservative treatment
    Written lifestyle guidance and fiber supplements
Study Arms  ICMJE
  • Active Comparator: Conservative treatment
    Written lifestyle guidance and fiber supplements
    Intervention: Dietary Supplement: Conservative treatment
  • Experimental: Elective laparoscopic sigmoid resection
    Intervention: Procedure: Elective laparoscopic sigmoid resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2014)
133
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02174926
Other Study ID Numbers  ICMJE LASERtrial
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ville Sallinen, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ville Sallinen, M.D., Ph.D. Helsinki University Central Hospital
PRS Account Helsinki University Central Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP