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NCT Number: NCT02174926

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diverticulum Colon, Sigmoid Digestive System Diseases Diverticular Diseases Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Jorvi Hospital, Espoo, Finland

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Elective laparoscopic sigmoid resection

Procedure

conservative treatment

Dietary Supplement

Written lifestyle guidance and fiber supplements

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Acronym: LASER

Important dates

Study start
2014
Primary completion
2019
Study completion
2027
First posted
Jun 26, 2014
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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