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Active, Not Recruiting

NCT Number: NCT04281667

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rectal Adenocarcinoma Colonic Diseases Colorectal Cancer Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Neoplasms Rectum Carcinoma Rectum Neoplasm Surgery--Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Hospital, Helsinki, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for anterior rectal resection with primary anastomosis

Exclusion criteria

  • Emergency operation
  • Bowel obstruction
  • Existing stoma
  • Other reason preventing mechanical bowel preparation
  • Allergy to neomycin or metronidazole
  • Age < 18 years
  • Lack of co-operation

Exclusion criteria

after randomization:

  • Patient did not undergo surgery
  • Anterior resection was not performed
  • Colonic anastomosis was not performed

Treatment and study plan

Oral Antibiotics

Drug

Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)

Placebo

Drug

Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)

Mechanical Bowel Preparation

Drug

Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Primary outcomes

  1. Comprehensive Complication Index

    Time frame: Within 30 days from surgery

    Comprehensive Complication Index score

Secondary outcomes

  1. Surgical Site Infection

    Time frame: Within 30 days from surgery

    Surgical site infection as defined by CDC

  2. Anastomotic dehiscence

    Time frame: Within 30 days from surgery

    Anastomotic dehiscence

  3. Lenght of hospital stay

    Time frame: Within hospital stay, estimated on average 7 days

    Lenght of hospital stay

  4. Mortality

    Time frame: Within 90 days from surgery

    Mortality

  5. Adjuvant therapy

    Time frame: Within 6 months from surgery

    Patients receiving adjuvant therapy divided by patients needing adjuvant therapy

Other outcomes

  1. 5-year overall survival

    Time frame: 5 years from surgery

    5-year overall survival

  2. 5-year disease specific survival

    Time frame: 5 years from surgery

    5-year disease specific survival

  3. 5-year recurrence free survival

    Time frame: 5 years from surgery

    5-year recurrence free survival

  4. Quality of life (SF-36)

    Time frame: At randomization and at one year from surgery

    Difference in quality of life between baseline and 1 year measured using SF-36

  5. Quality of life (QLQ-C30)

    Time frame: At randomization and at one year from surgery

    Difference in quality of life between baseline and 1 year measured using QLQ-C30

  6. Quality of life (QLQ-CR29)

    Time frame: At randomization and at one year from surgery

    Difference in quality of life between baseline and 1 year measured using QLQ-CR29

  7. Quality of life (LARS)

    Time frame: At randomization and at one year from surgery

    Difference in quality of life between baseline and 1 year measured using LARS

  8. Adverse effects of antibiotics

    Time frame: Within 30 days from surgery

    Adverse effects of antibiotics

  9. Bowel microbiota

    Time frame: Before, at, 6 months, and 1 year after surgery.

    Bowel microbiota

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial

Acronym: MOBILE2

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
Feb 24, 2020
Registry last updated
Nov 17, 2022

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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