NCT00687570

Brief Summary

Traditionally bowel preparation before surgery of rectal cancer could be troublesome for patients especially for patients with kidney and cardio- vascular diseases, where salt and electrolyte balance can be a problem. Cleaning the bowel without complications for the patient is one of the aims for this study. The other aim is to see if patient nutritional status improves with nutritional drinks as a complement to food intake 4-6 weeks before surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

6 years

First QC Date

May 28, 2008

Last Update Submit

February 19, 2015

Conditions

Rectal Cancer

Keywords

patients with rectal cancer undergoing surgeryBowel purity degreeBowel preparationRectal cancerNutritional statuscomplications with traditional bowel preparationComplicationsPhysiological status

Outcome Measures

Primary Outcomes (1)

  • Bowel purity degree

    day of surgery

Secondary Outcomes (3)

  • Nutritional status

    before and after operation

  • Complications

    day of surgery and days after surgery

  • physiological function

    before and after surgery

Study Arms (2)

B

OTHER

Nutritional drinks 7 days before surgery instead of traditional Bowel preparation with Laxabon®

Dietary Supplement: Fresubin Energy Drink

A

OTHER

Traditional bowel preparation with Laxabon®

Drug: Laxabon®

Interventions

Fresubin Energy DrinkDIETARY_SUPPLEMENT

Fresubin energy drink 30 kcal/kg\*dag-1, seven days before surgery

B
Laxabon®DRUG

Laxabon® 4 litres starting the day before surgery

A

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • rectal cancer
  • men
  • women
  • age 18-90 years

You may not qualify if:

  • acute ileus
  • seriously dementia
  • metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Department, Ersta Hospital

Stockholm, SE116 91, Sweden

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ulf Gustafsson, MD, PhD

    Karolinska Institut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 2, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

SE(1)