Clinical trial NCT00687570: Bowel Preparation Before Rectal Cancer Surgery
Official title: Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation Before Rectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: patients with rectal cancer undergoing surgery
Bowel purity degree
Bowel preparation
Rectal cancer
Nutritional status
complications with traditional bowel preparation
Complications
Physiological status
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2008-06-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Detailed description: In our institution, patients undergoing surgery for cancer in the rectum are often prepared with energy drinks in order to receive a higher energy level before the operation. As a result of this the patients often avoid nausea and have a better intestinal function after surgery and less complications. We think that this treatment has worked well on the patients but no scientific studies have been done on these patients. As a complementary result of the treatment with nutritional drinks we have found that the colon is empty already after a short time of treatment.

The actual study's purpose is to find out if rectal cancer surgery can be performed without traditionally bowel preparation. Nutritional drinks are to be used instead of traditional bowel preparation. Patients are randomized into two groups, stratification for stricture, malnutrition and laparoscopic surgery and each group should either bee treated with traditional bowel preparation, Laxabon® (A) or nutritional drinks, Fresubin Energy drink (B) before surgery. Patients in subgroup B take nutritional drinks seven days before surgery instead of ordinary food. Bowel purity degree is measured peroperatively.

The secondary aim is to see if malnutrition can be improved with nutritional drinks as a complement to ordinary food intake before surgery. For four to six weeks before surgery 50 % or more of the caloric need is substituted with nutritional drinks in subgroup B (Fresubin Energy drink 15-30 kcal/kg\*day). Subgroup A only eats ordinary food throughout the same period, before surgery.

Bowel purity degree, physiological functions, and body mass index are measured in all four groups before and after surgery. All patients in the study keep records of physical activity daily, and food diary twice a week. Complications are registered.

Blood samples for hormones and electrolytes are taken before and after surgery.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* acute ileus
* seriously dementia
* metastatic disease

Primary outcomes:
measure: Bowel purity degree
timeFrame: day of surgery
Secondary outcomes:
measure: Nutritional status
timeFrame: before and after operation
measure: Complications
timeFrame: day of surgery and days after surgery
measure: physiological function
timeFrame: before and after surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Department, Ersta Hospital
Study officials:
affiliation: Karolinska Institut
name: Ulf Gustafsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: