Trial document




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  DRKS00004544

Trial Description

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Title

Effect of foot reflexology on the restitution of intestinal motility after laparoscopic Hemicolectomy

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Trial Acronym

RZF

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URL of the Trial

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Brief Summary in Lay Language

Foot reflexology (RZF) is a physiotherapeutic treatment developed in the course of many years from old popular knowledges to an exactly therapy.
At the foot are represented , as so-called zones, all organs and systems of the body in a reduced scale. The physiotherapists work aimed in the foot tissue with special handles (like a massage) without application of devices and adjuvants. This treatment is painless and is perceived as very comfortable. In our clinic, we use the foot reflexology to increase the intestinal activity after abdominal surgical intervention in order to accelerate the recovery. Included in the study are patient with bowel tumor undergoing surgery. The patients are divided into 2 groups: a group receives the RZF, the other group not. Information about the intestinal activity are collected. Goal of our study is to proof the effectiveness of the RZF on the intestinal activity.

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Brief Summary in Scientific Language

Foot reflexology (RZF) is a physiotherapeutic treatment developed in the course of many years from old popular knowledges to an exactly complementary and supportive therapy.
It is based on the idea that all organs and systems of man are represented in a reduced scale, as so-called zones, at the foot. The RZF is part of the repertoire of the physiotherapeutic concept in our clinic and is used therapeutically to treat paralytic or post-operative ileus. With our study we want to investigate the prophylactic effectiveness of the RZF on the intestines motility after standardized surgical interventions, namely laparoscopic hemicolectomies for coloncarcinom.
Will be selected 134 right hemicolectomies and 134 left hemicolectomies (emergency surgery, patients unable to give consent, patients without solid meal preoperativ, stomata patients, immobility are excluded). The randomization occurs trough a randomization program into a treatment and control group immediately after the operation.
The RZF-group´s patients will be treated with the RZF (foot reflexology) at the first postoperative day and daily up to complete oral intake and defaecation; if required they receive in addiction prokinetic drugs.
The control-group´s patients do not receive RZF, but exclusively drugs at the first postoperative day.
Clinical information about the intestinal peristalsis (by Residentwith stethoscope twice daily), necessity of an additional prokintetic drugs, time of the first flatus and the first defecation, pains (1-10 corresponds to the analogous scale), subjective feeling of the patient during the RZF, return to solid food (liquid, mushy, solid food), appearance of vegetative reactions (nausea, vomiting), necessity of a stomach tube (quantity and quality) . In addiction will be collected demographic and operation parameters, e.g. age, sex, BMI, previous abdominal operations, ASA, number of drugs, tumor stadium UICC, number of Lymph nodes, duration of operation, number of postoperative general or specific complications (conversion, bleeding, anastomotic insufficiency, relaparotomy, etc.). Primary outcome is the length of stay. The sample size calculation assumes a reduction of a day in the duration of stay in hospitalthrough RZF. Secondary end-points are parameters of the gastrointestinal convalescence.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004544
  •   2013/01/07
  •   [---]*
  •   yes
  •   Approved
  •   342/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1136-9260 
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   K56.0 -  Paralytic ileus
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Interventions/Observational Groups

  •   The RZF-group´s patients will be trated with the RZF (foot reflexology) at the first postoperative day and daily up to complete oral intake and defaecation; if required they receive in addiction prokinetic drugs. A RZF-unit takes ca. 15 minutes
  •   The control-group´s patients do not receive RZF, but exclusively drugs
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Time to readiness for hospital discharge (accordig to objective criteria: peristaltic, flatus, defaecation, solid food)

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Secondary Outcome

Restitution of intestinal motility (solid food, normal defaecation)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/01/15
  •   268
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Elective (right or links) Hemicolectomy for colon cancer

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Exclusion Criteria

Emergency surgery, Patients unable to give consent, Patients without solid meal preoperativ, Stoma, Immobility

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Allgemein-. Viszeral,- Kinderchirurgie
    • Mr.  Prof. Dr med Dr h.c.  Norbert  Runkel 
    • Vöhrenbacherstraße 23
    • 78050  Villingen-Schwenningen
    • Germany
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    • Schwarzwald-Baar Klinikum Villingen-Schwenningen Allgemein-, Viszeral- und Kinderchirurgie
    • Mr.  Prof. Dr med Dr h.c.   Norbert  Runkel 
    • Vöhrenbacherstraße 23
    • 78050  Villingen
    • Germany
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    • Schwarzwald-Baar Klinikum Villingen-Schwenningen Allgemein-, Viszeral- und Kinderchirurgie
    • Gabriele  Quaranta 
    • Vöhrenbacherstraße 23
    • 78050  Villingen
    • Germany
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Sources of Monetary or Material Support

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    • Schwarzwald-Baar Klinikum Villingen-Schwenningen Allgemein-, Viszeral- und Kinderchirurgie
    • Vöhrenbacherstraße 23
    • 78050  Villingen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.