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Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553121
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Description
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Brief Summary:
Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with gynecologic cancers.

Condition or disease Intervention/treatment Phase
Postoperative Bowel Functions Other: walking Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: walking preoperatively not walking preoperatively
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Doctor who evaluate bowel function will not know whether patients walked or not
Primary Purpose: Prevention
Official Title: Jinekolojik Kanserler Nedeni Ile Opere Edilen Hastalarda Preoperatif yürümenin Postoperatif Barsak fonksiyonlarına Etkisi
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Walk preoperativelying
Patients will be operated gynecologic cancers and have American Society of Anesthesia score 1 or 2. Subjects will walk during one hour with average speed 3 km/hour 12 hour before surgery.
 Other: walking
walking and not walking
Active Comparator: not walking preoperatively
Patients will be operated gynecologic cancers and have American Society of Anesthesia score 1 or 2. Subjects will not walk preoperatively.
 Other: walking
walking and not walking


Outcome Measures
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Primary Outcome Measures :
  1. the time to the first passage of flatus after surgery [ Time Frame: 6 hours- 5 days ]
    Doctor will detect the time with auscultation


Secondary Outcome Measures :
  1. the time to first defecation [ Time Frame: 6 hours- 7 day ]
    Doctor will detect the time with auscultation

  2. time to first bowel movement [ Time Frame: 6 hours- 5 days ]
    Doctor will detect the time with auscultation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with gynecological cancer ASA score 1 or 2 via laparascopy or laparatomy

Exclusion Criteria:

  • ASA score >2 orthopedic problems ileostomy or colostomy >24 hours stay in intensive care unit early postoperative complications (relaparotomy, massive blood transfusion)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553121


Locations
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Turkey
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey, 34000
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT03553121    
Other Study ID Numbers: 2017/223
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
gynecologic cancer
postoperative bowel function
walking
debulking