- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553121
Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.
July 10, 2019 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Jinekolojik Kanserler Nedeni Ile Opere Edilen Hastalarda Preoperatif yürümenin Postoperatif Barsak fonksiyonlarına Etkisi
Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with gynecologic cancers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34000
- Bakirkoy Dr. Sadi Konuk Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
walking and not walking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the time to the first passage of flatus after surgery
Time Frame: 6 hours- 5 days
|
Doctor will detect the time with auscultation
|
6 hours- 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the time to first defecation
Time Frame: 6 hours- 7 day
|
Doctor will detect the time with auscultation
|
6 hours- 7 day
|
time to first bowel movement
Time Frame: 6 hours- 5 days
|
Doctor will detect the time with auscultation
|
6 hours- 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gungorduk K, Ozdemir IA, Gungorduk O, Gulseren V, Gokcu M, Sanci M. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial. Am J Obstet Gynecol. 2017 Feb;216(2):145.e1-145.e7. doi: 10.1016/j.ajog.2016.10.019. Epub 2016 Oct 22.
- Ozdemir IA, Comba C, Demirayak G, Gulseren V, Erdogan SV, Aslanova F, Afsar S, Gungorduk K. Impact of pre-operative walking on post-operative bowel function in patients with gynecologic cancer. Int J Gynecol Cancer. 2019 Oct;29(8):1311-1316. doi: 10.1136/ijgc-2019-000633. Epub 2019 Jul 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
June 28, 2018
Study Registration Dates
First Submitted
May 27, 2018
First Submitted That Met QC Criteria
June 11, 2018
First Posted (Actual)
June 12, 2018
Study Record Updates
Last Update Posted (Actual)
July 12, 2019
Last Update Submitted That Met QC Criteria
July 10, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2017/223
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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