Postoperative Bowel FunctionsNCT03553121
Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.
A study testing walking in people with Postoperative Bowel Functions, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with gynecologic cancers. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Postoperative Bowel Functions
- What is being tested?
- walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with gynecological cancer ASA score 1 or 2 via laparascopy or laparatomy
Who cannot join
- ASA score >2 orthopedic problems ileostomy or colostomy >24 hours stay in intensive care unit early postoperative complications (relaparotomy, massive blood transfusion)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34000
About this study
Official title: 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.
- Conditions
- Postoperative Bowel Functions
- Being tested
- walking
- Keywords
- gynecologic cancer, postoperative bowel function, walking, debulking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walkingOther
walking and not walking
| Study group | Role | What they receive |
|---|---|---|
| Walk preoperativelying | Active comparator | 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. Receives: Other: walking |
| not walking preoperatively | Active comparator | Patients will be operated gynecologic cancers and have American Society of Anesthesia score 1 or 2. Subjects will not walk preoperatively. Receives: Other: walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to the first passage of flatus after surgery
Doctor will detect the time with auscultation
Measured: 6 hours- 5 days
Secondary outcomes (2)
the time to first defecation
Doctor will detect the time with auscultation
Measured: 6 hours- 7 day
time to first bowel movement
Doctor will detect the time with auscultation
Measured: 6 hours- 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Jan 2018
- Primary completion1 Feb 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Bowel FunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- walking preoperatively not walking preoperatively
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553121
- Sponsor's protocol ID
- 2017/223
- Status last verified
- Jul 2019
- First submitted
- 27 May 2018
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27780709Ozdemir 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.
PubMed 31326951
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jinekolojik Kanserler Nedeni Ile Opere Edilen Hastalarda Preoperatif yürümenin Postoperatif Barsak fonksiyonlarına Etkisi
- ClinicalTrials.gov ID
- NCT03553121
- Acronym / sponsor ID
- 2017/223
- Conditions
- Postoperative Bowel Functions
- Keywords
- gynecologic cancer, postoperative bowel function, walking, debulking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with gynecologic cancers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- walking preoperatively not walking preoperatively
| Arm | Type | Receives |
|---|---|---|
| Walk preoperativelying | Active comparator | Other: walkingPatients 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. |
| not walking preoperatively | Active comparator | Other: walkingPatients will be operated gynecologic cancers and have American Society of Anesthesia score 1 or 2. Subjects will not walk preoperatively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with gynecological cancer ASA score 1 or 2 via laparascopy or laparatomy
Key exclusion criteria (1 listed)
- ASA score >2 orthopedic problems ileostomy or colostomy >24 hours stay in intensive care unit early postoperative complications (relaparotomy, massive blood transfusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walkingwalking and not walking | Other | Walk preoperativelying, not walking preoperatively |
Primary outcome
the time to the first passage of flatus after surgery
Time frame: 6 hours- 5 days
Doctor will detect the time with auscultation
2 secondary outcomes
the time to first defecation
Time frame: 6 hours- 7 day
time to first bowel movement
Time frame: 6 hours- 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Results publication: PubMed 27780709Gungorduk 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.
- Derived from this study: PubMed 31326951Ozdemir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking in people with Postoperative Bowel Functions, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to the first passage of flatus after surgery (time frame: 6 hours- 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553121, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.