Postoperative Bowel SoundsNCT01917396
Influence of Preoperative Enema Application on Return of Gastrointestinal Function After Elective Cesarean Section: A Randomized Controlled Study
A study testing Fleet enema in people with Postoperative Bowel Sounds and Bowel Gass Passage, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).
Trial summary
The researchers investigate that use of preoperative enema to the effect postoperative bowel gas passage. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Bowel Sounds, Bowel Gass Passage
- What is being tested?
- Fleet enema
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Oct 2014
- Phase
- Expanded access
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- elective cesarean
- no history of previous abdominal operation(except cs)
Who cannot join
- Emergency cesarean delivery
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Education and Research Hospital,
Izmir, Yenisehir, 35120
About this study
The researchers investigate that use of preoperative enema to the effect postoperative bowel gas passage.
- Conditions
- Postoperative Bowel Sounds, Bowel Gass Passage
- Being tested
- Fleet enema
- Keywords
- caesarean, bowel, gass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fleet enemaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Bowel SoundsStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Investigators
- İbrahim Egemen Ertaş, M.D., Principal investigator, Tepecik Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917396
- Sponsor's protocol ID
- Aşıcıoğlu 04
- Status last verified
- Jan 2015
- First submitted
- 4 Aug 2013
- Last updated
- 20 Feb 2015
- Results posted
- No
Publications
Lurie S, Baider C, Glickman H, Golan A, Sadan O. Are enemas given before cesarean section useful? A prospective randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):27-9. doi: 10.1016/j.ejogrb.2012.03.034. Epub 2012 Apr 17.
PubMed 22516178
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preoperative Enema Application on Return of Gastrointestinal Function After Elective Cesarean Section: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01917396
- Acronym / sponsor ID
- Aşıcıoğlu 04
- Conditions
- Postoperative Bowel Sounds, Bowel Gass Passage
- Keywords
- caesarean, bowel, gass
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- 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.
The researchers investigate that use of preoperative enema to the effect postoperative bowel gas passage.
Study design
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- elective cesarean
- no history of previous abdominal operation(except cs)
Key exclusion criteria (2 listed)
- Emergency cesarean delivery
- Refusal to participate.
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 |
|---|---|---|
| Fleet enema | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Results publication: PubMed 22516178Lurie S, Baider C, Glickman H, Golan A, Sadan O. Are enemas given before cesarean section useful? A prospective randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):27-9. doi: 10.1016/j.ejogrb.2012.03.034. Epub 2012 Apr 17.
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RecruitingObservational study
The Value of Bowel Sounds in Evaluating Postoperative Intestinal Function Recovery in Colorectal Cancer Patients
Bowel Sounds, Colorectal Cancer
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.
İbrahim Egemen Ertaş, M.D. principal investigator
Tepecik Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fleet enema in people with Postoperative Bowel Sounds and Bowel Gass Passage, run by Istanbul Bakirkoy Maternity and Children Diseases 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 2015. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01917396, which also lists 1 linked publication.
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 20 Feb 2015.