Gastrointestinal Disorder PostoperativeNCT02543853
The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function
A study testing direct trocar entry and veres needle entry in people with Gastrointestinal Disorder Postoperative, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gastrointestinal Disorder Postoperative
- What is being tested?
- direct trocar entry and veres needle entry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Oct 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Laparoscopic surgery for benign or malignant disease
Who cannot join
- Patients with gastrointestinal intervention
- Patients who had undergone previous operations
- Patients with gastrointestinal intervention dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil
Istanbul
enis ozkaya, md, enokaya1979@gmail.com
About this study
The purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions.
Read the detailed description
Women planned to have laparoscopic surgery will be randomized into two groups, in first group pneumoperitoneum will be provided by veres needle, in other group direct trocar entry will be used to provide pneumoperitoneum. After surgery gastrointesitinal functions, shoulder pain, blood loss will be compared between groups.
- Conditions
- Gastrointestinal Disorder Postoperative
- Being tested
- direct trocar entry, veres needle entry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct trocar entryOther
direct trocar entry to provide pneumoperitoneum
veres needle entryOther
veres needle entry to provide pneumoperitoneum
| Study group | Role | What they receive |
|---|---|---|
| veres needle entry arm | Active comparator | Vere needle will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared Receives: Other: veres needle entry |
| direct trocar entry arm | Active comparator | Direct trocar entry will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared Receives: Other: direct trocar entry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel sound (first bowel sound)
time from surgery to first bowel sound as hours
Measured: Postoperative first 72 hours
Secondary outcomes (1)
Gas discharge
time from surgery to first bowel sound as hours
Measured: Postoperative first 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Disorder PostoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enis ozkaya, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543853
- Sponsor's protocol ID
- 990902
- Status last verified
- Sep 2015
- First submitted
- 24 May 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Compeau C, McLeod NT, Ternamian A. Laparoscopic entry: a review of Canadian general surgical practice. Can J Surg. 2011 Oct;54(5):315-20. doi: 10.1503/cjs.011210.
PubMed 21774882Daskalakis M, Scheffel O, Weiner RA. High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Obes Facts. 2009;2 Suppl 1(Suppl 1):37-40. doi: 10.1159/000198252. Epub 2009 Mar 18.
PubMed 20124777Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.
PubMed 22336819
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function
- ClinicalTrials.gov ID
- NCT02543853
- Acronym / sponsor ID
- 990902
- Conditions
- Gastrointestinal Disorder Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 7 Sep 2015 (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 purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions.
Detailed description
Women planned to have laparoscopic surgery will be randomized into two groups, in first group pneumoperitoneum will be provided by veres needle, in other group direct trocar entry will be used to provide pneumoperitoneum. After surgery gastrointesitinal functions, shoulder pain, blood loss will be compared between groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| veres needle entry arm | Active comparator | Other: veres needle entryVere needle will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared |
| direct trocar entry arm | Active comparator | Other: direct trocar entryDirect trocar entry will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Laparoscopic surgery for benign or malignant disease
Key exclusion criteria (3 listed)
- Patients with gastrointestinal intervention
- Patients who had undergone previous operations
- Patients with gastrointestinal intervention dysfunction
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 |
|---|---|---|
| direct trocar entrydirect trocar entry to provide pneumoperitoneum | Other | direct trocar entry arm |
| veres needle entryveres needle entry to provide pneumoperitoneum | Other | veres needle entry arm |
Primary outcome
Bowel sound (first bowel sound)
Time frame: Postoperative first 72 hours
time from surgery to first bowel sound as hours
1 secondary outcome
Gas discharge
Time frame: Postoperative first 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Background: PubMed 21774882Compeau C, McLeod NT, Ternamian A. Laparoscopic entry: a review of Canadian general surgical practice. Can J Surg. 2011 Oct;54(5):315-20. doi: 10.1503/cjs.011210.
- Background: PubMed 20124777Daskalakis M, Scheffel O, Weiner RA. High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Obes Facts. 2009;2 Suppl 1(Suppl 1):37-40. doi: 10.1159/000198252. Epub 2009 Mar 18.
- Results publication: PubMed 22336819Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct trocar entry and veres needle entry in people with Gastrointestinal Disorder Postoperative, run by Zeynep Kamil Maternity and Pediatric 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 3 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 7 Sep 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?
Contact Enis Ozkaya, md (905054742459, enozkaya1979@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel sound (first bowel sound) (time frame: Postoperative first 72 hours). 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 NCT02543853, which also lists 3 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 7 Sep 2015.