Surgical IncisionNCT03499769
Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
A study testing natural orifice in people with Surgical Incision, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic pathologies. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Incision
- What is being tested?
- natural orifice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2013to 28 Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laparoscopic total colectomy patients
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic pathologies. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LTC. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LTCs.
Read the detailed description
compare the patient-selected NOSE method and conventional method in laparoscopic total colon surgery
- Conditions
- Surgical Incision
- Being tested
- natural orifice
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural orificeProcedure or surgery
Also called conventional
laparoscopic total colon surgery and patients who are removed from the natural orifice and conventional will gather
| Study group | Role | What they receive |
|---|---|---|
| natural orifice | Experimental | Patients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered. demographic data and perioperative results will be compiled Receives: Procedure: natural orifice |
| conventional | No intervention | patients who underwent laparoscopic surgery and removed specimen with conventional will be gathered. demographic data and perioperative results will be compiled. (conventional extraction is suprapubic or median incision) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score
Visual Analog Score for pain (1-10 score)
Measured: 240 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Jan 2013
- Primary completion25 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Gündoğan, Inonu University
- Investigators
- Ersin Gündoğan, Principal investigator, Inonu Unıversity- general surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499769
- Sponsor's protocol ID
- 2018/3-3
- Status last verified
- Feb 2018
- First submitted
- 27 Mar 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
- ClinicalTrials.gov ID
- NCT03499769
- Acronym / sponsor ID
- 2018/3-3
- Conditions
- Surgical Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 17 Apr 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.
Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic pathologies. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LTC. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LTCs.
Detailed description
compare the patient-selected NOSE method and conventional method in laparoscopic total colon surgery
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| natural orifice | Experimental | Procedure: natural orificePatients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered. demographic data and perioperative results will be compiled |
| conventional | No intervention | –patients who underwent laparoscopic surgery and removed specimen with conventional will be gathered. demographic data and perioperative results will be compiled. (conventional extraction is suprapubic or median incision) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- laparoscopic total colectomy patients
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| natural orificeAlso: conventionallaparoscopic total colon surgery and patients who are removed from the natural orifice and conventional will gather | Procedure or surgery | natural orifice |
Primary outcome
Visual Analog Score
Time frame: 240 days
Visual Analog Score for pain (1-10 score)
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 20 Jul 2018.
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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.
Ersin Gündoğan principal investigator
Inonu Unıversity- general surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing natural orifice in people with Surgical Incision, run by Inonu University 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 20 Jul 2018. 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?
Visual Analog Score (time frame: 240 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2018.