- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03487289
Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery
October 10, 2019 updated by: Ersin Gündoğan, Inonu University
Laparoscopic right hemicolectomy (LRH) is an accepted surgical procedure for several right sided colonic pathologies.
Recently the advantages of the intracorporeal ileotransversostomy over the extracorporeal anastomosis is appearing in the literature.
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 LRH.
Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LRHs.
Study Overview
Detailed Description
compare the patient-selected NOSE method and conventional method in laparoscopic right colon cancer surgery
Study Type
Interventional
Enrollment (Actual)
52
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
-
-
-
Malatya, Turkey, 44090
- İnonu University
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- laparoscopic right hemicolectomy patients
Exclusion Criteria:
- no
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: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: natural orifice
Patients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered.
demographic data and perioperative results will be compiled
|
laparoscopic right colon surgery and patients who are removed from the natural orifice and conventional will gather
Other Names:
|
No Intervention: conventional
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS control
Time Frame: 6 years
|
Visual Analog Score for pain (1-10 score)
|
6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2013
Primary Completion (Actual)
March 25, 2019
Study Completion (Actual)
March 28, 2019
Study Registration Dates
First Submitted
February 3, 2018
First Submitted That Met QC Criteria
March 27, 2018
First Posted (Actual)
April 4, 2018
Study Record Updates
Last Update Posted (Actual)
October 14, 2019
Last Update Submitted That Met QC Criteria
October 10, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/27-5
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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