Back to resultsComparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
Primary Purpose
Surgical Incision
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
natural orifice
Sponsored by
About this trial
This is an interventional health services research trial for Surgical Incision
Eligibility Criteria
Inclusion Criteria:
- laparoscopic total colectomy patients
Exclusion Criteria:
- no
Sites / Locations
- Inonu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
natural orifice
conventional
Arm Description
Patients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered. demographic data and perioperative results will be compiled
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)
Outcomes
Primary Outcome Measures
Visual Analog Score
Visual Analog Score for pain (1-10 score)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03499769
Brief Title
Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
Official Title
Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 25, 2017 (Actual)
Study Completion Date
December 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 . 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
natural orifice
Arm Type
Experimental
Arm Description
Patients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered. demographic data and perioperative results will be compiled
Arm Title
conventional
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
natural orifice
Other Intervention Name(s)
conventional
Intervention Description
laparoscopic total colon surgery and patients who are removed from the natural orifice and conventional will gather
Primary Outcome Measure Information:
Title
Visual Analog Score
Description
Visual Analog Score for pain (1-10 score)
Time Frame
240 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
laparoscopic total colectomy patients
Exclusion Criteria:
no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ersin Gündoğan
Organizational Affiliation
Inonu Unıversity- general surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44090
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
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