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Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery

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ClinicalTrials.gov Identifier: NCT03487289
Recruitment Status : Completed
First Posted : April 4, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ersin Gündoğan, Inonu University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgical Incision Procedure: natural orifice Not Applicable

Detailed Description:
compare the patient-selected NOSE method and conventional method in laparoscopic right colon cancer surgery
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 28, 2019
Arms and Interventions
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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
 Procedure: natural orifice
laparoscopic right colon surgery and patients who are removed from the natural orifice and conventional will gather
Other Name: conventional
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)


Outcome Measures
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Primary Outcome Measures :
  1. VAS control [ Time Frame: 6 years ]
    Visual Analog Score for pain (1-10 score)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laparoscopic right hemicolectomy patients

Exclusion Criteria:

  • no
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487289


Locations
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Turkey
Inonu University
Malatya, Turkey, 44090
Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: Ersin Gündoğan Inonu Unıversity- general surgery
More Information
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Responsible Party: Ersin Gündoğan, operator doctor, Inonu University
ClinicalTrials.gov Identifier: NCT03487289    
Other Study ID Numbers: 2017/27-5
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries