- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04740619
Natural Orifice Specimen Extraction in Sigmoid Volvulus
February 4, 2021 updated by: Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
Natural Orifice Specimen Extraction in Sigmoid Volvulus Patients
Sigmoid resection can be performed using conventional and laparoscopic methods.
There are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus.
Here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Sigmoid resection can be performed using conventional and laparoscopic methods.
There are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus.
Here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus.
The documents of patients who were operated on for sigmoid volvulus between 2018 and 2019 were retrospectively reviewed.
Patients who had been used transanal for specimen extraction by elective laparoscopic sigmoid colon resection were included in the study.
Patients' gender, age, comorbidity, operation time, operative difficulties, complications, length of stay, and mortality findings were analyzed.
Laparoscopic sigmoid resection and transanal specimen removal were performed in eight patients.
Specimen extraction surgery from the natural hole is increasingly preferred.
the investigators think that natural hole surgery can be performed more easily and reliably in sigmoid volvulus due to the large diameter of the colon.
Study Type
Observational
Enrollment (Actual)
8
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
-
-
-
Gaziantep, Turkey
- Dr. Ersin Arslan Training and Resource Hospital
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
sigmoid volvulus patients
Description
Inclusion Criteria:
- transanal for specimen extraction by elective laparoscopic sigmoid colon resection
Exclusion Criteria:
- emergency surgery
- conventional open sigmoid resection
- conventional laparoscopic sigmoid resection
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: 1 year
|
mortality after this procedure
|
1 year
|
morbidity
Time Frame: through study completion, an average of 1 year
|
morbidity after this procedure
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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, 2018
Primary Completion (Actual)
January 15, 2020
Study Completion (Actual)
January 20, 2021
Study Registration Dates
First Submitted
February 1, 2021
First Submitted That Met QC Criteria
February 4, 2021
First Posted (Actual)
February 5, 2021
Study Record Updates
Last Update Posted (Actual)
February 5, 2021
Last Update Submitted That Met QC Criteria
February 4, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/178
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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