MortalityNCT04740619
Natural Orifice Specimen Extraction in Sigmoid Volvulus
An observational study of Mortality and Morbidity, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Natural Orifice Specimen Extraction
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 20 Jan 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: sigmoid volvulus patients
Who may be able to join
- transanal for specimen extraction by elective laparoscopic sigmoid colon resection
Who cannot join
- emergency surgery
- conventional open sigmoid resection
- conventional laparoscopic sigmoid resection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ersin Arslan Training and Resource Hospital
Gaziantep
About this study
Official title: 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.
Read the 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.
- Being tested
- Natural Orifice Specimen Extraction
- Keywords
- colon, volvulus, natural orifice, laparoscopy, sigmoid
- Medical subject headings
- Intestinal Volvulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Orifice Specimen ExtractionProcedure or surgery
Natural Orifice Specimen Extraction via transanal
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality after this procedure
Measured: 1 year
morbidity
morbidity after this procedure
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Jan 2018
- Primary completion15 Jan 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ersin Arslan Education and Training Hospital
- Sponsor type
- Other government
- Collaborators
- Inonu University
- Responsible party
- Principal investigator, Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740619
- Sponsor's protocol ID
- 2020/178
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Orifice Specimen Extraction in Sigmoid Volvulus Patients
- ClinicalTrials.gov ID
- NCT04740619
- Acronym / sponsor ID
- 2020/178
- Keywords
- colon, volvulus, natural orifice, laparoscopy, sigmoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dr. Ersin Arslan Education and Training HospitalOther government
- Collaborators
- Inonu University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 5 Feb 2021 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- sigmoid volvulus patients
Key inclusion criteria (1 listed)
- transanal for specimen extraction by elective laparoscopic sigmoid colon resection
Key exclusion criteria (3 listed)
- emergency surgery
- conventional open sigmoid resection
- conventional laparoscopic sigmoid resection
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 Orifice Specimen ExtractionNatural Orifice Specimen Extraction via transanal | Procedure or surgery | – |
Primary outcome
mortality
Time frame: 1 year
mortality after this procedure
morbidity
Time frame: through study completion, an average of 1 year
morbidity after this procedure
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 5 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Mortality
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
RecruitingPhase 4
BRAVO is a Phased Outbreak-response Study in the DRC Evaluating ERVEBO® Vaccination in ~20,000 Frontline Workers During the 2026 BDV Outbreak, Step A Assesses Real-world Effectiveness, Safety, and Impact on Severe Disease and Mortality, While Generating Evidence for Future BDV Vaccination Strategies
Ebola, Bundibugyo Virus Disease (BVD)
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mortality and Morbidity, run by Dr. Ersin Arslan Education and Training Hospital 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 3 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 5 Feb 2021. 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?
mortality (time frame: 1 year). The study lists 2 primary outcomes in all. 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 5 Feb 2021.