OutcomeNCT04746326
Treatment in Right Colon Diverticulitis Patients
A study testing Failure conservative treatment, Surgery and Conservative treatment in people with Outcome, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outcome
- What is being tested?
- Failure conservative treatment, Surgery and Conservative treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 20 Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- diagnosed with right colon diverticulitis
Who cannot join
- Left colon diverticulitis
- Right colon diverticulitis detected incidentally
- lacking data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Training and Research Hospital
Izmir, 35180
About this study
Official title: Operative and Conservative Treatment in Right Colon Diverticulitis Patients
The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Unlike the left, right colon diverticulitis has low complications and can be treated conservatively. The differential diagnosis of right colon diverticulitis should be kept in mind in order to prevent unnecessary surgeries. Surgical treatment is inevitable in cases such as recurrent diverticulitis, generalized peritonitis, and suspected malignancy.
Read the detailed description
The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Here, we aimed to discuss the results of conservative and surgical treatment for right colon diverticulitis in the light of the literature. 150 patients treated for colon diverticulitis between 2015-2020 were retrospectively screened. Right colon diverticulitis detected incidentally, missing data, and left colon diverticulitis were excluded from the study. Data of a total of 26 patients were accessed. Unlike the left, right colon diverticulitis has low complications and can be treated conservatively. The differential diagnosis of right colon diverticulitis should be kept in mind in order to prevent unnecessary surgeries. Surgical treatment is inevitable in cases such as recurrent diverticulitis, generalized peritonitis, and suspected malignancy
- Conditions
- Outcome
- Being tested
- Failure conservative treatment, Surgery, Conservative treatment
- Keywords
- diverticulum, surgery, appendicitis, sigmoid volvulus, caecum, diverticulitis
- Medical subject headings
- Diverticulum, Appendicitis, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Failure conservative treatmentProcedure or surgery
Surgery was performed in patients who failed conservative treatment.
SurgeryProcedure or surgery
Surgery was performed in patients who had generalized peritonitis and perforation.
Conservative treatmentOther
Conservative treatment was performed in patients who had no generalized peritonitis and perforation.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Other | Conservative treatment stopping oral intake, intravenous antibiotic therapy. Receives: Other: Conservative treatment |
| Operative treatment | Other | Operative procedure Right hemicolectomy Wedge resection of cecum Diverticulectomy + appendectomy Diverticulectomy Appendectomy + drainage Receives: Procedure: Failure conservative treatment; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with mortality
mortality
Measured: up to 24 weeks
Number of Participants with wound infection
wound infection
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- 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 OutcomeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Conservative treatment, Operative treatment
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Demirli Atici, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746326
- Sponsor's protocol ID
- 2020 / 14-6
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 9 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 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative and Conservative Treatment in Right Colon Diverticulitis Patients
- ClinicalTrials.gov ID
- NCT04746326
- Acronym / sponsor ID
- 2020 / 14-6
- Conditions
- Outcome
- Keywords
- diverticulum, surgery, appendicitis, sigmoid volvulus, caecum, diverticulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 9 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.
The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Unlike the left, right colon diverticulitis has low complications and can be treated conservatively. The differential diagnosis of right colon diverticulitis should be kept in mind in order to prevent unnecessary surgeries. Surgical treatment is inevitable in cases such as recurrent diverticulitis, generalized peritonitis, and suspected malignancy.
Detailed description
The right colon diverticula, unlike those in the left colon, contain all layers of the colon and is called the true diverticulum. Perforation is observed less frequently due to its full thickness. Conservative treatment can be applied unless complications such as abscess formation and free perforation occur. Here, we aimed to discuss the results of conservative and surgical treatment for right colon diverticulitis in the light of the literature. 150 patients treated for colon diverticulitis between 2015-2020 were retrospectively screened. Right colon diverticulitis detected incidentally, missing data, and left colon diverticulitis were excluded from the study. Data of a total of 26 patients were accessed. Unlike the left, right colon diverticulitis has low complications and can be treated conservatively. The differential diagnosis of right colon diverticulitis should be kept in mind in order to prevent unnecessary surgeries. Surgical treatment is inevitable in cases such as recurrent diverticulitis, generalized peritonitis, and suspected malignancy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Conservative treatment, Operative treatment
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Other | Other: Conservative treatmentConservative treatment stopping oral intake, intravenous antibiotic therapy. |
| Operative treatment | Other | Procedure: Failure conservative treatment, Procedure: SurgeryOperative procedure Right hemicolectomy Wedge resection of cecum Diverticulectomy + appendectomy Diverticulectomy Appendectomy + drainage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with right colon diverticulitis
Key exclusion criteria (3 listed)
- Left colon diverticulitis
- Right colon diverticulitis detected incidentally
- lacking data
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 |
|---|---|---|
| Failure conservative treatmentSurgery was performed in patients who failed conservative treatment. | Procedure or surgery | Operative treatment |
| SurgerySurgery was performed in patients who had generalized peritonitis and perforation. | Procedure or surgery | Operative treatment |
| Conservative treatmentConservative treatment was performed in patients who had no generalized peritonitis and perforation. | Other | Conservative treatment |
Primary outcome
Number of Participants with mortality
Time frame: up to 24 weeks
mortality
Number of Participants with wound infection
Time frame: up to 24 weeks
wound infection
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 9 Feb 2021.
- Individual participant dataSharing planned: No
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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?
A study testing Failure conservative treatment, Surgery and Conservative treatment in people with Outcome, run by Tepecik Training and Research 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 9 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?
Number of Participants with mortality (time frame: up to 24 weeks). 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 9 Feb 2021.