AppendicitisPhase 2NCT01283815
Laparoscopic Management of Periappendicular Abscess
A Phase 2 study testing Laparoscopic appendectomy and Conservative management with percutaneous drainage in people with Appendicitis and Abdominal Abscess, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
According to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. Large abscesses require percutaneous drainage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Appendicitis, Abdominal Abscess
- What is being tested?
- Laparoscopic appendectomy and Conservative management with percutaneous drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Aug 2014
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periappendicular abscess at least 2 cm in size
Who cannot join
- Missing written informed consent
- Antimicrobial therapy lasted over 24 hours before randomization
- Attempt of drainage before randomization
- Age over 80 years or under 18 years old
- Pregnancy
- Allergy to either Cefuroxime or Metronidazole
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- Severe chronic disease, that substantially increases the risk for operative mortality
- Previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions
- Carrier of a resistant bacterial strain
- Being institutionalized or hospitalized for at least 2 weeks before randomization
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Meilahti Hospital
Helsinki, 00029
About this study
Official title: Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial
According to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not possible because of anatomical position of the abscess and surgical treatment is needed. The purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the first-line treatment in patients with periappendicular abscess.
The hypothesis of the study is that laparoscopic management of periappendicular abscess is suitable for the first-line treatment and it does not increase time of hospitalization or complication rate compared with conservative management.
- Conditions
- Appendicitis, Abdominal Abscess
- Being tested
- Laparoscopic appendectomy, Conservative management with percutaneous drainage
- Keywords
- Laparoscopy, Drainage, Appendectomy
- Medical subject headings
- Appendicitis, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomyProcedure or surgery
Laparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group (intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day).
Conservative management with percutaneous drainageProcedure or surgery
Patients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed.
| Study group | Role | What they receive |
|---|---|---|
| Conservative management | Active comparator | Patients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed. Receives: Procedure: Conservative management with percutaneous drainage |
| Laparoscopic appendectomy | Experimental | Laparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group Receives: Procedure: Laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of hospitalization within the first 60 days after randomization
Measured: Day 60 after randomization
Secondary outcomes (5)
Need of additional interventions
Interventions include percutaneous drainage and operations
Measured: Within the first 60 days after randomization
Residual abscess
Measured: On day 7 after randomization
Attempted procedure not successfully performed
In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible.
Measured: During the first 24 hours after randomization
The number of complications
Any complication occurring within 60 days from randomization. Both medical and surgical complications are included.
Measured: Within 60 days from randomization
Number recurrent abscesses
Measured: Within 60 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panu Mentula, Helsinki University Central Hospital
- Investigators
- Panu Mentula, M.D. Ph.D., Principal investigator, Department of Gastrointestinal Surgery, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283815
- Sponsor's protocol ID
- HUSOper193
- Status last verified
- Sep 2014
- First submitted
- 20 Jan 2011
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01283815
- Acronym / sponsor ID
- HUSOper193
- Conditions
- Appendicitis, Abdominal Abscess
- Keywords
- Laparoscopy, Drainage, Appendectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Jan 2011 (estimated)
- 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.
According to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not possible because of anatomical position of the abscess and surgical treatment is needed. The purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the first-line treatment in patients with periappendicular abscess.
The hypothesis of the study is that laparoscopic management of periappendicular abscess is suitable for the first-line treatment and it does not increase time of hospitalization or complication rate compared with conservative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative management | Active comparator | Procedure: Conservative management with percutaneous drainagePatients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed. |
| Laparoscopic appendectomy | Experimental | Procedure: Laparoscopic appendectomyLaparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Periappendicular abscess at least 2 cm in size
Key exclusion criteria (10 listed)
- Missing written informed consent
- Antimicrobial therapy lasted over 24 hours before randomization
- Attempt of drainage before randomization
- Age over 80 years or under 18 years old
- Pregnancy
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 |
|---|---|---|
| Laparoscopic appendectomyLaparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group (intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day). | Procedure or surgery | Laparoscopic appendectomy |
| Conservative management with percutaneous drainagePatients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed. | Procedure or surgery | Conservative management |
Primary outcome
Time of hospitalization within the first 60 days after randomization
Time frame: Day 60 after randomization
5 secondary outcomes
Need of additional interventions
Time frame: Within the first 60 days after randomization
Residual abscess
Time frame: On day 7 after randomization
Attempted procedure not successfully performed
Time frame: During the first 24 hours after randomization
The number of complications
Time frame: Within 60 days from randomization
Number recurrent abscesses
Time frame: Within 60 days after randomization
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 23 Sep 2014.
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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.
Panu Mentula, M.D. Ph.D. principal investigator
Department of Gastrointestinal Surgery, Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic appendectomy and Conservative management with percutaneous drainage in people with Appendicitis and Abdominal Abscess, run by Helsinki University Central Hospital at 1 site in Finland.
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 10 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 23 Sep 2014. 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 Finland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time of hospitalization within the first 60 days after randomization (time frame: Day 60 after randomization). 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 23 Sep 2014.