AppendicitisISAACNCT02688244
Irrigation Versus Suction in Complicated Acute Appendicitis
A study testing Irrigation and No irrigation in people with Appendicitis and Abdominal Abscess, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in complicated acute appendicitis performing irrigation of the abdominal cavity or only suction without lavage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis, Abdominal Abscess, Acute Disease
- What is being tested?
- Irrigation and No irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2015to Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with complicated acute appendiccitis
- Laparoscopic approach
Who cannot join
- Open approach
- Medical or psychiatric condition of the patient that compromises the informed consent authorisation
- Non complicated acute appendicitis
- Underage patients (<18)
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de La Arrixaca
Murcia, Murcia, 30120
Jesus Abrisqueta, Ph D, +34 968369677
Maria Teresa Soriano, MD
About this study
Official title: Randomized Trial Comparing Irrigation Versus Suction in Laparoscopic Appendectomy for Complicated Acute Appendicitis in Adults
This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in complicated acute appendicitis performing irrigation of the abdominal cavity or only suction without lavage.
Read the detailed description
Despite the available literature for and against the irrigation of the abdominal cavity in complicated acute appendicitis, in the current practice of this and other centres, the irrigation and no irrigation is made equally depending on the surgeon who performs the intervention.
Those who systematically irrigate the abdominal cavity in laparoscopic appendectomies do it as an inherited act from open surgery and those who systematically do not irrigate the abdominal cavity base their choice in theories such as abscess migration due to the irrigation and difficulty of the suction of all the irrigated fluid, spreading, therefore, the infection.
The intention of the investigators is to provide evidence about this technique in order to either systematize peritoneal irrigation in laparoscopic appendectomy for complicated appendicitis or avoid an unnecessary gesture, if it were established so.
This will be a prospective, randomized clinical trial involving patients who present to the hospital with complicated acute appendicitis. Power calculation was based on abscess rate in the investigators' hospital calculated retrospectively (15%) Subjects will be those patients above 18 y.o. who are found to have complicated acute appendicitis (defined as perforated appendicitis before or during surgery, gangrenous appendicitis and/or purulent peritonitis).
The final decision to include a patient in the study will made after complication has been visually confirmed during surgery. The randomization assignment will be made known at the initiation of the operation, and confirmation of complication will confirm the patient will utilize the next randomization slot.
The irrigation group will have suction irrigator set up with a 1 liter bag of normal saline. The surgeon must use at least 300 ml of this bag but may use as much as they choose.
The no irrigation group will have the suction irrigator set up without the saline attachment. This will leave them with the capacity for suction only. Since several suction devices exist, this will assure the same type of suction for both groups.
After the operation, both groups will be managed in the same manner. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. If the participants stay until the 5th post-operative day, a white blood cell count will be checked, which if it is normal, they will be discharged to home without antibiotics.
- Conditions
- Appendicitis, Abdominal Abscess, Acute Disease, Cecal Diseases, Infection
- Being tested
- Irrigation, No irrigation
- Keywords
- complicated appendicitis, laparoscopic appendectomy, irrigation, suction, abdominal abscess
- Medical subject headings
- Appendicitis, Abdominal Abscess, Acute Disease, Cecal Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrrigationProcedure or surgery
Also called Washout
Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator
No irrigationProcedure or surgery
Also called Suction
Suction only, using suction device
| Study group | Role | What they receive |
|---|---|---|
| Irrigation | Active comparator | Irrigation of the area with at least 300ml normal saline using the power suction/irrigator Receives: Procedure: Irrigation |
| No irrigation | Active comparator | Only suction with the power suction/irrigator without saline attached Receives: Procedure: No irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative abscess
Number of post-operative abscesses in each arm
Measured: 1 month
Location of post-operative abscess
Number of abscesses in every quadrant of the abdomen
Measured: One month
Treatment of post-operative abscess
Number of post-operative abscesses treated with a radiological drain
Measured: One month
Secondary outcomes (4)
Operating time
Length of surgery, in minutes.
Measured: 1 day
Hospital stay (Time until discharge)
Time until discharge, in days.
Measured: 2 weeks
Postoperative pain (Visual analogic scale)
Visual analogic scale, from 1 to 10
Measured: 6 days
Postoperatory fever
Body temperature in Celsius degrees
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Abrisqueta Carrion, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688244
- Sponsor's protocol ID
- AAC-2015-HCUVA
- Acronym
- ISAAC
- Status last verified
- Feb 2016
- First submitted
- 1 Dec 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Irrigation Versus Suction in Laparoscopic Appendectomy for Complicated Acute Appendicitis in Adults
- ClinicalTrials.gov ID
- NCT02688244
- Acronym / sponsor ID
- ISAAC / AAC-2015-HCUVA
- Conditions
- Appendicitis, Abdominal Abscess, Acute Disease, Cecal Diseases, Infection
- Keywords
- complicated appendicitis, laparoscopic appendectomy, irrigation, suction, abdominal abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 23 Feb 2016 (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.
This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in complicated acute appendicitis performing irrigation of the abdominal cavity or only suction without lavage.
Detailed description
Despite the available literature for and against the irrigation of the abdominal cavity in complicated acute appendicitis, in the current practice of this and other centres, the irrigation and no irrigation is made equally depending on the surgeon who performs the intervention.
Those who systematically irrigate the abdominal cavity in laparoscopic appendectomies do it as an inherited act from open surgery and those who systematically do not irrigate the abdominal cavity base their choice in theories such as abscess migration due to the irrigation and difficulty of the suction of all the irrigated fluid, spreading, therefore, the infection.
The intention of the investigators is to provide evidence about this technique in order to either systematize peritoneal irrigation in laparoscopic appendectomy for complicated appendicitis or avoid an unnecessary gesture, if it were established so.
This will be a prospective, randomized clinical trial involving patients who present to the hospital with complicated acute appendicitis. Power calculation was based on abscess rate in the investigators' hospital calculated retrospectively (15%) Subjects will be those patients above 18 y.o. who are found to have complicated acute appendicitis (defined as perforated appendicitis before or during surgery, gangrenous appendicitis and/or purulent peritonitis).
The final decision to include a patient in the study will made after complication has been visually confirmed during surgery. The randomization assignment will be made known at the initiation of the operation, and confirmation of complication will confirm the patient will utilize the next randomization slot.
The irrigation group will have suction irrigator set up with a 1 liter bag of normal saline. The surgeon must use at least 300 ml of this bag but may use as much as they choose.
The no irrigation group will have the suction irrigator set up without the saline attachment. This will leave them with the capacity for suction only. Since several suction devices exist, this will assure the same type of suction for both groups.
After the operation, both groups will be managed in the same manner. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. If the participants stay until the 5th post-operative day, a white blood cell count will be checked, which if it is normal, they will be discharged to home without antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation | Active comparator | Procedure: IrrigationIrrigation of the area with at least 300ml normal saline using the power suction/irrigator |
| No irrigation | Active comparator | Procedure: No irrigationOnly suction with the power suction/irrigator without saline attached |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with complicated acute appendiccitis
- Laparoscopic approach
Key exclusion criteria (5 listed)
- Open approach
- Medical or psychiatric condition of the patient that compromises the informed consent authorisation
- Non complicated acute appendicitis
- Underage patients (<18)
- Refusal to participate in the study.
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 |
|---|---|---|
| IrrigationAlso: WashoutIrrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator | Procedure or surgery | Irrigation |
| No irrigationAlso: SuctionSuction only, using suction device | Procedure or surgery | No irrigation |
Primary outcome
Incidence of post-operative abscess
Time frame: 1 month
Number of post-operative abscesses in each arm
Location of post-operative abscess
Time frame: One month
Number of abscesses in every quadrant of the abdomen
Treatment of post-operative abscess
Time frame: One month
Number of post-operative abscesses treated with a radiological drain
4 secondary outcomes
Operating time
Time frame: 1 day
Hospital stay (Time until discharge)
Time frame: 2 weeks
Postoperative pain (Visual analogic scale)
Time frame: 6 days
Postoperatory fever
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation and No irrigation in people with Appendicitis and Abdominal Abscess, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 2016. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-operative abscess (time frame: 1 month). The study lists 3 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 23 Feb 2016.