AppendicitisPECASNCT02726152
Polymer Clips Versus Endoloops for Closure of the Appendiceal Stump During Emergency Laparoscopic Appendicectomy
A study testing Polymer clips for closure of the appendiceal stump and Endoloops for closure of the appendiceal stump in people with Appendicitis, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial summary
The investigators propose a study to compare two methods of closing the stump of the appendix during an emergency excision of the appendix using a keyhole approach. One similarly designed study has been undertaken in another institution but there were not enough patients recruited to the study to allow meaningful… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appendicitis
- What is being tested?
- Polymer clips for closure of the appendiceal stump and Endoloops for closure of the appendiceal stump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Sep 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with clinical suspicion of acute appendicitis who are to do undergo diagnostic laparoscopy +/- appendicectomy
- Over the age of 16 years
- Able to give informed consent for inclusion in the study
Who cannot join
- Intraoperative decision to convert to open appendicectomy
- Primary open appendicectomy
- Under 16 years old
- Unable to give informed consent for participation in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ninewells Hospital
Dundee, Angus, DD1 9SY
Michael Wilson, 07809720090, msjwilson@me.com
Pradeep Patil, 01382660111 ext. 5409, pradeeppatil@nhs.net
About this study
Official title: Randomised Control Trial: Polymer Clips Versus Endoloops for Closure of the Appendiceal Stump During Emergency Laparoscopic Appendicectomy (The PECAS Trial)
The investigators propose a study to compare two methods of closing the stump of the appendix during an emergency excision of the appendix using a keyhole approach. One similarly designed study has been undertaken in another institution but there were not enough patients recruited to the study to allow meaningful conclusions to be drawn.
Any patient over the age of 16 years whom the investigators suspect to have acute appendicitis will be considered for recruitment to the study. During their exploratory keyhole surgery, if the surgical team feels that excision of the appendix is indicated then the patient will be randomly allocated to either polymer clips or endoloops to the part of the procedure where the stump (base) of the appendix is closed.
The main aim is to determine if polymer clips shorten the duration of the operation. The investigators will also determine if there is a difference between the rates of complications, the time spent in hospital and the number of times the participants had to be readmitted to hospital within 30 days.
Read the detailed description
The investigators propose to perform a randomised control trial within NHS Tayside comparing two forms of appendiceal stump closure in emergency laparoscopic appendicectomy. A previous RCT examining this topic could have been better designed, with a small trial population and the absence of a power calculation.
All patients over 16 years old undergoing diagnostic laparoscopy for acute appendicitis will be eligible for recruitment to the trial and be consented prior to theatre. Intra-operatively, when the decision to perform an appendicectomy is taken, participants will be randomised to either the application of polymer (Locaclip) clips or endoloops to the appendiceal stump for closure during laparoscopic appendicectomy. The primary outcome will be operative time, while secondary outcomes include post-operative complications length of hospital stay and re-admission rate within 30 days. Participants will require no formal follow-up, either in the out-patient clinic or telephone consultations.
Statistical analysis will predominantly use Fisher's exact test to determine any statistically significant differences between each intervention arm, whilst group homogeneity will be analysed for other important patient parameters.
The investigators hypothesise that the operative time will be less in the polymer group compared to the endoloop group, while no significant difference will be seen in post-operative complications or other secondary outcomes between the two cohorts. The results of this RCT will add to the evidence-base for the use of polymer clips in appendiceal stump closure and potentially support its use for routine clinical practice. It is anticipated that it will take one year to recruit participants for the study and a further 30 days to complete follow up for the last participant recruited.
- Conditions
- Appendicitis
- Being tested
- Polymer clips for closure of the appendiceal stump, Endoloops for closure of the appendiceal stump
- Keywords
- Diagnostic laparoscopy, Acute appendicitis, Appendiceal stump
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymer clips for closure of the appendiceal stumpProcedure or surgery
Application of polymer clips to the appendiceal stump
Endoloops for closure of the appendiceal stumpProcedure or surgery
Application of endoloops to the appendiceal stump
| Study group | Role | What they receive |
|---|---|---|
| Polymer clips | Experimental | Patients will be randomised to polymer clips for closure of the appendiceal stump Receives: Procedure: Polymer clips for closure of the appendiceal stump |
| Endoloops | Active comparator | Patients will be randomised to endoloops for closure of the appendiceal stump Receives: Procedure: Endoloops for closure of the appendiceal stump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Is there difference in the overall operating time between the two cohorts
Measured: Intraoperative
Secondary outcomes (3)
Length of hospital stay (postoperative)
Is there a significant difference in the length of postoperative stay between the two cohorts
Measured: Up to 14 days
Complications
Is there a difference in the rate of intraoperative and postoperative complications
Measured: 30 days
Readmissions to hospital within 30 days of surgery
Is there a difference in the thirty day readmission rates between the two cohorts
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michael Wilson, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726152
- Sponsor's protocol ID
- 2015SA03
- Acronym
- PECAS
- Status last verified
- Apr 2016
- First submitted
- 18 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial: Polymer Clips Versus Endoloops for Closure of the Appendiceal Stump During Emergency Laparoscopic Appendicectomy (The PECAS Trial)
- ClinicalTrials.gov ID
- NCT02726152
- Acronym / sponsor ID
- PECAS / 2015SA03
- Conditions
- Appendicitis
- Keywords
- Diagnostic laparoscopy, Acute appendicitis, Appendiceal stump
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Health Service, United KingdomOther government
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 1 Apr 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.
The investigators propose a study to compare two methods of closing the stump of the appendix during an emergency excision of the appendix using a keyhole approach. One similarly designed study has been undertaken in another institution but there were not enough patients recruited to the study to allow meaningful conclusions to be drawn.
Any patient over the age of 16 years whom the investigators suspect to have acute appendicitis will be considered for recruitment to the study. During their exploratory keyhole surgery, if the surgical team feels that excision of the appendix is indicated then the patient will be randomly allocated to either polymer clips or endoloops to the part of the procedure where the stump (base) of the appendix is closed.
The main aim is to determine if polymer clips shorten the duration of the operation. The investigators will also determine if there is a difference between the rates of complications, the time spent in hospital and the number of times the participants had to be readmitted to hospital within 30 days.
Detailed description
The investigators propose to perform a randomised control trial within NHS Tayside comparing two forms of appendiceal stump closure in emergency laparoscopic appendicectomy. A previous RCT examining this topic could have been better designed, with a small trial population and the absence of a power calculation.
All patients over 16 years old undergoing diagnostic laparoscopy for acute appendicitis will be eligible for recruitment to the trial and be consented prior to theatre. Intra-operatively, when the decision to perform an appendicectomy is taken, participants will be randomised to either the application of polymer (Locaclip) clips or endoloops to the appendiceal stump for closure during laparoscopic appendicectomy. The primary outcome will be operative time, while secondary outcomes include post-operative complications length of hospital stay and re-admission rate within 30 days. Participants will require no formal follow-up, either in the out-patient clinic or telephone consultations.
Statistical analysis will predominantly use Fisher's exact test to determine any statistically significant differences between each intervention arm, whilst group homogeneity will be analysed for other important patient parameters.
The investigators hypothesise that the operative time will be less in the polymer group compared to the endoloop group, while no significant difference will be seen in post-operative complications or other secondary outcomes between the two cohorts. The results of this RCT will add to the evidence-base for the use of polymer clips in appendiceal stump closure and potentially support its use for routine clinical practice. It is anticipated that it will take one year to recruit participants for the study and a further 30 days to complete follow up for the last participant recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polymer clips | Experimental | Procedure: Polymer clips for closure of the appendiceal stumpPatients will be randomised to polymer clips for closure of the appendiceal stump |
| Endoloops | Active comparator | Procedure: Endoloops for closure of the appendiceal stumpPatients will be randomised to endoloops for closure of the appendiceal stump |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinical suspicion of acute appendicitis who are to do undergo diagnostic laparoscopy +/- appendicectomy
- Over the age of 16 years
- Able to give informed consent for inclusion in the study
Key exclusion criteria (4 listed)
- Intraoperative decision to convert to open appendicectomy
- Primary open appendicectomy
- Under 16 years old
- Unable to give informed consent for participation 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 |
|---|---|---|
| Polymer clips for closure of the appendiceal stumpApplication of polymer clips to the appendiceal stump | Procedure or surgery | Polymer clips |
| Endoloops for closure of the appendiceal stumpApplication of endoloops to the appendiceal stump | Procedure or surgery | Endoloops |
Primary outcome
Operative time
Time frame: Intraoperative
Is there difference in the overall operating time between the two cohorts
3 secondary outcomes
Length of hospital stay (postoperative)
Time frame: Up to 14 days
Complications
Time frame: 30 days
Readmissions to hospital within 30 days of surgery
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymer clips for closure of the appendiceal stump and Endoloops for closure of the appendiceal stump in people with Appendicitis, run by National Health Service, United Kingdom at 1 site in United Kingdom.
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 3 inclusion and 4 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 12 Apr 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 United Kingdom. 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?
Contact Michael S Wilson (01382660111 ext. 4479, michaelwilson3@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperative). 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 12 Apr 2016.