Polymer Clips Versus Endoloops for Closure of the Appendiceal Stump During Emergency Laparoscopic Appendicectomy

Appendicitis Clinical Trial

— PECAS  

Official title:

Randomised Control Trial: Polymer Clips Versus Endoloops for Closure of the Appendiceal Stump During Emergency Laparoscopic Appendicectomy (The PECAS Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02726152
• Other study ID #: 2015SA03
• Status: Not yet recruiting
• Phase: N/A
• First received: March 18, 2016
• Last updated: April 11, 2016
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: April 2016
• Source: National Health Service, United Kingdom
• Contact: Michael S Wilson
• Phone: 01382660111
• Email: michaelwilson3[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Intraoperative decision to convert to open appendicectomy

• Primary open appendicectomy

• Under 16 years old

• Unable to give informed consent for participation in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Polymer clips for closure of the appendiceal stump
Application of polymer clips to the appendiceal stump
• Endoloops for closure of the appendiceal stump
Application of endoloops to the appendiceal stump

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital	Dundee	Angus

Sponsors (1)

Lead Sponsor	Collaborator
National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Is there difference in the overall operating time between the two cohorts	Intraoperative	No
Secondary	Length of hospital stay (postoperative)	Is there a significant difference in the length of postoperative stay between the two cohorts	Up to 14 days	No
Secondary	Complications	Is there a difference in the rate of intraoperative and postoperative complications	30 days	Yes
Secondary	Readmissions to hospital within 30 days of surgery	Is there a difference in the thirty day readmission rates between the two cohorts	30 days	No