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

April 11, 2016 updated by: Michael Wilson, National Health Service, United Kingdom

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polymer clips
Patients will be randomised to polymer clips for closure of the appendiceal stump
Procedure: Polymer clips for closure of the appendiceal stump
Application of polymer clips to the appendiceal stump
Active Comparator: Endoloops
Patients will be randomised to endoloops for closure of the appendiceal stump
Procedure: Endoloops for closure of the appendiceal stump
Application of endoloops to the appendiceal stump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Intraoperative
Is there difference in the overall operating time between the two cohorts
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay (postoperative)
Time Frame: Up to 14 days
Is there a significant difference in the length of postoperative stay between the two cohorts
Up to 14 days
Complications
Time Frame: 30 days
Is there a difference in the rate of intraoperative and postoperative complications
30 days
Readmissions to hospital within 30 days of surgery
Time Frame: 30 days
Is there a difference in the thirty day readmission rates between the two cohorts
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015SA03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Appendicitis

Clinical Trials on Polymer clips for closure of the appendiceal stump

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe