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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hand-made Extracorporeal Knotting Versus Clip for Stump Closure in Laparoscopic Appendectomy

NCT07281612

Appendicectomy

COMPLETED EARLY_PHASE1

Polymer Clips Vs Endoloop for Appendicular Stump Ligation

NCT03591419

Appendicitis Polymer Clips Surgitie

COMPLETED NA

Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy

NCT02941640

Appendicitis

COMPLETED NA

Closure of the Appendiceal Stump

NCT06443749

Appendectomy

NOT_YET_RECRUITING NA

Comparison Between Metallic Clip Ligation and Suture Ligation of Appendicular Stump in Laparoscopic Appendectomy

NCT07129746

Laparoscopic Appendectomy

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Appendicitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Polymer clips

Patients will be randomised to polymer clips for closure of the appendiceal stump

Group Type EXPERIMENTAL

Polymer clips for closure of the appendiceal stump

Intervention Type PROCEDURE

Application of polymer clips to the appendiceal stump

Endoloops

Patients will be randomised to endoloops for closure of the appendiceal stump

Group Type ACTIVE_COMPARATOR

Endoloops for closure of the appendiceal stump

Intervention Type PROCEDURE

Application of endoloops to the appendiceal stump

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polymer clips for closure of the appendiceal stump

Application of polymer clips to the appendiceal stump

Intervention Type PROCEDURE

Endoloops for closure of the appendiceal stump

Application of endoloops to the appendiceal stump

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes