NCT02726152

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

March 18, 2016

Last Update Submit

April 11, 2016

Conditions

Appendicitis

Keywords

Diagnostic laparoscopyAcute appendicitisAppendiceal stump

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Is there difference in the overall operating time between the two cohorts

    Intraoperative

Secondary Outcomes (3)

  • Length of hospital stay (postoperative)

    Up to 14 days

  • Complications

    30 days

  • Readmissions to hospital within 30 days of surgery

    30 days

Study Arms (2)

Polymer clips

EXPERIMENTAL

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

Procedure: Polymer clips for closure of the appendiceal stump

Endoloops

ACTIVE COMPARATOR

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

Procedure: Endoloops for closure of the appendiceal stump

Interventions

Polymer clips for closure of the appendiceal stumpPROCEDURE

Application of polymer clips to the appendiceal stump

Polymer clips
Endoloops for closure of the appendiceal stumpPROCEDURE

Application of endoloops to the appendiceal stump

Endoloops

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical suspicion of acute appendicitis who are to do undergo diagnostic laparoscopy +/- appendicectomy
  • Over the age of 16 years

You may not qualify if:

  • Intraoperative decision to convert to open appendicectomy
  • Primary open appendicectomy
  • Under 16 years old
  • Unable to give informed consent for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninewells Hospital

Dundee, Angus, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Central Study Contacts

Michael S Wilson

CONTACT

01382660111michaelwilson3@nhs.net

Pradeep Patil

CONTACT

01382 660111pradeeppatil@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialty Registrar, General Surgery

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 1, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

April 12, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)