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AppendicitisNCT02941640

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

A study testing E group, S group and H group in people with Appendicitis, run by University Clinical Center Tuzla at 1 site in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

During laparoscopic appendectomy, the base of the appendix is usually secured by an endoloop ligature or the stapler. Non-absorbable plastic hem-o-lok clip was shown as an alternative technique with which laparoscopic appendectomy was done faster and cheaper than the standard techniques. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Appendicitis
What is being tested?
E group, S group and H group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBosnia and Herzegovina
Study dates
2 Oct 2016to 30 Jan 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with accute appendicits

Who cannot join

  • Patient younger than 18 years

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site
  • University Clinical Center Tuzla

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

About this study

During laparoscopic appendectomy, the base of the appendix is usually secured by an endoloop ligature or the stapler. Non-absorbable plastic hem-o-lok clip was shown as an alternative technique with which laparoscopic appendectomy was done faster and cheaper than the standard techniques. However, biocompatibility of different materials udes in securing the base of appendix is different. It was observed that stapler's clips made by titanium caused the mildest inflammatory reaction and creation of adhesions. Disadvantages of stapler's are their high price.

Titanium clips made for the use in laparoscopic appendectomy are safe and effective option in securing the appendicular stump in laparoscopic appendectomy. They have potential advantages over stapler, because they have the same bio compatibility, and their price is lower.

Read the detailed description

Prospective study was conducted in the period from 02. October 2016 to 30. December 2016. The patients were randomly divided into four groups; in the first group, the base of the appendix was secured using one endoloop ligature, in the second group using the 45-mm stapler, in third group using only one non-absorbable Hem-o-lok clip and in fourth group using titanium DS clip.

Patients were assessed for eligibility at the emergency station by the surgeon on-call once the diagnosis of acute appendicitis was established. A dedicated study nurse assigned randomly to Endoloop (E group) or Stapler (S group), or Hem-o-lock (H group), or DS clip (DS group) by picking out of a box and opening a sealed opaque randomization envelope in operating theatre. The details of the allocated treatments (''E'' or ''S'', or (''H'' or (''Ds'' ) were given on cards contained in sealed opaque envelopes. All sealed opaque envelopes were previously prepared with a 1 : 1 ratio, well shuffled, and put into a box by the dedicated study nurse. No blinding was performed.

Data collected included age, gender, surgery time, time of hem-o-lok clip application, hospital stay, costs associated with these and intra- and post-operative complications.

Technique

The patient was placed in supine position, combined with Trendelenburg position and left lateral position (10º - 15º, incline towards the surgeon). The surgeon used the French position (between legs of patient) and an assistant stood on the left side, and monitor was on the right side of the patient. The bladder was decompressed with the Foley catheter to avoid an injury during insertion of the supra-pubic ports. Pneumoperitoneum was established with the Veress needle through the umbilicus and then an endoscope was introduced. Under direct vision, one 12 mm trocar was inserted in suprapubic region, a little to the left, and 5 mm trocar in the right lower quadrant, to the level of the first 12 mm port, in order to acquire triangulation. After that the abdominal cavity was inspected.

When the decision was made to perform appendectomy, mesoappendix was mobilized and dissected using an harmonic scalpel (Ethicon, Endosurgery, Cincinnati, OH). In the first group, the base of the appendix was secured using one endoloop, and on the distal part which would be removed, another endoloop was used. In the second group, the appendix was secured by a 45 mm stapler (thick charge) (Ethicon, Endosurgery, Cincinnati, OH). In the third group, one hem-o-lok clip, size XL (Hem-o-lock, Weck Closure Systems, Research Triangle Park, NC, USA) was placed on the base the appendix by a special applier for the hem-o-lok clip, and on the distal part which would be removed, another clip was used. In the fourth group, one titanium DS clip (Aesculap AG, Tuttlingen, Germany) was placed on the base of appendix by endoscopic clip applier (12 mm) and on the distal part which would be removed, another DS clip was used.

Conditions
Appendicitis
Being tested
E group, S group, H group, DS group, Endoloop
Keywords
Laparoscopic appendectomy, Endoloop, Stapler, Hem-o-lok clip, DS clip
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E groupProcedure or surgery

    Also called Endoloop

    The securing the base of appendix by endoloop.

  • S groupProcedure or surgery

    Also called Stapler

    The securing the base of appendix by Stapler.

  • H groupProcedure or surgery

    Also called Hem-o-lok clip

    The securing the base of appendix by Hem-o-lok clip.

  • DS groupProcedure or surgery

    Also called DS clip

    The securing the base of appendix by DS clip.

  • EndoloopDevice

  • StaplerDevice

  • Hem-o-lok clipDevice

  • DS clipDevice

Study groups in NCT02941640
Study groupRoleWhat they receive
Laparoscopic appendectomy. E group.ExperimentalThe securing the base of appendix by Endo-loop.
Receives: Procedure: E group; Device: Endoloop
Laparoscopic appendectomy. S group.ExperimentalThe securing the base of appendix by stapler.
Receives: Procedure: S group; Device: Stapler
Laparoscopic appendectomy. H group.ExperimentalThe securing the base of appendix by Hem-o-lok clip.
Receives: Procedure: H group; Device: Hem-o-lok clip
Laparoscopic appendectomy. DS group.ExperimentalThe securing the base of appendix by DS clip.
Receives: Procedure: DS group; Device: DS clip

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Morbidity

    Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day.

    Measured: 30 days

Secondary outcomes (5)
  1. Intra-perative Complications

    Complications that appear during operative procedure

    Measured: 120 min.

  2. Postoperative Complications

    Complications that appear after operative procedure

    Measured: 30 days

  3. Operative Time

    Time of operative procedure

    Measured: 120 min.

  4. Time of Application

    Time of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix

    Measured: 120 min

  5. Hospital Stay

    Length of hospitalization

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2016 (estimated)
  2. Study start2 Oct 2016
  3. Primary completion30 Dec 2016
  4. Study completion30 Jan 2017

Resources

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
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02941640
Sponsor's protocol ID
04-09/2-12/16
Status last verified
Jun 2017
First submitted
12 Oct 2016
Last updated
14 Jun 2017
Data monitoring committee
Yes
Individual data sharing
No: We have no plan to share IPD.

Questions about this trial

What is this clinical trial studying?

A study testing E group, S group and H group in people with Appendicitis, run by University Clinical Center Tuzla at 1 site in Bosnia and Herzegovina.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jun 2017. 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 Bosnia and Herzegovina. 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?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Morbidity (time frame: 30 days). 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 14 Jun 2017.

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