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AppendicitisNCT03591419

Polymer Clips Vs Endoloop for Appendicular Stump Ligation

A study testing polymer clip and endoloop in people with Appendicitis and Polymer Clips, run by Services Hospital, Lahore at 1 site in Pakistan.

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

laparoscopic appendectomy is the gold standard procedure now a days for the treatment of appendicitis. Polymer clips are new modality used for the ligation of appendicular stump. this study aims to compare the polymer clips with endoloop for the ligation of appendicular stump. Read more about this study

Who is it for?
Ages 13 to 65 years
Conditions the study is for
Appendicitis, Polymer Clips, Surgitie
What is being tested?
polymer clip and endoloop
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePakistan
Study dates
1 Dec 2016to 30 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

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 13 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 1. Patients of either gender with age ranging from 15 to 60 years. 2. Patients with MANTRELS score of 7 or above on admission.

Who cannot join

  • 1. Patients having co-morbid factors such as diabetes, chronic liver disease and ischemic heart disease on previous / past medical history.
  • 2. Patients with history and clinical findings suggestive of appendicular mass. 3. Patients with known gastrointestinal malignancies. 4. Patients with history of any abdominal surgery

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Services Hospital Lahore

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: To Compare the Outcome of Polymer Clips and Endoloop Ligatures for the Closure of Appendicular Stump on the Cost of Operation and Intra-operative Time in Laparoscopic Appendectomy

laparoscopic appendectomy is the gold standard procedure now a days for the treatment of appendicitis. Polymer clips are new modality used for the ligation of appendicular stump. this study aims to compare the polymer clips with endoloop for the ligation of appendicular stump.

Read the detailed description

Appendicitis is defined as an inflammation of the inner lining of the vermiform appendix that spreads to its other parts.[1] Features of acute appendicitis include right lower quadrant pain starting from epigastrium or umblical region which then shifts to right iliac fossa, associated with nausea, vomiting, anorexia or fever. On examination tenderness, rebound tenderness and guarding are usually present in right iliac fossa.

Various laboratory investigations to diagnose appendicitis include complete blood count, ultrasound abdomen and CT scan abdomen. A large, single center study found that multi detector CT (MDCT) has a high rate of sensitivity and specificity (98.5% and 98%, respectively) for diagnosing acute appendicitis.[2] Appendicitis may occur for several reasons, such as an infection of the appendix, but the most important factor is the obstruction of the appendiceal lumen. Left untreated, appendicitis has the potential for severe complications, including perforation, peritonitis, sepsis, and may even cause death.

Appendectomy is the most effective treatment of acute appendicitis and the most commonly performed operation of emergency surgery worldwide. Since the introduction of laparoscopy, the minimally invasive technique is being used to perform appendectomy. According to the 2010 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guideline, the indications for laparoscopic appendectomy are identical to those for open appendectomy.[3] Laparoscopic appendectomy (LA) is a safe and easy operation offering well-known advantages of laparoscopy, such as faster postoperative recovery, good cosmetics, less wound complications and less postoperative pain although laparoscopic method is expensive as compared to open method.

Various methods (endoloop, titanium clips, polymer clips and endo-staplers) are used to ligate the stump and mesentery of appendix during laparoscopic appendectomy.

Endoloops are being used widely for the ligation of mesentery since long but it is expensive and requires more expertise and skill to use the endoloops and most of the times 2-3 endoloops are used which increases the cost of operation. Now-a-days polymer clips are used for the ligation of stump and mesentery which are economical and require less expertise as compared to that required for the use of polymer clips. More over both of these methods does not have any side effects as investigated by various investigators in previous studies.[4][5][6] In a study done by Delibegović S. and Matović E.[4] who compared the polymer clips with the endoloop showed that mean operative time was 47.1 ± 6.7 min in the first group where the base was secured by endoloop ligatures, and was 38.7 ± 5.0 min in the group where the base was secured by hem-o-lok clips. The cost of the three hem-o-lok clips was 76.9 Euros, and that of the three endoloop ligatures was 88.5 Euros and according to them the simplicity of application, shorter time of operation, and lower cost of hem-o-lok clips are advantages of this way of securing of the base of the appendix in relation to the standard endoloop procedure. Various other studies have found similar results.[5],[6]

Being tested
polymer clip, endoloop
Medical subject headings
Appendicitis

What participants receive

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

  • polymer clipDevice

    polymer clips will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated

  • endoloopDevice

    endoloop will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated

Study groups in NCT03591419
Study groupRoleWhat they receive
polymer clipExperimentalpolymer clips will be used to ligate the appendicular stump. and time and ease of appliction and cost of clips will be calculated
Receives: Device: polymer clip
endoloopActive comparatorendoloops will be used to ligate the appendicular stump an time and ease of application and cost of loops will be calculated
Receives: Device: endoloop

What is being measured

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

  1. surgeons perception about ease of application of clips or endoloop

    surgeons will be asked after the operation that which they think is easy way to ligate stump polyemr clip of endoloop

    Measured: 4 months

  2. time of application of endoloop and polymer clip

    time will be calculated in minutes since inserting instrument in abdomen till ligation of stump of appendix

    Measured: 4 months

Secondary outcomes (1)
  1. cost of clips and cost of endoloop

    cost of clips and cost of endoloop will be calculated at market price

    Measured: 4 months

Timeline

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

  1. First posted19 Jul 2018
  2. Study start1 Dec 2016
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

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
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03591419
Sponsor's protocol ID
L.Appy
Status last verified
Jul 2018
First submitted
8 Jul 2018
Last updated
19 Jul 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing polymer clip and endoloop in people with Appendicitis and Polymer Clips, run by Services Hospital, Lahore at 1 site in Pakistan.

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 2 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 19 Jul 2018. 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

surgeons perception about ease of application of clips or endoloop (time frame: 4 months). The study lists 2 primary outcomes in all. 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 19 Jul 2018.

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