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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Appendicitis

Intervention / Treatment
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* Procedure: E group
* Procedure: S group
* Procedure: H group
* Procedure: DS group
* Device: Endoloop
* Device: Stapler
* Device: Hem-o-lok clip
* Device: DS clip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with accute appendicits Exclusion Criteria: Patient younger than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic appendectomy. E group.<br>The securing the base of appendix by Endo-loop. | Procedure: E group<br>* The securing the base of appendix by endoloop.<br>* Other names: Endoloop;Device: Endoloop<br> <br> |
| Experimental: Laparoscopic appendectomy. S group.<br>The securing the base of appendix by stapler. | Procedure: S group<br>* The securing the base of appendix by Stapler.<br>* Other names: Stapler;Device: Stapler<br> <br> |
| Experimental: Laparoscopic appendectomy. H group.<br>The securing the base of appendix by Hem-o-lok clip. | Procedure: H group<br>* The securing the base of appendix by Hem-o-lok clip.<br>* Other names: Hem-o-lok clip;Device: Hem-o-lok clip<br> <br> |
| Experimental: Laparoscopic appendectomy. DS group.<br>The securing the base of appendix by DS clip. | Procedure: DS group<br>* The securing the base of appendix by DS clip.<br>* Other names: DS clip;Device: DS clip<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-perative Complications | Complications that appear during operative procedure | 120 min. | 
| Postoperative Complications | Complications that appear after operative procedure | 30 days | 
| Operative Time | Time of operative procedure | 120 min. | 
| 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 | 120 min | 
| Hospital Stay | Length of hospitalization | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic appendectomy, Endoloop, Stapler, Hem-o-lok clip, DS clip