Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

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. 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: 
      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.
    

Intervention name(s): E group; S group; H group; DS group; Endoloop; Stapler; Hem-o-lok clip; DS clip
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Device; Device; Device; Device
Intervention description(s): The securing the base of appendix by endoloop.; The securing the base of appendix by Stapler.; The securing the base of appendix by Hem-o-lok clip.; The securing the base of appendix by DS clip.
Other intervention name(s): Endoloop; Stapler; Hem-o-lok clip; DS clip
Intervention MeSH terms: Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Laparoscopic appendectomy; Endoloop; Stapler; Hem-o-lok clip; DS clip