Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
NCT ID: NCT02941640
Last Updated: 2017-06-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2016-10-02
2017-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Use of the Hem-o-lok Clip in Appendectomy: Single or Double?
NCT04387370
Closure of the Appendiceal Stump
NCT06443749
Polymer Clips Vs Endoloop for Appendicular Stump Ligation
NCT03591419
Comparison Between Metallic Clip Ligation and Suture Ligation of Appendicular Stump in Laparoscopic Appendectomy
NCT07129746
Closure of the Appendix Stump in Laparoscopic Appendectomy
NCT03930667
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Laparoscopic appendectomy. E group.
The securing the base of appendix by Endo-loop.
E group
The securing the base of appendix by endoloop.
Endoloop
Laparoscopic appendectomy. S group.
The securing the base of appendix by stapler.
S group
The securing the base of appendix by Stapler.
Stapler
Laparoscopic appendectomy. H group.
The securing the base of appendix by Hem-o-lok clip.
H group
The securing the base of appendix by Hem-o-lok clip.
Hem-o-lok clip
Laparoscopic appendectomy. DS group.
The securing the base of appendix by DS clip.
DS group
The securing the base of appendix by DS clip.
DS clip
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
E group
The securing the base of appendix by endoloop.
S group
The securing the base of appendix by Stapler.
H group
The securing the base of appendix by Hem-o-lok clip.
DS group
The securing the base of appendix by DS clip.
Endoloop
Stapler
Hem-o-lok clip
DS clip
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Clinical Center Tuzla
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Samir Delibegovic
MD, Ph.D, Professor of surgery, Head of colorectal department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enver Zerem, MD, PhD
Role: STUDY_CHAIR
University Clinical Center Tuzla
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Clinical Center Tuzla
Tuzla, , Bosnia and Herzegovina
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
04-09/2-12/16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.