Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
Primary Purpose
Appendicitis
Status
Completed
Phase
Not Applicable
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
E group
S group
H group
DS group
Endoloop
Stapler
Hem-o-lok clip
DS clip
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring Laparoscopic appendectomy, Endoloop, Stapler, Hem-o-lok clip, DS clip
Eligibility Criteria
Inclusion Criteria:
- Patient with accute appendicits
Exclusion Criteria:
- Patient younger than 18 years
Sites / Locations
- University Clinical Center Tuzla
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Laparoscopic appendectomy. E group.
Laparoscopic appendectomy. S group.
Laparoscopic appendectomy. H group.
Laparoscopic appendectomy. DS group.
Arm Description
The securing the base of appendix by Endo-loop.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Intra-perative Complications
Complications that appear during operative procedure
Postoperative Complications
Complications that appear after operative procedure
Operative Time
Time of operative procedure
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
Hospital Stay
Length of hospitalization
Full Information
NCT ID
NCT02941640
First Posted
October 12, 2016
Last Updated
June 10, 2017
Sponsor
University Clinical Center Tuzla
1. Study Identification
Unique Protocol Identification Number
NCT02941640
Brief Title
Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
Official Title
Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2, 2016 (Actual)
Primary Completion Date
December 30, 2016 (Actual)
Study Completion Date
January 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Clinical Center Tuzla
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Laparoscopic appendectomy, Endoloop, Stapler, Hem-o-lok clip, DS clip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The study included 120 patients randomly divided into four groups with 30 patients in each. The study was not blinded. The nurse designated for participation in this study allocated the patients randomly into four groups by selecting a sealed opaque envelope from a box and opening it in the operating theatre. A card inside the envelope contained name of the treatment. All the envelopes were prepared in advance in a ratio of 1:4, shuffled well, and placed in the box by the same nurse.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic appendectomy. E group.
Arm Type
Experimental
Arm Description
The securing the base of appendix by Endo-loop.
Arm Title
Laparoscopic appendectomy. S group.
Arm Type
Experimental
Arm Description
The securing the base of appendix by stapler.
Arm Title
Laparoscopic appendectomy. H group.
Arm Type
Experimental
Arm Description
The securing the base of appendix by Hem-o-lok clip.
Arm Title
Laparoscopic appendectomy. DS group.
Arm Type
Experimental
Arm Description
The securing the base of appendix by DS clip.
Intervention Type
Procedure
Intervention Name(s)
E group
Other Intervention Name(s)
Endoloop
Intervention Description
The securing the base of appendix by endoloop.
Intervention Type
Procedure
Intervention Name(s)
S group
Other Intervention Name(s)
Stapler
Intervention Description
The securing the base of appendix by Stapler.
Intervention Type
Procedure
Intervention Name(s)
H group
Other Intervention Name(s)
Hem-o-lok clip
Intervention Description
The securing the base of appendix by Hem-o-lok clip.
Intervention Type
Procedure
Intervention Name(s)
DS group
Other Intervention Name(s)
DS clip
Intervention Description
The securing the base of appendix by DS clip.
Intervention Type
Device
Intervention Name(s)
Endoloop
Intervention Type
Device
Intervention Name(s)
Stapler
Intervention Type
Device
Intervention Name(s)
Hem-o-lok clip
Intervention Type
Device
Intervention Name(s)
DS clip
Primary Outcome Measure Information:
Title
Overall Morbidity
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Intra-perative Complications
Description
Complications that appear during operative procedure
Time Frame
120 min.
Title
Postoperative Complications
Description
Complications that appear after operative procedure
Time Frame
30 days
Title
Operative Time
Description
Time of operative procedure
Time Frame
120 min.
Title
Time of Application
Description
Time of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix
Time Frame
120 min
Title
Hospital Stay
Description
Length of hospitalization
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with accute appendicits
Exclusion Criteria:
Patient younger than 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enver Zerem, MD, PhD
Organizational Affiliation
University Clinical Center Tuzla
Official's Role
Study Chair
Facility Information:
Facility Name
University Clinical Center Tuzla
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We have no plan to share IPD.
Learn more about this trial
Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
We'll reach out to this number within 24 hrs