Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy
Primary Purpose
Appendicitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polymeric non absorbable clips
endoloops
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis
Eligibility Criteria
Inclusion Criteria:
- . Able to give informed consent for inclusion in the study
- Age of the patient : Any age
Exclusion Criteria:
• Intraoperative decision to convert to open appendicectomy
- Primary open appendicectomy
- Unable to give informed consent for participation in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
endoloop ligation
non absorbable polymeric clips
Arm Description
securing appendicular base with endoloops
securing appendicular base with non absorbable polymeric clips
Outcomes
Primary Outcome Measures
Operative time
Is there difference in the overall operating time between the two cohorts
Secondary Outcome Measures
Complications
Is there a difference in the rate of intraoperative and postoperative complications
Length of hospital stay (postoperative)
Is there a significant difference in the length of postoperative stay between the two cohorts
Readmission to hospital
Is there a difference in the thirty day readmission rates between the two cohorts
Time of Application
Time of application of endoloop, polymeric clip measured from introducing of instruments to cutting the base of appendix
Full Information
NCT ID
NCT04094480
First Posted
September 17, 2019
Last Updated
September 18, 2019
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04094480
Brief Title
Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy
Official Title
A Comparison Between Non Absorbable Polymeric Clips and Endoloop Ligatures in Securing Appendicular Stump in Laparoscopic Appendicectomy at Assiut University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
a) Compare between Nonabsorbable Polymeric Clips and Endoloop ligatures regarding:
technical difficulties.
operation time.
cost effectiveness.
postoperative complications.
inpatient stay.
Detailed Description
Laparoscopic appendectomy is gradually evolving as the 'gold standard' in the treatment of acute appendicitis, especially in the obese, elderly, and in cases where the diagnosis is uncertain . There are clear benefits with the laparoscopic approach in terms of decreased pain and faster recovery than the open approach . However, disadvantages like a higher incidence of intra-abdominal collection, longer operating time, and higher costs have been documented. These may be dependent on the technique of appendicular stump closure. Therefore, the technique for appendiceal stump closure is crucial in laparoscopic appendectomy.
Laparoscopic appendectomy was first described by Semm in 1983 and is currently preferred approach for an appendectomy for many surgeons. Numerous methods of stump closure have been used, like intracorporeal suturing of the stump endoloop application, endostapler application LigaSure customized titanium clip application, and, more recently, using nonabsorbable plastic clips . Many of these techniques are either time consuming or expensive, or not available universally.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endoloop ligation
Arm Type
Active Comparator
Arm Description
securing appendicular base with endoloops
Arm Title
non absorbable polymeric clips
Arm Type
Active Comparator
Arm Description
securing appendicular base with non absorbable polymeric clips
Intervention Type
Device
Intervention Name(s)
polymeric non absorbable clips
Intervention Description
a method to secure appendicular stump
Intervention Type
Other
Intervention Name(s)
endoloops
Intervention Description
a method to secure appendicular stump
Primary Outcome Measure Information:
Title
Operative time
Description
Is there difference in the overall operating time between the two cohorts
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Complications
Description
Is there a difference in the rate of intraoperative and postoperative complications
Time Frame
30 days
Title
Length of hospital stay (postoperative)
Description
Is there a significant difference in the length of postoperative stay between the two cohorts
Time Frame
Up to 14 days
Title
Readmission to hospital
Description
Is there a difference in the thirty day readmission rates between the two cohorts
Time Frame
30 days
Title
Time of Application
Description
Time of application of endoloop, polymeric clip measured from introducing of instruments to cutting the base of appendix
Time Frame
120 min
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. Able to give informed consent for inclusion in the study
Age of the patient : Any age
Exclusion Criteria:
• Intraoperative decision to convert to open appendicectomy
Primary open appendicectomy
Unable to give informed consent for participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed ashraf, master
Phone
01060624371
Email
akhel93@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Morssy mohamed, professor
Phone
01006234545
Email
morssy.mohamed@med.au.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesham Ali, professor
Organizational Affiliation
Assiut university faculty of medicine
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
31446471
Citation
Kliuchanok K, Kessler W, Partecke I, Walschus U, Schulze T, Heidecke CD, Patrzyk M. A comparison of non-absorbable polymeric clips and staplers for laparoscopic appendiceal stump closure: analysis of 618 adult patients. Langenbecks Arch Surg. 2019 Sep;404(6):711-716. doi: 10.1007/s00423-019-01814-w. Epub 2019 Aug 24.
Results Reference
background
PubMed Identifier
29543058
Citation
Wilson M, Maniam P, Ibrahim A, Makaram N, Knight SR, Patil P. Polymeric clips are a quicker and cheaper alternative to endoscopic ligatures for securing the appendiceal stump during laparoscopic appendicectomy. Ann R Coll Surg Engl. 2018 Jul;100(6):454-458. doi: 10.1308/rcsann.2018.0036. Epub 2018 Mar 15.
Results Reference
background
PubMed Identifier
29190038
Citation
Mannu GS, Sudul MK, Bettencourt-Silva JH, Cumber E, Li F, Clark AB, Loke YK. Closure methods of the appendix stump for complications during laparoscopic appendectomy. Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD006437. doi: 10.1002/14651858.CD006437.pub3.
Results Reference
background
PubMed Identifier
29098432
Citation
Delibegovic S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018 May;32(5):2295-2299. doi: 10.1007/s00464-017-5924-z. Epub 2017 Nov 2.
Results Reference
background
PubMed Identifier
27996377
Citation
Pogorelic Z, Kostovski B, Jeroncic A, Susnjar T, Mrklic I, Jukic M, Juric I. A Comparison of Endoloop Ligatures and Nonabsorbable Polymeric Clips for the Closure of the Appendicular Stump During Laparoscopic Appendectomy in Children. J Laparoendosc Adv Surg Tech A. 2017 Jun;27(6):645-650. doi: 10.1089/lap.2016.0433. Epub 2016 Dec 20.
Results Reference
background
Learn more about this trial
Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy
We'll reach out to this number within 24 hrs