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Polymer Clips Vs Endoloop for Appendicular Stump Ligation

Primary Purpose

Appendicitis, Polymer Clips, Surgitie

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
polymer clip
endoloop
Sponsored by
Services Hospital, Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

13 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Patients of either gender with age ranging from 15 to 60 years. 2. Patients with MANTRELS score of 7 or above on admission.

Exclusion Criteria:

- 1. Patients having co-morbid factors such as diabetes, chronic liver disease and ischemic heart disease on previous / past medical history.

2. Patients with history and clinical findings suggestive of appendicular mass. 3. Patients with known gastrointestinal malignancies. 4. Patients with history of any abdominal surgery

Sites / Locations

  • Services Hospital Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

polymer clip

endoloop

Arm Description

polymer clips will be used to ligate the appendicular stump. and time and ease of appliction and cost of clips will be calculated

endoloops will be used to ligate the appendicular stump an time and ease of application and cost of loops will be calculated

Outcomes

Primary Outcome Measures

surgeons perception about ease of application of clips or endoloop
surgeons will be asked after the operation that which they think is easy way to ligate stump polyemr clip of endoloop
time of application of endoloop and polymer clip
time will be calculated in minutes since inserting instrument in abdomen till ligation of stump of appendix

Secondary Outcome Measures

cost of clips and cost of endoloop
cost of clips and cost of endoloop will be calculated at market price

Full Information

First Posted
July 8, 2018
Last Updated
July 8, 2018
Sponsor
Services Hospital, Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT03591419
Brief Title
Polymer Clips Vs Endoloop for Appendicular Stump Ligation
Official Title
To Compare the Outcome of Polymer Clips and Endoloop Ligatures for the Closure of Appendicular Stump on the Cost of Operation and Intra-operative Time in Laparoscopic Appendectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
laparoscopic appendectomy is the gold standard procedure now a days for the treatment of appendicitis. Polymer clips are new modality used for the ligation of appendicular stump. this study aims to compare the polymer clips with endoloop for the ligation of appendicular stump.
Detailed Description
Appendicitis is defined as an inflammation of the inner lining of the vermiform appendix that spreads to its other parts.[1] Features of acute appendicitis include right lower quadrant pain starting from epigastrium or umblical region which then shifts to right iliac fossa, associated with nausea, vomiting, anorexia or fever. On examination tenderness, rebound tenderness and guarding are usually present in right iliac fossa. Various laboratory investigations to diagnose appendicitis include complete blood count, ultrasound abdomen and CT scan abdomen. A large, single center study found that multi detector CT (MDCT) has a high rate of sensitivity and specificity (98.5% and 98%, respectively) for diagnosing acute appendicitis.[2] Appendicitis may occur for several reasons, such as an infection of the appendix, but the most important factor is the obstruction of the appendiceal lumen. Left untreated, appendicitis has the potential for severe complications, including perforation, peritonitis, sepsis, and may even cause death. Appendectomy is the most effective treatment of acute appendicitis and the most commonly performed operation of emergency surgery worldwide. Since the introduction of laparoscopy, the minimally invasive technique is being used to perform appendectomy. According to the 2010 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guideline, the indications for laparoscopic appendectomy are identical to those for open appendectomy.[3] Laparoscopic appendectomy (LA) is a safe and easy operation offering well-known advantages of laparoscopy, such as faster postoperative recovery, good cosmetics, less wound complications and less postoperative pain although laparoscopic method is expensive as compared to open method. Various methods (endoloop, titanium clips, polymer clips and endo-staplers) are used to ligate the stump and mesentery of appendix during laparoscopic appendectomy. Endoloops are being used widely for the ligation of mesentery since long but it is expensive and requires more expertise and skill to use the endoloops and most of the times 2-3 endoloops are used which increases the cost of operation. Now-a-days polymer clips are used for the ligation of stump and mesentery which are economical and require less expertise as compared to that required for the use of polymer clips. More over both of these methods does not have any side effects as investigated by various investigators in previous studies.[4][5][6] In a study done by Delibegović S. and Matović E.[4] who compared the polymer clips with the endoloop showed that mean operative time was 47.1 ± 6.7 min in the first group where the base was secured by endoloop ligatures, and was 38.7 ± 5.0 min in the group where the base was secured by hem-o-lok clips. The cost of the three hem-o-lok clips was 76.9 Euros, and that of the three endoloop ligatures was 88.5 Euros and according to them the simplicity of application, shorter time of operation, and lower cost of hem-o-lok clips are advantages of this way of securing of the base of the appendix in relation to the standard endoloop procedure. Various other studies have found similar results.[5],[6]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Polymer Clips, Surgitie

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polymer clip
Arm Type
Experimental
Arm Description
polymer clips will be used to ligate the appendicular stump. and time and ease of appliction and cost of clips will be calculated
Arm Title
endoloop
Arm Type
Active Comparator
Arm Description
endoloops will be used to ligate the appendicular stump an time and ease of application and cost of loops will be calculated
Intervention Type
Device
Intervention Name(s)
polymer clip
Intervention Description
polymer clips will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated
Intervention Type
Device
Intervention Name(s)
endoloop
Intervention Description
endoloop will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated
Primary Outcome Measure Information:
Title
surgeons perception about ease of application of clips or endoloop
Description
surgeons will be asked after the operation that which they think is easy way to ligate stump polyemr clip of endoloop
Time Frame
4 months
Title
time of application of endoloop and polymer clip
Description
time will be calculated in minutes since inserting instrument in abdomen till ligation of stump of appendix
Time Frame
4 months
Secondary Outcome Measure Information:
Title
cost of clips and cost of endoloop
Description
cost of clips and cost of endoloop will be calculated at market price
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients of either gender with age ranging from 15 to 60 years. 2. Patients with MANTRELS score of 7 or above on admission. Exclusion Criteria: - 1. Patients having co-morbid factors such as diabetes, chronic liver disease and ischemic heart disease on previous / past medical history. 2. Patients with history and clinical findings suggestive of appendicular mass. 3. Patients with known gastrointestinal malignancies. 4. Patients with history of any abdominal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof.Mahmood Ayyaz, MBBS,FACS
Organizational Affiliation
Services Hospital, Lahore
Official's Role
Study Director
Facility Information:
Facility Name
Services Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Polymer Clips Vs Endoloop for Appendicular Stump Ligation

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