Polymer Clips Vs Endoloop for Appendicular Stump Ligation

July 8, 2018 updated by: Dr. SamiUllah, Services Hospital, Lahore

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

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.

Study Overview

Status

Completed

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]

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: polymer clip
polymer clips will be used to ligate the appendicular stump. and time and ease of appliction and cost of clips will be calculated
polymer clips will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated
Active Comparator: endoloop
endoloops will be used to ligate the appendicular stump an time and ease of application and cost of loops will be calculated
endoloop will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgeons perception about ease of application of clips or endoloop
Time Frame: 4 months
surgeons will be asked after the operation that which they think is easy way to ligate stump polyemr clip of endoloop
4 months
time of application of endoloop and polymer clip
Time Frame: 4 months
time will be calculated in minutes since inserting instrument in abdomen till ligation of stump of appendix
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost of clips and cost of endoloop
Time Frame: 4 months
cost of clips and cost of endoloop will be calculated at market price
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Prof.Mahmood Ayyaz, MBBS,FACS, Services Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

July 8, 2018

First Submitted That Met QC Criteria

July 8, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 8, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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