AppendicitisNCT03591419
Polymer Clips Vs Endoloop for Appendicular Stump Ligation
A study testing polymer clip and endoloop in people with Appendicitis and Polymer Clips, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Appendicitis, Polymer Clips, Surgitie
- What is being tested?
- polymer clip and endoloop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2016to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients of either gender with age ranging from 15 to 60 years. 2. Patients with MANTRELS score of 7 or above on admission.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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]
- Conditions
- Appendicitis, Polymer Clips, Surgitie
- Being tested
- polymer clip, endoloop
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymer clipDevice
polymer clips will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated
endoloopDevice
endoloop will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated
| Study group | Role | What they receive |
|---|---|---|
| polymer clip | Experimental | polymer clips will be used to ligate the appendicular stump. and time and ease of appliction and cost of clips will be calculated Receives: Device: polymer clip |
| endoloop | Active comparator | endoloops will be used to ligate the appendicular stump an time and ease of application and cost of loops will be calculated Receives: Device: endoloop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
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
Measured: 4 months
Secondary outcomes (1)
cost of clips and cost of endoloop
cost of clips and cost of endoloop will be calculated at market price
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Dec 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Prof.Mahmood Ayyaz, MBBS,FACS, Study director, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591419
- Sponsor's protocol ID
- L.Appy
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03591419
- Acronym / sponsor ID
- L.Appy
- Conditions
- Appendicitis, Polymer Clips, Surgitie
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polymer clip | Experimental | Device: polymer clippolymer clips will be used to ligate the appendicular stump. and time and ease of appliction and cost of clips will be calculated |
| endoloop | Active comparator | Device: endoloopendoloops will be used to ligate the appendicular stump an time and ease of application and cost of loops will be calculated |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients of either gender with age ranging from 15 to 60 years. 2. Patients with MANTRELS score of 7 or above on admission.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polymer clippolymer clips will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated | Device | polymer clip |
| endoloopendoloop will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated | Device | endoloop |
Primary outcome
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
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
1 secondary outcome
cost of clips and cost of endoloop
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof.Mahmood Ayyaz, MBBS,FACS study director
Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polymer clip and endoloop in people with Appendicitis and Polymer Clips, run by Services Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgeons perception about ease of application of clips or endoloop (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.