AppendicitisNCT02941640
Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
A study testing E group, S group and H group in people with Appendicitis, run by University Clinical Center Tuzla at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- E group, S group and H group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 2 Oct 2016to 30 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with accute appendicits
Who cannot join
- Patient younger than 18 years
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
University Clinical Center Tuzla
Tuzla, 75000
About this study
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.
Read the 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.
- Conditions
- Appendicitis
- Being tested
- E group, S group, H group, DS group, Endoloop
- Keywords
- Laparoscopic appendectomy, Endoloop, Stapler, Hem-o-lok clip, DS clip
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E groupProcedure or surgery
Also called Endoloop
The securing the base of appendix by endoloop.
S groupProcedure or surgery
Also called Stapler
The securing the base of appendix by Stapler.
H groupProcedure or surgery
Also called Hem-o-lok clip
The securing the base of appendix by Hem-o-lok clip.
DS groupProcedure or surgery
Also called DS clip
The securing the base of appendix by DS clip.
EndoloopDevice
StaplerDevice
Hem-o-lok clipDevice
DS clipDevice
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic appendectomy. E group. | Experimental | The securing the base of appendix by Endo-loop. Receives: Procedure: E group; Device: Endoloop |
| Laparoscopic appendectomy. S group. | Experimental | The securing the base of appendix by stapler. Receives: Procedure: S group; Device: Stapler |
| Laparoscopic appendectomy. H group. | Experimental | The securing the base of appendix by Hem-o-lok clip. Receives: Procedure: H group; Device: Hem-o-lok clip |
| Laparoscopic appendectomy. DS group. | Experimental | The securing the base of appendix by DS clip. Receives: Procedure: DS group; Device: DS clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (5)
Intra-perative Complications
Complications that appear during operative procedure
Measured: 120 min.
Postoperative Complications
Complications that appear after operative procedure
Measured: 30 days
Operative Time
Time of operative procedure
Measured: 120 min.
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
Measured: 120 min
Hospital Stay
Length of hospitalization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start2 Oct 2016
- Primary completion30 Dec 2016
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Clinical Center Tuzla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir Delibegovic, University Clinical Center Tuzla
- Investigators
- Enver Zerem, MD, PhD, Study chair, University Clinical Center Tuzla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941640
- Sponsor's protocol ID
- 04-09/2-12/16
- Status last verified
- Jun 2017
- First submitted
- 12 Oct 2016
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We have no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT02941640
- Acronym / sponsor ID
- 04-09/2-12/16
- Conditions
- Appendicitis
- Keywords
- Laparoscopic appendectomy, Endoloop, Stapler, Hem-o-lok clip, DS clip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Clinical Center TuzlaUniversity, hospital or other
- Study start
- 2 Oct 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic appendectomy. E group. | Experimental | Procedure: E group, Device: EndoloopThe securing the base of appendix by Endo-loop. |
| Laparoscopic appendectomy. S group. | Experimental | Procedure: S group, Device: StaplerThe securing the base of appendix by stapler. |
| Laparoscopic appendectomy. H group. | Experimental | Procedure: H group, Device: Hem-o-lok clipThe securing the base of appendix by Hem-o-lok clip. |
| Laparoscopic appendectomy. DS group. | Experimental | Procedure: DS group, Device: DS clipThe securing the base of appendix by DS clip. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with accute appendicits
Key exclusion criteria (1 listed)
- Patient younger than 18 years
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 |
|---|---|---|
| E groupAlso: EndoloopThe securing the base of appendix by endoloop. | Procedure or surgery | Laparoscopic appendectomy. E group. |
| S groupAlso: StaplerThe securing the base of appendix by Stapler. | Procedure or surgery | Laparoscopic appendectomy. S group. |
| H groupAlso: Hem-o-lok clipThe securing the base of appendix by Hem-o-lok clip. | Procedure or surgery | Laparoscopic appendectomy. H group. |
| DS groupAlso: DS clipThe securing the base of appendix by DS clip. | Procedure or surgery | Laparoscopic appendectomy. DS group. |
| Endoloop | Device | Laparoscopic appendectomy. E group. |
| Stapler | Device | Laparoscopic appendectomy. S group. |
| Hem-o-lok clip | Device | Laparoscopic appendectomy. H group. |
| DS clip | Device | Laparoscopic appendectomy. DS group. |
Primary outcome
Overall Morbidity
Time frame: 30 days
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.
5 secondary outcomes
Intra-perative Complications
Time frame: 120 min.
Postoperative Complications
Time frame: 30 days
Operative Time
Time frame: 120 min.
Time of Application
Time frame: 120 min
Hospital Stay
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We have no plan to share IPD.
Related trials for Appendicitis
RecruitingObservational study
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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
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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.
Enver Zerem, MD, PhD study chair
University Clinical Center Tuzla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E group, S group and H group in people with Appendicitis, run by University Clinical Center Tuzla at 1 site in Bosnia and Herzegovina.
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 1 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 14 Jun 2017. 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 Bosnia and Herzegovina. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Morbidity (time frame: 30 days). 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 14 Jun 2017.