All Appendectomies Performed During the Designated Period in Single Medical CenterNCT04886830
Surgical Appendiceal Stump Closure - a Comparison Between Surgical Appendiceal Base Closure Methods, and Appendiceal Stump Complications.
An observational study of All Appendectomies Performed During the Designated Period in Single Medical Center, run by Meir Medical Center at 1 site in Israel.
Trial summary
comparing the rate and severity of postoperative complication after LA in regards of different appendiceal stump closure techniques. Data regarding different operative and postoperative parameters was collected from all appendectomies performed in a single medical center in Israel during the years 2010-2020. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- All Appendectomies Performed During the Designated Period in Single Medical Center
- What is being tested?
- laparoscopic appendectomy using a single endoloop for appendiceal stump closure, laparoscopic appendectomy using two endoloops for appendiceal stump closure and laparoscopic appendectomy using a clip for appendiceal stump closure
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2010to 1 May 2021
- Phase
- Observational
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients over the age of 18, who underwent appendectomy between the years 2010-2020
Who may be able to join
- all patients over the age of 18, who underwent appendectomy between the years 2010-2020
Who cannot join
- patients who did not undergo appendectomy patients who underwent appendectomy not using one of the accepted techniques do appendiceal stump closure
Trial locations and contacts
1 site in 1 country.
About this study
comparing the rate and severity of postoperative complication after LA in regards of different appendiceal stump closure techniques. Data regarding different operative and postoperative parameters was collected from all appendectomies performed in a single medical center in Israel during the years 2010-2020.
Read the detailed description
To date, laparoscopic appendectomy (LA) is still the most common surgical procedure done in an acute setting [1,2]. Most patients presenting to the ER with acute appendicitis, will undergo an appendectomy in the same hospital admission [3]. The widely practiced technique for LA, is the placement of access trocars in a proper triangulation, insufflation of the abdomen to create a pneumoperitoneum, dissecting through the mesoappendix with electrothermal devices to expose the appendiceal base, appendiceal stump closure and appendiceal resection, and finally extraction of the resected appendix [4].
There are multiple techniques to close and secure the appendiceal stump. The use of staples, clips and prepared surgical knots such as the ENDOLOOP with PDS suture is widely in use. Although requiring less manual surgical skill to use, the costs of staples and clips are higher than the prepared suture, and the use of larger trocars is obligatory [4].
Yet, data comparing the postoperative efficacy and safety of these appendiceal stump closure techniques is scarce.
The aim of this study is to compare the postoperative efficacy and safety of appendiceal stump closure techniques, and to assess their cost effectiveness.
This is a retrospective, single center study, comparing the rate and severity of postoperative complication after LA. Data regarding different operative and postoperative parameters was collected from all appendectomies performed in a single medical center in Israel during the years 2010-2020.
- Being tested
- laparoscopic appendectomy using a single endoloop for appendiceal stump closure, laparoscopic appendectomy using two endoloops for appendiceal stump closure, laparoscopic appendectomy using a clip for appendiceal stump closure
- Keywords
- laparoscopic appendectomy, appendiceal stump, endoloop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic appendectomy using a single endoloop for appendiceal stump closureProcedure or surgery
laparoscopic appendectomy using a single endoloop for appendiceal stump closure before resecting the appendix
laparoscopic appendectomy using two endoloops for appendiceal stump closureProcedure or surgery
laparoscopic appendectomy using a two endoloops for appendiceal stump closure before resecting the appendix
laparoscopic appendectomy using a clip for appendiceal stump closureProcedure or surgery
laparoscopic appendectomy using an endoclip for appendiceal stump closure before resecting the appendix
| Study group | Role | What they receive |
|---|---|---|
| Appendectomy performed with single endoloop to appendiceal stump | Appendectomy performed with single endoloop for closure of appendiceal stump Receives: Procedure: laparoscopic appendectomy using a single endoloop for appendiceal stump closure | |
| Appendectomy performed with two endoloops to appendiceal stump | Appendectomy performed with two endoloops for closure of appendiceal stump Receives: Procedure: laparoscopic appendectomy using two endoloops for appendiceal stump closure | |
| Appendectomy performed with a clip to appendiceal stump | Appendectomy performed with a clip for closure of appendiceal stump Receives: Procedure: laparoscopic appendectomy using a clip for appendiceal stump closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
postoperative complications such as abscess formation, perforation, need of second surgery. complications measured with clavien-dindo classification
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 posted14 May 2021
- Study start1 Jan 2010
- Primary completion30 Dec 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Appendectomies Performed During the Designated Period in Single Medical CenterStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yaron rudnicki, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886830
- Sponsor's protocol ID
- MeirMc - appendiceal stump
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Appendiceal Stump Closure - a Comparison Between Surgical Appendiceal Base Closure Methods, and Appendiceal Stump Complications.
- ClinicalTrials.gov ID
- NCT04886830
- Acronym / sponsor ID
- MeirMc - appendiceal stump
- Keywords
- laparoscopic appendectomy, appendiceal stump, endoloop
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 14 May 2021 (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.
comparing the rate and severity of postoperative complication after LA in regards of different appendiceal stump closure techniques. Data regarding different operative and postoperative parameters was collected from all appendectomies performed in a single medical center in Israel during the years 2010-2020.
Detailed description
To date, laparoscopic appendectomy (LA) is still the most common surgical procedure done in an acute setting [1,2]. Most patients presenting to the ER with acute appendicitis, will undergo an appendectomy in the same hospital admission [3]. The widely practiced technique for LA, is the placement of access trocars in a proper triangulation, insufflation of the abdomen to create a pneumoperitoneum, dissecting through the mesoappendix with electrothermal devices to expose the appendiceal base, appendiceal stump closure and appendiceal resection, and finally extraction of the resected appendix [4].
There are multiple techniques to close and secure the appendiceal stump. The use of staples, clips and prepared surgical knots such as the ENDOLOOP with PDS suture is widely in use. Although requiring less manual surgical skill to use, the costs of staples and clips are higher than the prepared suture, and the use of larger trocars is obligatory [4].
Yet, data comparing the postoperative efficacy and safety of these appendiceal stump closure techniques is scarce.
The aim of this study is to compare the postoperative efficacy and safety of appendiceal stump closure techniques, and to assess their cost effectiveness.
This is a retrospective, single center study, comparing the rate and severity of postoperative complication after LA. Data regarding different operative and postoperative parameters was collected from all appendectomies performed in a single medical center in Israel during the years 2010-2020.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Appendectomy performed with single endoloop to appendiceal stump | – | Procedure: laparoscopic appendectomy using a single endoloop for appendiceal stump closureAppendectomy performed with single endoloop for closure of appendiceal stump |
| Appendectomy performed with two endoloops to appendiceal stump | – | Procedure: laparoscopic appendectomy using two endoloops for appendiceal stump closureAppendectomy performed with two endoloops for closure of appendiceal stump |
| Appendectomy performed with a clip to appendiceal stump | – | Procedure: laparoscopic appendectomy using a clip for appendiceal stump closureAppendectomy performed with a clip for closure of appendiceal stump |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients over the age of 18, who underwent appendectomy between the years 2010-2020
Key inclusion criteria (1 listed)
- all patients over the age of 18, who underwent appendectomy between the years 2010-2020
Key exclusion criteria (1 listed)
- patients who did not undergo appendectomy patients who underwent appendectomy not using one of the accepted techniques do appendiceal stump closure
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 |
|---|---|---|
| laparoscopic appendectomy using a single endoloop for appendiceal stump closurelaparoscopic appendectomy using a single endoloop for appendiceal stump closure before resecting the appendix | Procedure or surgery | Appendectomy performed with single endoloop to appendiceal stump |
| laparoscopic appendectomy using two endoloops for appendiceal stump closurelaparoscopic appendectomy using a two endoloops for appendiceal stump closure before resecting the appendix | Procedure or surgery | Appendectomy performed with two endoloops to appendiceal stump |
| laparoscopic appendectomy using a clip for appendiceal stump closurelaparoscopic appendectomy using an endoclip for appendiceal stump closure before resecting the appendix | Procedure or surgery | Appendectomy performed with a clip to appendiceal stump |
Primary outcome
postoperative complications
Time frame: 30 days
postoperative complications such as abscess formation, perforation, need of second surgery. complications measured with clavien-dindo classification
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 14 May 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Appendectomies Performed During the Designated Period in Single Medical Center, run by Meir Medical Center at 1 site in Israel.
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 May 2021. 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 Israel. 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?
postoperative complications (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 May 2021.