Clinical trial NCT04886830: Surgical Appendiceal Stump Closure - a Comparison Between Surgical Appendiceal Base Closure Methods, and Appendiceal Stump Complications.
Official title: Surgical Appendiceal Stump Closure - a Comparison Between Surgical Appendiceal Base Closure Methods, and Appendiceal Stump Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Appendectomies Performed During the Designated Period in Single Medical Center
Keywords: laparoscopic appendectomy
appendiceal stump
endoloop
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients over the age of 18, who underwent appendectomy between the years 2010-2020

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

all patients over the age of 18, who underwent appendectomy between the years 2010-2020

Exclusion Criteria:

patients who did not undergo appendectomy patients who underwent appendectomy not using one of the accepted techniques do appendiceal stump closure

Primary outcomes:
measure: postoperative complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: costs of different appendiceal stump closure techniques
timeFrame: 30 days
Locations:
city: Kfar Saba
country: Israel
facility: Meir medical center
Study officials:
References: