NCT04886830

Surgical Appendiceal Stump Closure - a Comparison Between Surgical Appendiceal Base Closure Methods, and Appendiceal Stump Complications.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• All Appendectomies Performed During the Designated Period in Single Medical Center

Interventions

Type	Name	Description
PROCEDURE	laparoscopic appendectomy using a single endoloop for appendiceal stump closure	laparoscopic appendectomy using a single endoloop for appendiceal stump closure before resecting the appendix
PROCEDURE	laparoscopic appendectomy using two endoloops for appendiceal stump closure	laparoscopic appendectomy using a two endoloops for appendiceal stump closure before resecting the appendix
PROCEDURE	laparoscopic appendectomy using a clip for appendiceal stump closure	laparoscopic appendectomy using an endoclip for appendiceal stump closure before resecting the appendix

Timeline

• Start date: 2010-01-01
• Primary completion: 2020-12-30
• Completion: 2021-05-01
• First posted: 2021-05-14
• Last updated: 2021-05-14

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study