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

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.

Study Overview

• Status: Completed
• Conditions: All Appendectomies Performed During the Designated Period in Single Medical Center
• Intervention / Treatment: Procedure: laparoscopic appendectomy using a single endoloop for appendiceal stump closure; Procedure: laparoscopic appendectomy using two endoloops for appendiceal stump closure; Procedure: laparoscopic appendectomy using a clip for appendiceal stump closure

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 4428139
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Appendectomy performed with single endoloop to appendiceal stump; Appendectomy performed with single endoloop for closure of appendiceal stump	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
Appendectomy performed with two endoloops to appendiceal stump; Appendectomy performed with two endoloops for closure of appendiceal stump	Procedure: laparoscopic appendectomy using two endoloops for appendiceal stump closure; laparoscopic appendectomy using a two endoloops for appendiceal stump closure before resecting the appendix
Appendectomy performed with a clip to appendiceal stump; Appendectomy performed with a clip for closure of appendiceal stump	Procedure: laparoscopic appendectomy using a clip for appendiceal stump closure; laparoscopic appendectomy using an endoclip for appendiceal stump closure before resecting the appendix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	postoperative complications such as abscess formation, perforation, need of second surgery. complications measured with clavien-dindo classification	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
costs of different appendiceal stump closure techniques	costs of different appendiceal stump closure techniques	30 days

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: laparoscopic appendectomy; appendiceal stump; endoloop
• Other Study ID Numbers: MeirMc - appendiceal stump

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes