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

NCT ID: NCT04886830

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2021-05-01

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.

Conditions

All Appendectomies Performed During the Designated Period in Single Medical Center

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Appendectomy performed with single endoloop to appendiceal stump

Appendectomy performed with single endoloop for closure of appendiceal stump

laparoscopic appendectomy using a single endoloop for appendiceal stump closure

Intervention Type: PROCEDURE

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

laparoscopic appendectomy using two endoloops for appendiceal stump closure

Intervention Type: PROCEDURE

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

laparoscopic appendectomy using a clip for appendiceal stump closure

Intervention Type: PROCEDURE

laparoscopic appendectomy using an endoclip for appendiceal stump closure before resecting the appendix

Interventions

laparoscopic appendectomy using a single endoloop for appendiceal stump closure

laparoscopic appendectomy using a single endoloop for appendiceal stump closure before resecting the appendix

Intervention Type: PROCEDURE

laparoscopic appendectomy using two endoloops for appendiceal stump closure

laparoscopic appendectomy using a two endoloops for appendiceal stump closure before resecting the appendix

Intervention Type: PROCEDURE

laparoscopic appendectomy using a clip for appendiceal stump closure

laparoscopic appendectomy using an endoclip for appendiceal stump closure before resecting the appendix

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

yaron rudnicki

attending surgeon - surgical ward B, Meir medical center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meir medical center

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

MeirMc - appendiceal stump

Identifier Type: -

Identifier Source: org_study_id