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OpenTrials
Completed

NCT Number: NCT04886830

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir medical center

Kfar Saba, 4428139, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic appendectomy using a single endoloop for appendiceal stump closure

Procedure

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

laparoscopic appendectomy using two endoloops for appendiceal stump closure

Procedure

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

laparoscopic appendectomy using a clip for appendiceal stump closure

Procedure

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

Primary outcomes

  1. postoperative complications

    Time frame: 30 days

    postoperative complications such as abscess formation, perforation, need of second surgery. complications measured with clavien-dindo classification

Other outcomes

  1. costs of different appendiceal stump closure techniques

    Time frame: 30 days

    costs of different appendiceal stump closure techniques

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2021
First posted
May 14, 2021
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.