Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443749
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-12-11
Brief Title:
Closure of the Appendiceal Stump
Sponsor:
Sezgin Topuz
Organization:
Kahramanmaras Sutcu Imam University
Study Overview
Official Title:
Closure of the Appendiceal Stump With a Polymer Clip Versus Intracorporeal Ligation With a Single Instrument in Laparoscopic Appendectomy Prospective Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Laparoscopic appendectomy is a well-defined surgical technique However concerns remain about whether closure of the appendiceal stump should be done with clips endoloops staples or other techniques If tying is to be used in the closure of the appendiceal stump there is no consensus on which technique intracorporoyal extracorporoyal etc should be used for ligation For this reason there is a need for studies on different binding techniques and instruments currently used The aim of this study was to compare the use of unilateral intracorporeal knot and polymer endoclip closure during laparoscopic appendectomy
Detailed Description:
Patients who are scheduled to undergo laparoscopic appendectomy after the ethics committee approval will be included consecutively Patients will be randomized into 2 groups those who will be closed with a polymer endoclip Group 1 and those who will be closed with an intracorporeal node with a single instrument Group 2 Data such as age gender body mass index comorbidities previous abdominal surgeries medications used by the patients as well as the presence of ileus perforation and diffuse peritonitis will be recorded After laparoscopic dissection the appendiceal stump will be closed with a polyper homologous clip in Group 1 and the stump will be closed with an intracorporial node with a single instrument in Group 2 The operation times of the patients the time elapsed after the end of the dissection until the pathology specimen comes out of the skin to be determined as the closure time complications such as ileus intra-abdominal abscess bleeding and fistula related to stump closure problems encountered in the postoperative period will be recorded and compared Patients will be followed by the corresponding author In both surgical methods it is routinely used to close the appendiceal stump and in the polymer clip application a clip with a locking mechanism is used when the stump is tightened with an applicator In the intracorporial node with one hand the surgical node is made by circulating the tip of the suture material around the appendix with a single instrument the other end is kept fixed outside the abdomen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None