Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06443749 |
Other study ID # |
KAHRAMANMARASKSUGCSTOPUZ1..... |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 2024 |
Est. completion date |
December 2024 |
Study information
Verified date |
May 2024 |
Source |
Kahramanmaras Sutcu Imam University |
Contact |
Sezgin Topuz |
Phone |
+905370252264 |
Email |
sezgintpz[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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)