Closure of the Appendiceal Stump

Appendectomy Clinical Trial

Official title:

Closure of the Appendiceal Stump With a Polymer Clip Versus Intracorporeal Ligation With a Single Instrument in Laparoscopic Appendectomy; Prospective Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443749
• Other study ID #: KAHRAMANMARASKSUGCSTOPUZ1.....
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patients who are diagnosed with acute appendicitis

Exclusion Criteria:

• bleeding diathesis

• cirrhotic acid,

Related Conditions & MeSH terms

• Appendectomy

Intervention

Procedure:
• appendectomy
the appendiceal stump will be closed with a polyper homologous clip or with an intracorporial node

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sezgin Topuz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	operation time	3 months