Closure of the Appendiceal Stump

NCT ID: NCT06443749

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2024-12-31

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)

Conditions

Appendectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group1

the appendiceal stump will be closed with a polyper homologous clip

Group Type: ACTIVE_COMPARATOR

appendectomy

Intervention Type: PROCEDURE

the appendiceal stump will be closed with a polyper homologous clip or with an intracorporial node

group

the stump will be closed with an intracorporial node with a single instrument in

Group Type: ACTIVE_COMPARATOR

appendectomy

Intervention Type: PROCEDURE

the appendiceal stump will be closed with a polyper homologous clip or with an intracorporial node

Interventions

appendectomy

the appendiceal stump will be closed with a polyper homologous clip or with an intracorporial node

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who are diagnosed with acute appendicitis

Exclusion Criteria

• bleeding diathesis
• cirrhotic acid,

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

Sponsors

Sezgin Topuz

OTHER

Sponsor Role: lead

Responsible Party

Sezgin Topuz

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Sezgin Topuz

Role: CONTACT

sezgintpz@gmail.com

+905370252264

Muhammed Alkan

Role: CONTACT

muhammedalkan_@hotmail.com

Other Identifiers

KAHRAMANMARASKSUGCSTOPUZ1.....

Identifier Type: -

Identifier Source: org_study_id