CClinicalTrials.gg
Not yet recruitingNCT06443749Updated Jun 5, 2024

Closure of the Appendiceal Stump

An interventional study of appendectomy in Appendectomy, sponsored by Sezgin Topuz. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Sezgin Topuz · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Appendectomy

Keywords

  • Appendectomy
03

In context

Lead sponsor

This is the only study on the registry with Sezgin Topuz as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are diagnosed with acute appendicitis

Exclusion criteria

Exclusion Criteria:

  • bleeding diathesis
  • cirrhotic acid,
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    group1

    the appendiceal stump will be closed with a polyper homologous clip

    Procedure: appendectomy

  • Active comparator
    group

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

    Procedure: appendectomy

Interventions

  • Procedureappendectomy

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

06

What researchers measure

Primary outcomes

  1. operation time

    operation time

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06443749
Lead sponsor
Sezgin Topuz
Responsible party
Sezgin Topuz (assistant professor, Kahramanmaras Sutcu Imam University) — Sponsor-investigator
First posted
Jun 5, 2024
Start date
Aug 2024 (estimated)
Primary completion
Nov 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Jun 5, 2024

Study contacts

Sezgin Topuz
Contact
sezgintpz@gmail.com
+905370252264
Muhammed Alkan
Contact
muhammedalkan_@hotmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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