"Stump-First" Approach in Laparoscopic Appendectomy

March 25, 2025 updated by: Orhan Üreyen, Izmir City Hospital
Objective: This study aims to compare the standard laparoscopic appendectomy with the "Stump-First Approach" technique in patients diagnosed with acute appendicitis in terms of intraoperative and postoperative complications that may occur (injury, intra-abdominal abscess, postoperative fever, and infection parameters).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients were randomly assigned to two groups: Group 1 underwent laparoscopic appendectomy using the standard approach, and Group 2 underwent laparoscopic appendectomy using the Stump-First Approach. Randomization was performed using a specialized computer program. Pregnant women, individuals under 18 years of age, incidental appendectomies, patients with a history of plastron appendicitis, those with malignant pathology results, patients with additional pathologies aside from appendicitis, and those who underwent conventional appendectomy were excluded from the study. All operations were performed under general anesthesia. A single dose of cefazolin (2g, intravenous) was routinely administered as prophylactic antibiotic therapy during anesthesia induction. All surgeries were conducted under the supervision of a surgical specialist with at least five years of experience.

Surgical Technique: For both groups, access to the abdomen was achieved from below the umbilicus, through the use of a Veress needle for patients with no prior abdominal surgery, and through the Hasson technique for those with a history of abdominal surgery; establishing pneumoperitoneum, the abdomen was inserted with an initial 10 mm trocar. Under direct vision with a 30-degree optical aid, a 5 mm trocar was placed in the suprapubic region and a 10mm trocar in the left lower quadrant. The operating table was positioned at 15-20° Trendelenburg and 10-15° left lateral tilt.

In Group 1, as part of the standard approach, the mesoappendix was initially ligated using LigaSure. After visualizing the base of the appendix, two hemoclips were applied on the stump side and one hemoclip on the appendix side. The tissue between was then divided with scissors, and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag.

For Group 2, the cecal appendix was identified, and a window was created at the base of the appendix between the mesoappendix and the appendiceal wall. Two hemoclips were applied on the stump side, and one hemoclip on the appendix side. The tissue between was then divided with scissors. Finally, the mesoappendix was divided using LigaSure and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag. In both groups, the 10 mm trocar insertion site fascia was closed with 0 polyglactin and the skin with 3/0 polypropylene.

The groups were compared in infection status (white blood cell (WBC) count, C-reactive protein (CRP) levels, proportional changes in these parameters, additional antibiotic requirements). The sample size for the study was calculated using the G*Power 3.1 statistical power analysis program. Assuming α=0.05, power (1-β)=0.95, the case-intervention group allocation ratio 1:1, and a high effect size (Cohen's d=0.97) with a two-tailed analysis, the required sample size was determined to be 60 patients, with 30 in each group.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • İzmir City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute appendicitis

Exclusion Criteria:

  • exist of pregnancy, exist of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: underwent laparoscopic appendectomy using the standard approach
In Group 1, as part of the standard approach, the mesoappendix was initially ligated using LigaSure. After visualizing the base of the appendix, two hemoclips were applied on the stump side and one hemoclip on the appendix side. The tissue between was then divided with scissors, and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag.
Procedure: Classic Approach in Laparoscopic Appendectomy
underwent laparoscopic appendectomy using the standard approach
Active Comparator: Group 2 underwent laparoscopic appendectomy using the Stump-First Approach
Group 2, the cecal appendix was identified, and a window was created at the base of the appendix between the mesoappendix and the appendiceal wall. Two hemoclips were applied on the stump side, and one hemoclip on the appendix side. The tissue between was then divided with scissors. Finally, the mesoappendix was divided using LigaSure and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag
Procedure: Stump first Approach in Laparoscopic Appendectomy
Stump first Approach in Laparoscopic Appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants compared in infection status
Time Frame: 1 year
The groups were compared in infection status (WBC, CRP, additional antibiotic requirements)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/05/2023, numbered 2023/61

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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