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Completed

NCT Number: NCT06897709

"Stump-First" Approach in Laparoscopic Appendectomy

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).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İzmir City Hospital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute appendicitis

Exclusion criteria

  • exist of pregnancy, exist of cancer

Treatment and study plan

Classic Approach in Laparoscopic Appendectomy

Procedure

underwent laparoscopic appendectomy using the standard approach

Stump first Approach in Laparoscopic Appendectomy

Procedure

Stump first Approach in Laparoscopic Appendectomy

Primary outcomes

  1. The number of participants compared in infection status

    Time frame: 1 year

    The groups were compared in infection status (WBC, CRP, additional antibiotic requirements)

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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