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OpenTrials
Completed

NCT Number: NCT01260064

Open Appendectomy Versus Laparoscopic Appendectomy

1. Laparoscopic appendectomy may not be a superior procedure when compared with open appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

About this study

The study will be a prospective randomized clinical trial. Totally 150 patients who are diagnosed to have acute appendicitis will be randomly divided into 3 equal groups (n=50 for each group). First group will have traditional open appendectomy procedure; second group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by metal endoclips; and third group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by intracorporeal suture ligation. The preoperative parameters that will be obtained for all patients are: detailed information for communication, patient history, age, gender, the presence of spesific symptoms (nausea, vomiting, loss of appetite, right lower quadrant pain), the presence of clinical signs, laboratory findings, and radiological findings. The peroperative parameters that will be recorded are: operative time, the type and the length of incisions, the number of trocars, operative findings, details of laparoscopic technique, generic name of prophylactic antibiotic, and the presence of additional findings. All of the patients will undergo a clinical evaluation by attending surgeon on the 5th, the 15th, and the 30th postoperative day. The postoperative clinical evaluation will include the examination of the patient for surgical site infection and other wound complications, and the performance of a spesific quality-of-life index questionnaire. In the end of the study, all parameters and quality-of-life scores will undergo statistical analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patients with a preoperative diagnosis of acute appendicitis

Exclusion criteria

  • The patients who are not volunteered to join the study
  • The patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis
  • The patients who have additional pathologies accompanying acute appendicitis

Treatment and study plan

open appendectomy

Procedure

The subjects will have traditional open appendectomy procedure.

Other names: Open technique

Laparoscopic appendectomy with metal endoclips

Procedure

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.

Other names: Metal endoclip

Laparoscopic appendectomy with suture ligation

Procedure

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.

Other names: Intracorporeal suture ligation

Primary outcomes

  1. Quality of life.

    Time frame: 1 month

    Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.

Secondary outcomes

  1. Cost-effectivity

    Time frame: 1 month

    The study will reveal which procedure for appendectomy is the most cost-effective one.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

The Outcomes of Various Appendectomy Techniques in a High-volume Center.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2010
Registry last updated
May 26, 2011

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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