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OpenTrials
Completed

NCT Number: NCT01967745

Laparoscopic Versus Open Appendectomy

Comparison of open and laparoscopic appendectomy

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Key information

Conditions

Acute Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Varazdin General Hospital

Varaždin, 42000, Croatia

About this study

Adult patients with presumptive diagnosis of acute appendicitis were were operated by laparoscopic appendectomy or open appendectomy group during a three-year period (between 2007 and 2009).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients older than 16 years with presumptive diagnosis of acute appendicitis

Exclusion criteria

Appendectomy performed during diagnostic laparoscopy and incidental appendectomies patients with:

  • cirrhosis
  • ascites
  • coagulation disorder
  • diffuse peritonitis
  • shock on admission
  • large ventral hernia. Appendectomy performed during diagnostic laparoscopy and incidental appendectomies were also excluded

Treatment and study plan

laparoscopic appendectomy

Procedure

The laparoscopic appendectomy was performed with three trocars. Pneumoperitoneum was created using an open Hasson technique. The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device. The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel. The specimen was removed through the umbilical port.

Other names: harmonic scalpel (UltraCision Ethicon ®), fusion device (Covidien LigaSure™), stapling device (Covidien Endo GIA™)

open appendectomy

Procedure

The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).

Primary outcomes

  1. Cost of hospitalization based on the final hospital bills

    Time frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)

Secondary outcomes

  1. Analgesia demands

    Time frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)

    The number of doses of analgesics, and time from surgery to the last dose of analgesics.

  2. Complications

    Time frame: during first 4 weeks after the surgery

    No. of wound infection and intrabdominal abscesses.

  3. Length of hospital stay

    Time frame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)

    No. of days from surgery to discharge of hospital

  4. Time until resumption of clear liquid and regular diet

    Time frame: from the beginning of the surgery to the resumption (an expected average 2 days after the surgery)

    No. of days from surgery to the resumption of clear liquid and regular diet

Sponsors and collaborators

Lead sponsor

Varazdin General Hospital

Other

Registry information

Official study title

Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis

Important dates

Study start
2007
Primary completion
2009
Study completion
2013
First posted
Oct 23, 2013
Registry last updated
Oct 24, 2014

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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