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NCT Number: NCT01816568

The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy

Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study the investigators aimed to compare results of SILS appendectomy and three port conventional laparoscopic appendectomy prospectively.

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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

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Total of 50 patients who undergoing laparoscopic appendectomy for acute appendicitis will randomly assign to undergo SILS appendectomy group (n = 25) or Three port laparoscopic appendectomy group (n= 25) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, need for conversion to a standard or three port laparoscopic appendectomy, need for conversion to an open appendectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of colonic leak, wound infection, intrabdominal abscess hospital readmission, and hernia.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion criteria

  • American Society of Anesthesiologists score (ASA) more than III,
  • Patients had prior abdominal surgery,
  • Pregnancy,
  • Ongoing peritoneal dialysis,
  • Lack of written informed consent.

Treatment and study plan

SILS appendectomy

Procedure

Single incision laparoscopic appendectomy will be performed

Three port laparoscopic appendectomy

Procedure

Three port laparoscopic appendectomy will be performed

Primary outcomes

  1. Pain score

    Time frame: Postoperative first 24 hours

    Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.

Secondary outcomes

  1. Intraoperative complications

    Time frame: Average of 50 minutes

    Per operative complications will be recorded.

    • Bleeding
    • Iatrogenic injury
    • Bowel perforation
    • Complications associated with increased intra-abdominal pressure

  2. Operating time

    Time frame: Average of 50 minutes

    The operating time will be defined as the time from the first incision to the last suture's placement.

  3. Postoperative complications

    Time frame: 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year

    Postoperative complications will be recorded postoperative follow up.

    • Bleeding
    • Fecal leakage
    • Intrabdominal injury
    • Wound infection
    • Port site hernia

Other outcomes

  1. Length of hospital stay

    Time frame: Average of 2 days

    Length of hospital stay will be recorded postoperative period.

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2013
Registry last updated
Mar 22, 2013

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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