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NCT Number: NCT01007318

Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis

The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.

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Key information

Conditions

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

Age range

7 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyung Hee University School of Medicine, Neo Medical Center

Seoul, 134-727, South Korea

About this study

Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinically diagnosed acute appendicitis

Exclusion criteria

  • Age less than 7 or more than 75 years old
  • Gangrenous appendicitis
  • Combined generalized peritonitis
  • ASA score more than 3 point
  • Pregnant women
  • Cases requiring draining tube

Treatment and study plan

Single port laparoscopic appendectomy

Procedure

Single port through the transumbilical 2-cm incision

Other names: single port laparoscopic surgery

3 port laparoscopic appendectomy

Procedure

3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area

Other names: conventional laparoscopic appendectomy

Primary outcomes

  1. Safety

    Time frame: 1 month

    30 day morbidity and mortality

Secondary outcomes

  1. Efficacy

    Time frame: 1 day

    Operative time

  2. Efficacy

    Time frame: 2 days

    Postoperative pain score

  3. Efficacy

    Time frame: 2 days

    Postoperative functional recovery

  4. Efficacy

    Time frame: 7 days

    Duration of postoperative hospital stay

  5. Efficacy

    Time frame: 7 days

    Cost

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • KyungHee University School of Medicine, Korea

Registry information

Official study title

Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis

Important dates

Study start
2009
Primary completion
2010
Study completion
2016
First posted
Nov 4, 2009
Registry last updated
Sep 7, 2020

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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