Skip to main content
OpenTrials
Completed

NCT Number: NCT01283815

Laparoscopic Management of Periappendicular Abscess

According to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not possible because of anatomical position of the abscess and surgical treatment is needed. The purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the first-line treatment in patients with periappendicular abscess.

The hypothesis of the study is that laparoscopic management of periappendicular abscess is suitable for the first-line treatment and it does not increase time of hospitalization or complication rate compared with conservative management.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Appendicitis Abdominal Abscess Abscess Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Suppuration

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Helsinki University Central Hospital, Meilahti Hospital

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Periappendicular abscess at least 2 cm in size

Exclusion criteria

  • Missing written informed consent
  • Antimicrobial therapy lasted over 24 hours before randomization
  • Attempt of drainage before randomization
  • Age over 80 years or under 18 years old
  • Pregnancy
  • Allergy to either Cefuroxime or Metronidazole
  • Severe chronic disease, that substantially increases the risk for operative mortality
  • Previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions
  • Carrier of a resistant bacterial strain
  • Being institutionalized or hospitalized for at least 2 weeks before randomization

Treatment and study plan

laparoscopic appendectomy

Procedure

Laparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group (intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day).

Conservative management with percutaneous drainage

Procedure

Patients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed.

Primary outcomes

  1. Time of hospitalization within the first 60 days after randomization

    Time frame: Day 60 after randomization

Secondary outcomes

  1. Need of additional interventions

    Time frame: Within the first 60 days after randomization

    Interventions include percutaneous drainage and operations

  2. Residual abscess

    Time frame: On day 7 after randomization

  3. Attempted procedure not successfully performed

    Time frame: During the first 24 hours after randomization

    In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible.

  4. The number of complications

    Time frame: Within 60 days from randomization

    Any complication occurring within 60 days from randomization. Both medical and surgical complications are included.

  5. Number recurrent abscesses

    Time frame: Within 60 days after randomization

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2011
Registry last updated
Sep 23, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.