Laparoscopic Management of Periappendicular Abscess

Appendicitis Clinical Trial

Official title:

Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283815
• Other study ID #: HUSOper193
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2011
• Last updated: September 21, 2014
• Start date: January 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Abscess
• Abscess
• Appendicitis

Intervention

Procedure:
• Laparoscopic appendectomy
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
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.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Meilahti Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of hospitalization within the first 60 days after randomization		Day 60 after randomization	No
Secondary	Need of additional interventions	Interventions include percutaneous drainage and operations	Within the first 60 days after randomization	Yes
Secondary	Residual abscess		On day 7 after randomization	No
Secondary	Attempted procedure not successfully performed	In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible.	During the first 24 hours after randomization	No
Secondary	The number of complications	Any complication occurring within 60 days from randomization. Both medical and surgical complications are included.	Within 60 days from randomization	Yes
Secondary	Number recurrent abscesses		Within 60 days after randomization	No