Laparoscopic Management of Periappendicular Abscess

NCT01283815 | Completed Phase 2

• 1 other identifier: HUSOper193
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Appendicitis; Abdominal Abscess

Keywords

Laparoscopy; Drainage; Appendectomy

Outcome Measures

Primary Outcomes (1)

• Time of hospitalization within the first 60 days after randomization

  Day 60 after randomization

Secondary Outcomes (5)

• Need of additional interventions

  Within the first 60 days after randomization

• Residual abscess

  On day 7 after randomization

• Attempted procedure not successfully performed

  During the first 24 hours after randomization

• The number of complications

  Within 60 days from randomization

• Number recurrent abscesses

  Within 60 days after randomization

Study Arms (2)

Conservative management

ACTIVE COMPARATOR

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.

Procedure: Conservative management with percutaneous drainage

Laparoscopic appendectomy

EXPERIMENTAL

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

Procedure: Laparoscopic appendectomy

Interventions

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).

Laparoscopic appendectomy

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.

Conservative management

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periappendicular abscess at least 2 cm in size

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital, Meilahti Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Appendicitis; Abdominal Abscess

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Abscess; Suppuration

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Panu Mentula, M.D. Ph.D.

  Department of Gastrointestinal Surgery, Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 23, 2014

Record last verified: 2014-09

Locations

FI (1)