A Phase 2 interventional study of Laparoscopic appendectomy and Conservative management with percutaneous drainage in Appendicitis and Abdominal Abscess, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-09-23.
Sponsored by Helsinki University Central Hospital · Phase 2, Interventional, and Treatment
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's enrollment of 60 is below the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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).
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.
Time of hospitalization within the first 60 days after randomization
Time frame: Day 60 after randomization
Need of additional interventions
Interventions include percutaneous drainage and operations
Time frame: Within the first 60 days after randomization
Residual abscess
Time frame: On day 7 after randomization
Attempted procedure not successfully performed
In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible.
Time frame: During the first 24 hours after randomization
The number of complications
Any complication occurring within 60 days from randomization. Both medical and surgical complications are included.
Time frame: Within 60 days from randomization
Number recurrent abscesses
Time frame: Within 60 days after randomization
The record gives a start of Jan 2011, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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