Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135603
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2005-08-24
Brief Title:
Antibiotic Therapy Versus Appendectomy for Acute Appendicitis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Prospective Randomized Multicentric Trial Comparing AmoxicillinClavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis Two hundred fifty patients will be included in a prospective multicentric randomized trial The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year parietal and abdominal complications and recurrent appendicitis after antibiotic therapy
Detailed Description:
Appendectomy is the most frequent intra-abdominal operation performed accounting for the majority of admissions in a general surgery unit Appendectomy has always been considered the cornerstone in the treatment of acute appendicitisNevertheless the idea of a conservative treatment using antibiotics is not that recent Current practices have proven the efficiency of antibiotic therapy in treating certain infectious abdominal conditions including appendicular mass with or without periappendicular abscess and acute diverticulitis This success has prompted the researchers to consider the exclusive use of antibiotic therapy in the treatment of non complicated appendicitis
In patients with clinical suspicion of acute appendicitis localized abdominal tenderness inflammatory reactionetc a CT scan will be performed to confirm the diagnosis of non complicated appendicitis This diagnosis is confirmed on the CT in the absence of any sign of either localized peritonitis andor perforation extraluminal gas appendicular abscess or phlegmon
After a thorough explanation of this study the patient will be obliged to sign a written consent Patients will be randomly assigned to either one of the two therapeutic modalities an appendectomyor an antibiotic treatment consisting of amoxicillin and clavulanate potassium
This therapy will be continued until the normalisation of leucocytic count and C reactive protein are achieved In order to demonstrate equivalent conclusive results comparing the two treatment modalities the statistical consultant estimated the inclusion of at least 200 patients in the study However after considering the possible loss of a number of patients following their inclusion for a variety of reasons it was decided that a total of 250 patients will be enrolled
Rate of intra abdominal infections in both therapeutic strategies is the first endpoint to be compared Duration of pain diet hospitalisation absence from work will also be compared In the group of patients treated by antibiotics the rate of persistant and recurrent appendicitis after treatment will be evaluated Recurrent appendicitis is not considered a complication as long as the recurrence of the appendicitis is uncomplicated During the followup period of one year long-term complications will be observed including abdominal hernia adhesive intestinal occlusion and others
In patients with clinical suspicion of acute appendicitis localized abdominal tenderness inflammatory reactionetc a CT scan will be performed to confirm the diagnosis of non complicated appendicitis This diagnosis is confirmed on the CT in the absence of any sign of either localized peritonitis andor perforation extraluminal gas appendicular abscess or phlegmon
After a thorough explanation of this study the patient will be obliged to sign a written consent Patients will be randomly assigned to either one of the two therapeutic modalities an appendectomyor an antibiotic treatment consisting of amoxicillin and clavulanate potassium
This therapy will be continued until the normalisation of leucocytic count and C reactive protein are achieved In order to demonstrate equivalent conclusive results comparing the two treatment modalities the statistical consultant estimated the inclusion of at least 200 patients in the study However after considering the possible loss of a number of patients following their inclusion for a variety of reasons it was decided that a total of 250 patients will be enrolled
Rate of intra abdominal infections in both therapeutic strategies is the first endpoint to be compared Duration of pain diet hospitalisation absence from work will also be compared In the group of patients treated by antibiotics the rate of persistant and recurrent appendicitis after treatment will be evaluated Recurrent appendicitis is not considered a complication as long as the recurrence of the appendicitis is uncomplicated During the followup period of one year long-term complications will be observed including abdominal hernia adhesive intestinal occlusion and others
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOR 02063 | None | None | None |