Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04890015
Status:
UNKNOWN
Last Update Posted:
2021-09-02
First Post:
2021-05-12
Brief Title:
The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis A Randomized Trial
Sponsor:
Institut dInvestigació Biomèdica de Girona Dr Josep Trueta
Organization:
Institut dInvestigació Biomèdica de Girona Dr Josep Trueta
Study Overview
Official Title:
The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis A Randomized and Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
SONDES
Brief Summary:
There is currently no standardization in the use of the transanal decompressive tube during the postoperative after a colorectal surgery The available evidence is based on studies with methodological differences Most of the studies exclude patients with a diverting ileostomy which are those patients who have a higher risk of anastomotic leak so the real effect of transanal decompressive tube could have been masked For this reason we believe that to assess the true effect of rectal decompression patients with diverting stoma should be included
Detailed Description:
One of the complications of performing the colorectal anastomosis is the anastomotic leak which sometimes entails the need for reinterventions and stoma formation provisional or definitive In recent decades the improvement in surgical techniques together with the knowledge of the causes that predispose to the anastomotic failure have allowed to reduced the rates
The placement of a tube probe through the anus in the postoperative period that decompresses the contents of the interior of the intestine liquid or air has been proposed as a factor that could influence the healing between intestines
In studies carried out in other centers with the same characteristics as the present one differences have been shown in the probability of anastomotic leakage but these results are not conclusive and do not allow us to know the effectiveness of this procedure
The placement of a tube probe through the anus in the postoperative period that decompresses the contents of the interior of the intestine liquid or air has been proposed as a factor that could influence the healing between intestines
In studies carried out in other centers with the same characteristics as the present one differences have been shown in the probability of anastomotic leakage but these results are not conclusive and do not allow us to know the effectiveness of this procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None