Trial Outcomes & Findings for Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery (NCT NCT01911793)
NCT ID: NCT01911793
Last Updated: 2018-03-07
Results Overview
% of patients tolerating a low residue diet on postoperative day 3 will be assessed
TERMINATED
NA
6 participants
by postoperative day 3( 3rd day after surgery)
2018-03-07
Participant Flow
Participant milestones
| Measure |
Stoma Tube
Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.
|
Standard Stoma
Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Stoma Tube
Stoma tube (18 French) red robinson catheter inserted into stoma at the time of surgery
Stoma Tube: Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.
|
Standard Stoma
Patients will have standard stoma created without insertion of stoma tube. Stoma tube will only be inserted postopertively if the patient is felt to have postopeprative ileus, nausea, vomiting, and decreased stoma output as per standard protocol.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
5
|
Baseline Characteristics
Stoma Tube Decompression and Postoperative Ileus After Major Colorectal Surgery
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: by postoperative day 3( 3rd day after surgery)Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
% of patients tolerating a low residue diet on postoperative day 3 will be assessed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during 30 day postoperative periodPopulation: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
\# of hours after surgery at which point first passage of flatus (gas) into stoma bag
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during 30 day postoperative periodPopulation: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
\# of hours after surgery until the patient passes stool into stoma bag
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 day postoperative periodPopulation: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
postoperative day after surgery which patient was discharged home
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 day postoperative periodPopulation: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 day postoperative periodPopulation: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
any major or minor medical and surgical complications after surgery will be recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 day postoperative periodPopulation: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
insertion of nasogastric tube after surgery will be recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during postoperative hospital admission (30 day period)Population: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
any episodes of vomiting will be recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 day postoperative periodPopulation: Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.
diagnosis of postoperative ileus or bowel obstruction made by attending surgeon based on clinical data including abdominal distention, nausea/vomiting, decreased stom output and radiologic factors
Outcome measures
Outcome data not reported
Adverse Events
Stoma Tube
Standard Stoma
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place