Trial Outcomes & Findings for Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection (NCT NCT00606944)

Results Overview

discharge criteria 1. Tolerance of consecutive 3 soft bland diet 2. Unassisted ambulation 3. No necessity of analgesics 4. Afebrile without major complication 5. Willing to discharge

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

at discharge

Results posted on

2012-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group traditional, conventional care group	ERP Group Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
Overall Study STARTED	98	100
Overall Study COMPLETED	98	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=100 Participants traditional, conventional care group	ERP Group n=98 Participants Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation	Total n=198 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants	49 Participants n=7 Participants	107 Participants n=5 Participants
Age, Categorical >=65 years	42 Participants n=5 Participants	49 Participants n=7 Participants	91 Participants n=5 Participants
Age Continuous	61.1 years STANDARD_DEVIATION 11.0 • n=5 Participants	61.5 years STANDARD_DEVIATION 10.9 • n=7 Participants	61.3 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	36 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	62 Participants n=7 Participants	120 Participants n=5 Participants
Region of Enrollment Korea, Republic of	100 participants n=5 Participants	98 participants n=7 Participants	198 participants n=5 Participants

PRIMARY outcome

Timeframe: at discharge

Population: 1 mortality case was excluded for analysis in the ERP group

discharge criteria 1. Tolerance of consecutive 3 soft bland diet 2. Unassisted ambulation 3. No necessity of analgesics 4. Afebrile without major complication 5. Willing to discharge

Outcome measures

Outcome measures
Measure	Control Group n=100 Participants traditional, conventional care group	ERP Group n=97 Participants Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
the Length of Hospital Stay	8 day Interval 7.0 to 9.0	7 day Interval 6.75 to 8.25

PRIMARY outcome

Timeframe: at discharge

score measured by the Visual Analog Scale

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at discharge

measured by SF-36

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at discharge

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at discharge

recovery criteria must include all of the following 1. Tolerance of consecutive 3 soft bland diet 2. Unassisted ambulation 3. No necessity of analgesics 4. Afebrile without major complication

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at postoperative day 30

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at postoperative day 30

score measured by the Visual Analog Scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at postoperative day 30

measured by SF-36

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at postoperative day 30

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

ERP Group

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=100 participants at risk traditional, conventional care group	ERP Group n=98 participants at risk Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
Gastrointestinal disorders Death	0.00% 0/100	1.0% 1/98 • Number of events 1

Other adverse events

Other adverse events
Measure	Control Group n=100 participants at risk traditional, conventional care group	ERP Group n=98 participants at risk Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
Gastrointestinal disorders Ileus	7.0% 7/100 • Number of events 7	17.3% 17/98 • Number of events 17
Renal and urinary disorders Urinary retention	5.0% 5/100 • Number of events 5	9.2% 9/98 • Number of events 9
Gastrointestinal disorders Chylous ascites	5.0% 5/100 • Number of events 5	6.1% 6/98 • Number of events 6

Additional Information

Sung-Bum Kang

Seoul National University Bundang Hospital

Phone: +82-31-787-7093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place