Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576533
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2020-09-30
Brief Title:
Patients Undergoing Laparoscopic Colorectal Surgery Walk Out From Operating Room After Surgery WOFOR-C1
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Colorectal Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Early mobilization is considered as an important strategy to enhance postoperative recovery However direct association between very early mobilization and improved recovery needs randomized control trials to prove This study proposes the program of walking out from operating room WOFOR after surgery which means that encouraging patients to walk out from the operating room and return to the ward by walking under the condition of painlessness clear consciousness and normal muscle strength of lower limb The aim of this randomized controlled trial is to investigate the effect of WOFOR on the postoperative recovery of patients undergoing laparoscopic colorectal surgery
Detailed Description:
Postoperative bed rest increases the risk of complications such as thromboembolism and intestinal adhesion Encouraging early mobilization after surgery should be important although actual effects of early mobilization still need randomized control trails to prove The aim of this randomized controlled trial is to investigate the effect of walking out from operating room very early mobilization after surgery on the postoperative recovery of patients undergoing laparoscopic colorectal surgery
A sample size of 300 patients in each group will be selected by a prior power analysis on the basis of the following assumptions 1 an absolute reduction in the length of the hospital stay by 1 day 9 days in intervention group and 8 days in control group 2 standard deviation 3 days 3 α005 4 power 80 and 5 missed follow-up rate 5
Patients will receive written and verbal information about the trial before written consent is obtained The randomization will take place before the day of the surgery and the patients will be assigned to either intervention return to ward by walking or control group return to ward by lying on the transporting bed A stratified randomization with three factors including sexfemale or male tumor site colon or rectum and age 18-40 or 41-65 years old will be performed to ensure an even spread The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician
The patients will receive general anesthesia combined with epidural analgesia After surgery the patients will be evaluated whether fulfilling the criteria for mobilization including stable physiological parameters consciousness normal level of orientation and muscle strength and painlessness every ten minutes If patients fulfill the criteria they will receive different methods of returning to the ward based on the grouping In the control group the patient will return to the ward by lying on the transporting bed In the intervention group the patients will be raised to a sitting position for five minutes If the patients do not complain any discomfort and have stable physiological parameters they will be encouraged to stand If standing do not cause any discomfort they will be encouraged to walk within the range of 5-meter long and 60-centimeter wide If patients can walk within the range they will return to the surgical ward by walking under the protection of medical staffs
Then all study patients will be subject to the same management such as the guidance of drink and diet recovery the guidance of mobilization in the ward the duration and distance of walking in the ward will be recorded every day nutrition supplement after surgery and the criteria of drainage removal and hospital discharge The outcomes such as the length of hospital stay after surgery will be recorded and analyzed to evaluate the effects of walking out from the operating room The analysis of Intention-to-treat and Per-protocol-sets will be both performed by statisticians
Summary statistics of mean SD for normally distributed data or median IQR for skewed data will be generated for continuous variables and frequency percentage will be generated for categorical or ordinal variables Continuous variables will be analyzed by Students t test or Mann-Whitney U test or Repeated Measures Analysis of Variance and categorical outcomes will be analyzed by χ² test
A sample size of 300 patients in each group will be selected by a prior power analysis on the basis of the following assumptions 1 an absolute reduction in the length of the hospital stay by 1 day 9 days in intervention group and 8 days in control group 2 standard deviation 3 days 3 α005 4 power 80 and 5 missed follow-up rate 5
Patients will receive written and verbal information about the trial before written consent is obtained The randomization will take place before the day of the surgery and the patients will be assigned to either intervention return to ward by walking or control group return to ward by lying on the transporting bed A stratified randomization with three factors including sexfemale or male tumor site colon or rectum and age 18-40 or 41-65 years old will be performed to ensure an even spread The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician
The patients will receive general anesthesia combined with epidural analgesia After surgery the patients will be evaluated whether fulfilling the criteria for mobilization including stable physiological parameters consciousness normal level of orientation and muscle strength and painlessness every ten minutes If patients fulfill the criteria they will receive different methods of returning to the ward based on the grouping In the control group the patient will return to the ward by lying on the transporting bed In the intervention group the patients will be raised to a sitting position for five minutes If the patients do not complain any discomfort and have stable physiological parameters they will be encouraged to stand If standing do not cause any discomfort they will be encouraged to walk within the range of 5-meter long and 60-centimeter wide If patients can walk within the range they will return to the surgical ward by walking under the protection of medical staffs
Then all study patients will be subject to the same management such as the guidance of drink and diet recovery the guidance of mobilization in the ward the duration and distance of walking in the ward will be recorded every day nutrition supplement after surgery and the criteria of drainage removal and hospital discharge The outcomes such as the length of hospital stay after surgery will be recorded and analyzed to evaluate the effects of walking out from the operating room The analysis of Intention-to-treat and Per-protocol-sets will be both performed by statisticians
Summary statistics of mean SD for normally distributed data or median IQR for skewed data will be generated for continuous variables and frequency percentage will be generated for categorical or ordinal variables Continuous variables will be analyzed by Students t test or Mann-Whitney U test or Repeated Measures Analysis of Variance and categorical outcomes will be analyzed by χ² test
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