Enhanced Recovery After Surgery: A RCT of Perioperative Management of Gynecologic Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | September 2016 |
| Contact: | Kathryn Maurer, MD |
| Email: | maurerk@ccf.org |
| Phone: | 216-444-7645 |
Enhanced Recovery After Surgery: A Randomized Control Trial of Perioperative Management of Gynecologic Patients
This is a single-blinded randomized control trial comparing the current perioperative care
of the investigators gynecologic oncology patients with a standardized perioperative
"enhanced recovery" pathway. Adult patients undergoing laparotomy by one of the gynecologic
oncology surgeons will be eligible to participate. The primary outcome will be length of
hospitalization including any days of readmission in the 30 days post-operatively. Secondary
outcomes will include 30-day readmission rate, complications, quality of recovery, and pain
control.
of the investigators gynecologic oncology patients with a standardized perioperative
"enhanced recovery" pathway. Adult patients undergoing laparotomy by one of the gynecologic
oncology surgeons will be eligible to participate. The primary outcome will be length of
hospitalization including any days of readmission in the 30 days post-operatively. Secondary
outcomes will include 30-day readmission rate, complications, quality of recovery, and pain
control.
The objective of this research is to implement and evaluate an enhanced recovery pathway for
gynecologic surgery patients undergoing laparotomy and compare their outcomes to the current
standard of care perioperative management.
Hypothesis: Patients having a laparotomy for gynecologic disease have a shortened length of
hospitalization in the 30 days post-operatively when undergoing a perioperative enhanced
recovery protocol compared to the standard of care.
This study will be a randomized single-blinded control trial.
Primary Outcomes: Hospital days in first 30 days post-operatively (Length of stay of primary
hospitalization plus any days of readmission)
Secondary Outcomes:
1. 30-day readmission rate
2. Complications as assessed by the incidence of a composite of major complications and a
second composite of minor complications.
3. Patient reported quality of recovery and quality of life as determined by QoR-40 score
and RAND-36 score.
4. Pain control at assessed by daily mean pain scores (scale 0-10) as elicited and
recorded by nursing.
All women who meet inclusion criteria will be approached in the gynecologic oncology clinic
at the completion of their appointment. Eligible patients that agree to participate will be
provided written informed consent. The informed consent process will occur in a clinic exam
room. There will be no other recruitment methods or advertisements employed. Patients can
agree to participate at this time or at any time prior to their pre-operative teaching
appointment which is scheduled at some point between their initial surgical consult visit
and their surgery. The first study intervention will take place at their pre-operative
teaching appointment and so enrollment must occur prior to this time.
Randomization will occur at study entry. The participants will then be randomized to one of
two groups: "standard care" or "enhanced recovery care." Randomization will be stratified by
disease type, age, and BMI. Given the longer length of hospitalization inherent in
ovarian/primary peritoneal cancer debulking surgery, the investigators want to stratify
based on the pre-operative suspected diagnosis in an attempt to balance these patients
between groups. Similarly, advanced age and increased BMI are risks factors for
peri-operative complications and increased length of hospitalizations and should be
stratified between groups. Within each stratum, randomization will be performed in blocks of
8 to ensure that groups are balanced throughout the study in case recruitment goals are not
reached. Two hundred randomization assignments will be assigned to each stratum to ensure
sufficient assignments are available to each group in the event that more patients are
recruited than expected.
Allocation will be revealed to the PI and the surgical team at the time of randomization.
This is necessary because the pre-operative counseling intervention for those patients in
the "enhanced recovery" intervention will need to occur at this time. Allocation will remain
concealed for the patient and for the members of the research team who are conducting the
post-discharge surveys.
Two survey instruments will be used to evaluate pre-operative and post-operative quality of
life as well as quality of recovery. The RAND-36 will be utilized as a pre-operative and 4
week post-operative assessment of health-related quality of life. This 36 item
health-related quality of life instrument includes eight dimensions: general health,
physical functioning, emotional wellbeing, social functioning, energy, pain, and physical
and emotional role functioning. While this is a generic assessment of quality of life and
not designed to be specific to surgical recovery-related quality of life, the investigators
are including this instrument in order to have a baseline health-related quality of life
assessment of the investigators patients and to allow for comparisons to other studies of
perioperative gynecology patients.
The QoR-40 is a 40-question tool used to evaluate the quality of recovery. It incorporates 5
dimensions of health: patient support, comfort, emotions, physical independence, and pain.
The QoR40 is one of the most widely used measurements of patient-determined quality of
recovery. It has been extensively validated and has excellent reliability, responsiveness,
and clinical utility to a range of surgical settings.
Both the RAND-36 and QoR-40 have been used to study post-operative recovery in women
undergoing gynecologic surgery and have been found to be valid. Furthermore, both surveys
have been validated for both self-administration and telephone administration.
Description of Intervention Start of Study Interventions At their pre-operative teaching
appointment, all study participants will be asked to complete a health and quality of life
survey.
Protocol-specific Interventions:
1. "Standard of care" group: Treating physicians will determine all aspects of patients'
perioperative care. Specifically, the individual surgeon, nurse, resident, fellow, and
anesthesiologist caring for the patient will determine the patients' pre-operative
counseling, bowel preparation, postoperative nausea and vomiting prophylaxis, IV fluid
replacement, use of drains, timing of urinary catheter removal, mobilization,
post-operative nutrition, pain medication, and bowel stimulation.
2. "Enhanced recovery" group: Aspects of perioperative care will be standardized in terms
of the pre-operative, intra-operative and post-operative management of issues such as
pre-operative counseling, bowel preparation, postoperative nausea and vomiting
prophylaxis, IV fluid replacement, use of drains, timing of urinary catheter removal,
mobilization, post-operative nutrition, pain medication, and bowel stimulation. Of
note, these interventions have previously been studied in isolation and in combination.
They are considered by many to be the standard perioperative management of surgical
patients
Postoperative Interventions All participants will be surveyed post-surgery regarding their
quality of recovery.
Post-discharge and Over-the-Phone Interventions Participants will be called 4 weeks after
their surgery and asked about any hospital readmissions and complications at this time. They
will also complete post-discharge surveys.
gynecologic surgery patients undergoing laparotomy and compare their outcomes to the current
standard of care perioperative management.
Hypothesis: Patients having a laparotomy for gynecologic disease have a shortened length of
hospitalization in the 30 days post-operatively when undergoing a perioperative enhanced
recovery protocol compared to the standard of care.
This study will be a randomized single-blinded control trial.
Primary Outcomes: Hospital days in first 30 days post-operatively (Length of stay of primary
hospitalization plus any days of readmission)
Secondary Outcomes:
1. 30-day readmission rate
2. Complications as assessed by the incidence of a composite of major complications and a
second composite of minor complications.
3. Patient reported quality of recovery and quality of life as determined by QoR-40 score
and RAND-36 score.
4. Pain control at assessed by daily mean pain scores (scale 0-10) as elicited and
recorded by nursing.
All women who meet inclusion criteria will be approached in the gynecologic oncology clinic
at the completion of their appointment. Eligible patients that agree to participate will be
provided written informed consent. The informed consent process will occur in a clinic exam
room. There will be no other recruitment methods or advertisements employed. Patients can
agree to participate at this time or at any time prior to their pre-operative teaching
appointment which is scheduled at some point between their initial surgical consult visit
and their surgery. The first study intervention will take place at their pre-operative
teaching appointment and so enrollment must occur prior to this time.
Randomization will occur at study entry. The participants will then be randomized to one of
two groups: "standard care" or "enhanced recovery care." Randomization will be stratified by
disease type, age, and BMI. Given the longer length of hospitalization inherent in
ovarian/primary peritoneal cancer debulking surgery, the investigators want to stratify
based on the pre-operative suspected diagnosis in an attempt to balance these patients
between groups. Similarly, advanced age and increased BMI are risks factors for
peri-operative complications and increased length of hospitalizations and should be
stratified between groups. Within each stratum, randomization will be performed in blocks of
8 to ensure that groups are balanced throughout the study in case recruitment goals are not
reached. Two hundred randomization assignments will be assigned to each stratum to ensure
sufficient assignments are available to each group in the event that more patients are
recruited than expected.
Allocation will be revealed to the PI and the surgical team at the time of randomization.
This is necessary because the pre-operative counseling intervention for those patients in
the "enhanced recovery" intervention will need to occur at this time. Allocation will remain
concealed for the patient and for the members of the research team who are conducting the
post-discharge surveys.
Two survey instruments will be used to evaluate pre-operative and post-operative quality of
life as well as quality of recovery. The RAND-36 will be utilized as a pre-operative and 4
week post-operative assessment of health-related quality of life. This 36 item
health-related quality of life instrument includes eight dimensions: general health,
physical functioning, emotional wellbeing, social functioning, energy, pain, and physical
and emotional role functioning. While this is a generic assessment of quality of life and
not designed to be specific to surgical recovery-related quality of life, the investigators
are including this instrument in order to have a baseline health-related quality of life
assessment of the investigators patients and to allow for comparisons to other studies of
perioperative gynecology patients.
The QoR-40 is a 40-question tool used to evaluate the quality of recovery. It incorporates 5
dimensions of health: patient support, comfort, emotions, physical independence, and pain.
The QoR40 is one of the most widely used measurements of patient-determined quality of
recovery. It has been extensively validated and has excellent reliability, responsiveness,
and clinical utility to a range of surgical settings.
Both the RAND-36 and QoR-40 have been used to study post-operative recovery in women
undergoing gynecologic surgery and have been found to be valid. Furthermore, both surveys
have been validated for both self-administration and telephone administration.
Description of Intervention Start of Study Interventions At their pre-operative teaching
appointment, all study participants will be asked to complete a health and quality of life
survey.
Protocol-specific Interventions:
1. "Standard of care" group: Treating physicians will determine all aspects of patients'
perioperative care. Specifically, the individual surgeon, nurse, resident, fellow, and
anesthesiologist caring for the patient will determine the patients' pre-operative
counseling, bowel preparation, postoperative nausea and vomiting prophylaxis, IV fluid
replacement, use of drains, timing of urinary catheter removal, mobilization,
post-operative nutrition, pain medication, and bowel stimulation.
2. "Enhanced recovery" group: Aspects of perioperative care will be standardized in terms
of the pre-operative, intra-operative and post-operative management of issues such as
pre-operative counseling, bowel preparation, postoperative nausea and vomiting
prophylaxis, IV fluid replacement, use of drains, timing of urinary catheter removal,
mobilization, post-operative nutrition, pain medication, and bowel stimulation. Of
note, these interventions have previously been studied in isolation and in combination.
They are considered by many to be the standard perioperative management of surgical
patients
Postoperative Interventions All participants will be surveyed post-surgery regarding their
quality of recovery.
Post-discharge and Over-the-Phone Interventions Participants will be called 4 weeks after
their surgery and asked about any hospital readmissions and complications at this time. They
will also complete post-discharge surveys.
Inclusion Criteria:
- Age ≥ 18, who are to undergo laparotomy
Exclusion Criteria:
- Inability to provide informed consent
- Inability to comprehend written or spoken English
- Immobility as defined by inability to ambulate unassisted
- Patient currently residing in a skilled nursing facility
- ASA physical status 4 or 5
- Planned greater than one night admission to the ICU
- Pregnancy
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