Does Chewing Gum After Elective Laparoscopic Colectomy Surgery Decrease Ileus?
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 2/7/2015 |
| Start Date: | December 2007 |
| End Date: | December 2011 |
| Contact: | Melanie Kalman, RN, PhD |
| Email: | kalmanm@upstate.edu |
| Phone: | 315-464-3909 |
The incidence of ileus after laparoscopic colectomy continues to pose complications for the
patient, staff, and the healthcare system. Postoperative ileus remains a source of morbidity
and a major determinant of length of stay after abdominal surgery. Clinicians have devised
strategies that minimize postoperative ileus. Gum chewing, an inexpensive intervention, is
theorized to activate the cephalic- vagal reflex and increase the production of
gastrointestinal hormones associated with bowel motility. Four studies examining gum chewing
as an intervention to prevent ileus were found. These relatively few studies have
demonstrated inconsistencies. Because of the small sample size of the four studies and the
inconsistencies of the results, there is not enough evidence to change practice. There are
no indications of risks associated with gum chewing as an adjunct therapy along with
standard postoperative interventions. The purpose of this prospective, randomized control
study is to examine if chewing gum in adult patients after elective laparoscopic colectomy
decreases ileus compared with standard post-operative care.
Patients will be randomized by weeks admitted and the patients in the gum chewing group
(intervention group) will chew one stick of gum the first post-operative day, after the
nasogastric tube is removed or if they patient does not have a nasogastric tube, with the
head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set
intervals: 0900, 1400, and 2100. The gum will be kept in the Accudose cabinet and
distributed by the medication nurse. The gum chewing regimen will continue until the first
bowel movement. All patients in the non-intervention group will receive standard
preoperative and postoperative regimens.
Patient demographics that will be collected include gender, age, current medical condition,
pre-operative medications, type of surgery, operative duration in minutes, anesthesia
duration in minutes, estimated operative blood loss, whether they had an epidural or a PCA,
date and time nasogastric tube was discontinued, length of stay, date of discharge,
complications, and whether or not they had an ileus. Patients (if appropriate) and nurses
will be instructed on how to complete the bedside bowel record to the nearest hour.
patient, staff, and the healthcare system. Postoperative ileus remains a source of morbidity
and a major determinant of length of stay after abdominal surgery. Clinicians have devised
strategies that minimize postoperative ileus. Gum chewing, an inexpensive intervention, is
theorized to activate the cephalic- vagal reflex and increase the production of
gastrointestinal hormones associated with bowel motility. Four studies examining gum chewing
as an intervention to prevent ileus were found. These relatively few studies have
demonstrated inconsistencies. Because of the small sample size of the four studies and the
inconsistencies of the results, there is not enough evidence to change practice. There are
no indications of risks associated with gum chewing as an adjunct therapy along with
standard postoperative interventions. The purpose of this prospective, randomized control
study is to examine if chewing gum in adult patients after elective laparoscopic colectomy
decreases ileus compared with standard post-operative care.
Patients will be randomized by weeks admitted and the patients in the gum chewing group
(intervention group) will chew one stick of gum the first post-operative day, after the
nasogastric tube is removed or if they patient does not have a nasogastric tube, with the
head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set
intervals: 0900, 1400, and 2100. The gum will be kept in the Accudose cabinet and
distributed by the medication nurse. The gum chewing regimen will continue until the first
bowel movement. All patients in the non-intervention group will receive standard
preoperative and postoperative regimens.
Patient demographics that will be collected include gender, age, current medical condition,
pre-operative medications, type of surgery, operative duration in minutes, anesthesia
duration in minutes, estimated operative blood loss, whether they had an epidural or a PCA,
date and time nasogastric tube was discontinued, length of stay, date of discharge,
complications, and whether or not they had an ileus. Patients (if appropriate) and nurses
will be instructed on how to complete the bedside bowel record to the nearest hour.
Postoperative ileus remains a source of morbidity and a major determinant of length of stay
after abdominal surgery. This unfortunate complication may certainly affect patient's
satisfaction with their postoperative course. The postoperative care of a laparoscopic
colectomy patient includes interventions that are evidence-based. Despite the evidence-based
interventions, the incidence of ileus after laparoscopic colectomy continues to pose
complications for the patient, staff, and the healthcare system. In the time period from
January 1, 2006 to November 30, 2006 there were a total of 172 laparoscopic colectomies at
St. Joseph's Hospital and 28 patients developed an ileus. Six percent of colectomy patients'
recovery was altered by a prolonged ileus. This is comparably and slightly less then the
National Veterans Affairs Surgical Quality Improvement Program's data for postoperative
ileus of 7.5 % (Longo et al. 2000). However, the length of stay for patients with an ileus
was 8.4 days greater then non ileus patients, with a significant increased cost per ileus
patient of $15,422.86. Clinicians have devised strategies that minimize postoperative ileus.
Adjunct therapies such as motility agents, early postoperative feeding regimens, and
physical therapy have been tested in clinical trials, but are not routinely used because of
their limited clinical efficacy (Matros, et al. 2006). Gum chewing, an inexpensive
intervention, is theorized to activate the cephalic- vagal reflex, which is usually
activated by food, and to increase the production of gastrointestinal hormones associated
with bowel motility (Asao, et al, 2002).
Four studies examining gum chewing as an intervention to prevent ileus were found. These
relatively few studies with a sample of postoperative abdominal surgical patients have
demonstrated inconsistencies. Two studies found that the chewing gum group passed flatus and
had a bowel movement sooner than the control group. One of these studies found a decreased
length of stay. Two other randomized control studies found no statistical significance
between the gum chewing and control groups as far as post-operative ileus or length of stay.
Because of the small sample size of the four studies and the inconsistencies of the results,
there is not enough evidence to change practice. The inexpensive method of gum chewing may
be useful to decrease ileus in post-operative colectomy patients, which will decrease costs
and length of stay. It could also decrease pain, emesis, and morbidity for patients. There
are no indications of risks associated with gum chewing as an adjunct therapy along with
standard postoperative interventions.
SPECIFIC OBJECTIVES: In adult elective laparoscopic colectomy patients does chewing gum
decrease ileus compared with standard post-operative care? STUDY DESIGN: A prospective,
randomized control design
SUBJECT SELECTION: (Include inclusion/exclusion criteria) All participants will be recruited
at St. Joseph's Hospital. The sample will consist of all patients who are 18 years of age
and older and are identified as adults on admission, and/or pre-admission for elective
laparoscopic colectomy surgery. Inclusion criteria consist of all patients admitted to one
surgical unit (3-1) from November 1, 2007 to August 1, 2008 with a non- emergent
laparoscopic colectomy. Exclusion criteria consist of all patients with a history of
metastatic disease, history of inflammatory bowel disease, abdominal radiation treatment,
mint allergy (the gum is mint flavored), dentures, nasogastric tube drainage beyond the
first postoperative morning, more then one bowel anastomosis during this surgery, conversion
to pen colectomy, or admission to an ICI post-operatively.
STATISTICAL METHODS, DATA ANALYSIS AND INTERPRETATION: (Include the factors considered in
determining an appropriate sample size) Data will be analyzed statistically. Descriptive
statistics will be used to describe the entire sample, appropriate to the level of
measurement of each. Independent t-tests for variables measured at ordinal or interval/ratio
levels and chi-square for dichotomous variables will be used to compare the two groups on
all demographic variables, hours since first flatus, and first bowel movement Analysis of
co-variance may be used to statistically control for medical conditions found in the sample
that were not excluded but could affect the findings.
STUDY PROCEDURES: (Describe all study methods chronologically. Distinguish clearly between
treatment-related (standard care) and study-related procedures the subject will undergo).
NOTE: If the proposal includes genetic testing, some information about the genetic testing
must be included. Please provide the following: 1. The type of study planned, 2. What genes
are the investigators looking for, if known, 3. Why the genetic testing is being done (i.e.,
how it is relevant to the overall protocol), and 4. Where the work will be done.
After approval from St Joseph's IRB and SUNY Upstate's IRB, elective laparoscopic colectomy
patients will be identified by the participating surgeons. At the time of preoperative
instructions, a letter will be given or sent to the identified patient explaining the study
(Appendix C). The day of pre-admission testing, the patient will be contacted by a study
team member to review the study and will be asked to participate. If they agree, consent
will be signed and the subjects will be assigned a number to ensure confidentiality.
The sample size of 50 will be randomized in block format, utilizing the weeks by number. The
38 weeks will be placed in a box; the first 19 weeks selected will be the gum chewing group,
the second 19 weeks selected will be the non chewing group.
Each participant in the study will be educated to report to the nurse or self report on the
bed side bowel report sheet the exact time to the hour that flatus is passed and the first
bowel movement. The nursing staff on 3-1 will be instructed and monitored about
documentation of gum chewing, first flatus to the nearest hour, and first bowel movement to
the nearest hour. The data collection form will be completed. The length of the patients
stay will be generated on discharge.
The patients in the gum chewing group (intervention group) will chew one stick of gum the
first post-operative day, after the nasogastric tube is removed or if they patient does not
have a nasogastric tube, with the head of bed elevated a minimum of 30 degrees for 30
minutes, three times a day at set intervals: 0900, 1400, and 2100. Sugar-free gum was used
in all previous studies. Therefore, sugar free gum (Orbit Spearmint Sugarless Gum) will be
used in this study. The gum will be kept in the Accudose cabinet and distributed by the
medication nurse. The gum chewing regimen will continue until the first bowel movement. All
patients in the non-intervention group will receive the standard preoperative and
postoperative regimens. Patient demographics that will be collected include gender, age,
current medical condition, pre-operative medications, type of surgery, operative duration in
minutes, time left OR, anesthesia duration in minutes, estimated operative blood loss,
whether the patient had an epidural or a PCA, date and time nasogastric tube was
discontinued, length of stay, date of discharge, complications, and post-operative ileus.
Patients and nurses will be instructed on how to complete the bedside bowel record to the
nearest hour.
after abdominal surgery. This unfortunate complication may certainly affect patient's
satisfaction with their postoperative course. The postoperative care of a laparoscopic
colectomy patient includes interventions that are evidence-based. Despite the evidence-based
interventions, the incidence of ileus after laparoscopic colectomy continues to pose
complications for the patient, staff, and the healthcare system. In the time period from
January 1, 2006 to November 30, 2006 there were a total of 172 laparoscopic colectomies at
St. Joseph's Hospital and 28 patients developed an ileus. Six percent of colectomy patients'
recovery was altered by a prolonged ileus. This is comparably and slightly less then the
National Veterans Affairs Surgical Quality Improvement Program's data for postoperative
ileus of 7.5 % (Longo et al. 2000). However, the length of stay for patients with an ileus
was 8.4 days greater then non ileus patients, with a significant increased cost per ileus
patient of $15,422.86. Clinicians have devised strategies that minimize postoperative ileus.
Adjunct therapies such as motility agents, early postoperative feeding regimens, and
physical therapy have been tested in clinical trials, but are not routinely used because of
their limited clinical efficacy (Matros, et al. 2006). Gum chewing, an inexpensive
intervention, is theorized to activate the cephalic- vagal reflex, which is usually
activated by food, and to increase the production of gastrointestinal hormones associated
with bowel motility (Asao, et al, 2002).
Four studies examining gum chewing as an intervention to prevent ileus were found. These
relatively few studies with a sample of postoperative abdominal surgical patients have
demonstrated inconsistencies. Two studies found that the chewing gum group passed flatus and
had a bowel movement sooner than the control group. One of these studies found a decreased
length of stay. Two other randomized control studies found no statistical significance
between the gum chewing and control groups as far as post-operative ileus or length of stay.
Because of the small sample size of the four studies and the inconsistencies of the results,
there is not enough evidence to change practice. The inexpensive method of gum chewing may
be useful to decrease ileus in post-operative colectomy patients, which will decrease costs
and length of stay. It could also decrease pain, emesis, and morbidity for patients. There
are no indications of risks associated with gum chewing as an adjunct therapy along with
standard postoperative interventions.
SPECIFIC OBJECTIVES: In adult elective laparoscopic colectomy patients does chewing gum
decrease ileus compared with standard post-operative care? STUDY DESIGN: A prospective,
randomized control design
SUBJECT SELECTION: (Include inclusion/exclusion criteria) All participants will be recruited
at St. Joseph's Hospital. The sample will consist of all patients who are 18 years of age
and older and are identified as adults on admission, and/or pre-admission for elective
laparoscopic colectomy surgery. Inclusion criteria consist of all patients admitted to one
surgical unit (3-1) from November 1, 2007 to August 1, 2008 with a non- emergent
laparoscopic colectomy. Exclusion criteria consist of all patients with a history of
metastatic disease, history of inflammatory bowel disease, abdominal radiation treatment,
mint allergy (the gum is mint flavored), dentures, nasogastric tube drainage beyond the
first postoperative morning, more then one bowel anastomosis during this surgery, conversion
to pen colectomy, or admission to an ICI post-operatively.
STATISTICAL METHODS, DATA ANALYSIS AND INTERPRETATION: (Include the factors considered in
determining an appropriate sample size) Data will be analyzed statistically. Descriptive
statistics will be used to describe the entire sample, appropriate to the level of
measurement of each. Independent t-tests for variables measured at ordinal or interval/ratio
levels and chi-square for dichotomous variables will be used to compare the two groups on
all demographic variables, hours since first flatus, and first bowel movement Analysis of
co-variance may be used to statistically control for medical conditions found in the sample
that were not excluded but could affect the findings.
STUDY PROCEDURES: (Describe all study methods chronologically. Distinguish clearly between
treatment-related (standard care) and study-related procedures the subject will undergo).
NOTE: If the proposal includes genetic testing, some information about the genetic testing
must be included. Please provide the following: 1. The type of study planned, 2. What genes
are the investigators looking for, if known, 3. Why the genetic testing is being done (i.e.,
how it is relevant to the overall protocol), and 4. Where the work will be done.
After approval from St Joseph's IRB and SUNY Upstate's IRB, elective laparoscopic colectomy
patients will be identified by the participating surgeons. At the time of preoperative
instructions, a letter will be given or sent to the identified patient explaining the study
(Appendix C). The day of pre-admission testing, the patient will be contacted by a study
team member to review the study and will be asked to participate. If they agree, consent
will be signed and the subjects will be assigned a number to ensure confidentiality.
The sample size of 50 will be randomized in block format, utilizing the weeks by number. The
38 weeks will be placed in a box; the first 19 weeks selected will be the gum chewing group,
the second 19 weeks selected will be the non chewing group.
Each participant in the study will be educated to report to the nurse or self report on the
bed side bowel report sheet the exact time to the hour that flatus is passed and the first
bowel movement. The nursing staff on 3-1 will be instructed and monitored about
documentation of gum chewing, first flatus to the nearest hour, and first bowel movement to
the nearest hour. The data collection form will be completed. The length of the patients
stay will be generated on discharge.
The patients in the gum chewing group (intervention group) will chew one stick of gum the
first post-operative day, after the nasogastric tube is removed or if they patient does not
have a nasogastric tube, with the head of bed elevated a minimum of 30 degrees for 30
minutes, three times a day at set intervals: 0900, 1400, and 2100. Sugar-free gum was used
in all previous studies. Therefore, sugar free gum (Orbit Spearmint Sugarless Gum) will be
used in this study. The gum will be kept in the Accudose cabinet and distributed by the
medication nurse. The gum chewing regimen will continue until the first bowel movement. All
patients in the non-intervention group will receive the standard preoperative and
postoperative regimens. Patient demographics that will be collected include gender, age,
current medical condition, pre-operative medications, type of surgery, operative duration in
minutes, time left OR, anesthesia duration in minutes, estimated operative blood loss,
whether the patient had an epidural or a PCA, date and time nasogastric tube was
discontinued, length of stay, date of discharge, complications, and post-operative ileus.
Patients and nurses will be instructed on how to complete the bedside bowel record to the
nearest hour.
Inclusion Criteria:
- All patients admitted to one surgical unit (3-1) from November 1, 2007 to August 1,
2008 with a non- emergent laparoscopic colectomy.
Exclusion Criteria:
All patients with:
- History of metastatic disease
- History of inflammatory bowel disease
- Abdominal radiation treatment
- Mint allergy (the gum is mint flavored)
- Dentures
- Nasogastric tube drainage beyond the first postoperative morning
- More than one bowel anastomosis during this surgery
- Conversion to pen colectomy
- Admission to an ICI post-operatively.
We found this trial at
1
site
