EFFICACY OF PERI-OPERATIVE ADMINISTRATION OF …

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Shaik et al. World Journal of Pharmacy and Pharmaceutical Sciences

EFFICACY OF PERI-OPERATIVE ADMINISTRATION OF

PRUCALOPRIDE IN ASSESSING POST-OPERATIVE BOWEL

MOVEMENTS: A PROSPECTIVE COMPARATIVE STUDY

Shaik Bobby Parveen*1, Madamanchi Manjusha

1, P. Seetharamaiah

2, Dr. S. Uma

Shanker3, Athina Jahnavi

1 and Reddy Sucharitha

1

1Pharm D Intern, Hindu College of Pharmacy, Amaravathi Road, Guntur- 522002.

2Pharm D Director, Department of Pharmacy Practice Hindu college of Pharmacy,

Amaravathi Road, Guntur- 522002.

3General Surgeon and Laproscopic Surgeon, Lalitha Super Speciality Hospital, Guntur.

ABSTRACT

Aim: There is an extensive literature on the post operative bowel

movements after abdominal surgeries. There are, however, few studies

investigating the effect of prucalopride to treat post-operative

constipation. The aim of the study is to identify the effectiveness of

Peri-operative administration of prucalopride in assessing post-

operative bowel movements after hernia repair surgery. Materials and

Methods: The surgeon-blinded prospective randomized controlled

study included 50 hernia repair surgery patients between the ages of 18

and 80. The patients were randomized into two groups: those who had

prucalopride peri-operatively (n=25) and those who did not take

prucalopride peri-operatively (n=25). The outcome measures were post operative first bowel

movement, length of hospital stay, additional laxative need, adverse effects of the drug.

Results: Among 50 patients, 28 patients were males (56%), 22 patients were females (44%).

2mg and 1 mg dose of prucalopride were given to 25 patients and the remaining half are

taken without prucalopride. Out of 25 patients who Peri-operatively took prucalopride, 1

patient passed bowel on surgery day, 6 patients on day one after surgery and 18 patients on

the second day after surgery without any complications and got discharged early. Whereas

the 25 patients without prucalopride 2 patients passed bowel on day two after surgery, 5

patients on day three and 14 patients on day four, 4 patients on day five after surgery passed

the bowel experiencing the complications of constipation and had delayed discharge from the

WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

SJIF Impact Factor 7.632

Volume 10, Issue 7, 2100-2120 Research Article ISSN 2278 – 4357

*Corresponding Author

Dr. Shaik Bobby Parveen

Pharm D Intern, Hindu

College of Pharmacy,

Amaravathi Road, Guntur-

522002.

Article Received on

17 May 2021,

Revised on 07 June 2021,

Accepted on 27 June 2021,

DOI: 10.20959/wjpps20217-19440


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hospital. Conclusions: The study suggests that peri-operative administration of prucalopride

in hernia repair surgeries or any other abdominal surgeries effectively reduces postoperative

gastrointestinal complications and shortens the recovery of bowel movements and length of

hospital stay.

KEYWORDS: Prucalopride, Bowel movements, Hernia repair surgery, Post –Operative

constipation , Abdominal surgery.

INTRODUCTION

A hernia is an outpouching of the parietal peritoneum through a preformed or secondarily

established hiatus.[1]

Hernia formation is a multifactorial process involving endogenous

factors including age, gender, anatomic variations, and inheritance and exogenous factors

such as smoking, comorbidity, and surgical factors.[2]

Hernias may include intra- and

retroperitoneal organs, either permanently or intermittently. Depending on the size of the

outpouching, there are 1) Complete (total) hernias and 2) Incomplete (partial) hernias. Based

on their formation, there are 1) Congenital (e.g., umbilical hernias and indirect inguinal

hernias, if the processus vaginalis is open) and 2) Acquired hernias (e.g., direct, femoral, and

incisional hernias).[1]

Several different types of open and laparoscopic hernia surgery are

available. The type of surgery your doctor recommends may depend on factors such as the

size of the hernia and age, health, and medical history.[3,4]

Generally Abdominal surgeries are performed to treat diseases of stomach, bile duct, liver,

spleen, pancreas, small intestine, and large intestine. Complications, which occur after

abdominal surgery are specific to gastrointestinal system as in preoperative period.[5,6]

The

major GI complications seen after abdominal surgeries are paralytic ileus, bowel injury,

alterations in gastrointestinal motility, gastric dilation, bowel Obstruction, postoperative

Fecal Impaction.[7]

Problems regarding bowel elimination are quite common in patients who

underwent abdominal surgery. It was reported that this ratio was 25% to 40% in hospitalized

patients who underwent surgery.[8,9]

Constipation is an important symptom affecting

postoperative healing, quality of life, comfort, respiratory and circulatory systems of the

patients, and quality of nursing care in the postoperative period.[5,8,10-12]

Place of surgical

intervention, type of anesthesia, trauma of intestines during the operation, duration of

postoperative immobility, suppression of defecation feeling, use of bedpan, inability to

protect privacy, inability of the patients to verbally express their discomfort, using

opioids/non opioid analgesics, fluid intake and alterations in dietary habits are effective in


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bowel elimination in the early postoperative period.[10-14]

Several factors may contribute to

constipation after surgery. These include: Narcotic pain relievers such as opioids, General

anesthesia and spinal anesthesia, an inflammatory stimulus such as trauma or infection,

an electrolyte, fluid, or glucose imbalance, Prolonged inactivity, Changes to diet, especially

insufficient fiber.[15]

Gastrointestinal prokinetics promote or increase the co-ordination of the gut wall contractions

leading to enhancement of propulsive motility and, consequently, caudal displacement of

luminal contents.[16]

5-Hydroxytryptamine(4) (5-HT(4)) receptors are an interesting target for

the management of patients in need of gastrointestinal (GI) promotility treatment. They have

proven therapeutic potential to treat patients with GI motility disorders. Recent efforts have

led to the discovery of a series of selective 5-HT(4) receptor ligands, with prucalopride being

the most advanced in clinical development. The selectivity of these new compounds clearly

differentiates them from the older generation compounds by minimizing the potential of

target-unrelated side effects. Selective 5-HT(4) receptor agonists might thus prove to be

innovative drugs with an attractive safety profile for better treatment of patients suffering

from hypomotility disorders.[17]

The study was conducted in the tertiary center with the highest number of hernia repair

patients. The goal of this randomized controlled trial is to investigate whether preoperative

administration of prucalopride promotes the return of gastrointestinal activity in patients

undergoing abdominal surgeries.

MATERIALS AND METHODS

Arandomized controlled comparative study was conducted at lalitha superspeciality hospital.

The patients are randomized into 2 groups : with prucalopride and without prucalopride. All

enrolled subjects were informed about their participation in the study, written informed

consent was obtained and randomization was performed as soon as the patients were admitted

to our unit. A suitable data collection form along with a questionnaire form was designed for

the use in this study. Relavant data such as demographic details, disease history, diagnosis,

route, frequency, duration of therapy, adverse events will be collected and documented from

medical records and by the patient interview.

STUDY CRITERIA

Inclusion criteria

https://www.healthline.com/health/opioid-induced-constipation

https://www.healthline.com/health/food-nutrition/how-to-prevent-an-electrolyte-imbalance

https://www.healthline.com/health/food-nutrition/how-much-fiber-per-day


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1) Patients of age group above 18 years and below 80 years are included in this study.

2) Patients who underwent abdominal surgery, majorly hernia (all types of hernia).

3) Patients with peritoneal carcinomatosis are also included.

4) Patients who are not having any laxatives in previous history (2 months).

5) Patients who are hospitalized for abdominal surgery.

Exclusion criteria

1) Patients of age group below 18 years and above 80 years of age.

2) Patient who had taken laxatives or any other drugs which increases GI motility from 2

months are excluded.

3) Patients who have suicidal ideation or depressed patients.

4) Patient with known cases of inflammatory conditions such as chron’s disease, ulcerative

colitis and toxic megacolon/megarectum.

5) Pregnant and lactating women.

6) Patients with Intestinal perforation or obstruction due to structural or functional disorder of

the gut wall, obstructive ileus.

7) Patients who are not willing to participate in this study.

8) Patients who are on calcium channel blockers and muscle relaxants

SOURCES OF DATA

All the relevant and necessary data will be collected from

1) Physical examination

2) Treatment charts

3) Interviewing the patient & patient care takers

4) Interviewing nurse, physician.

5) Any other relavent sources

The primary outcome measure of the study was first bowel movement (hours from end of

operation). Secondary outcome measures were the length of hospital stay, Patients were

evaluated three times a day by an outcome assessor who was blinded to the study allocation.

Patients bowel sounds were checked six times 2 a day postoperatively using a standard

stethoscope until the first bowel sounds were noticed. Patients were also instructed to notify

ward nurses or investigators immediately after the first passage of flatus, bowel movements,

defecation, and passing gas.


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All the raw data was collected, entered in EXCEL SHEET 2007 in windows 10 version, the

statistical analysis was done in SPSS 16.0 software by an appropriate statistical methods

independent T test for knowing the significant p-value <0.005 (confidence interval 95%).

RESULTS

The randomized controlled trial study was conducted with 50 patients. None of the patients

left the sample during the study. Flowchart of the study is demonstrated in

Tables 5.1 Age distribution of patients from the study.

Based on age, patients are grouped as following.

AGE NUMBER OF PATIENTS PERCENTAGE

18-30 YEARS 4 8%

31-42 YEARS 13 26%

43-54 YEARS 19 38%

55-66 YEARS 11 22%

67-80 YEARS 3 6%

Age of patients observed as follows, 8% of patients were between 18-30 years of age,

followed by 26% of patients were between 31-42 years years of age, 38% were between

43-54 years of age, 22% patients were between 55-66 years and 6% of patients were

between 67-80 years of age group.

Figure 5.1: Age distribution of patients from the study.


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Table 5.2 Gender Differentiation.

GENDER NO.OF PATIENTS PERCENTAGE

Male 28 56%

Female 22 44%

Table 5.2 shows the patient charecterstics based on gender.

Out of 50 patients 28 patients were males (56%), 22 pateints were females (44%). It may

infer that men might me more at risk of developing hernia compared to females.

Figure 5.2 Gender Differntiation of patients in the study.

Table 5.3 Comorbidities.

COMORBIDITIS NUMBER OF PATIENTS PERCENTAGE

Hypertension 13 26%

Diabetes mellitus 7 14%

Hypothyroidism 3 6%

Cardiac problems 6 12%

Table 5.3 shows the patient charecterstics with co-morbiditis.

26% of patients were reported with hypertension, 14% of patients were reported with

diabetes millites, 6% of patients with hypothyroidism and 12% of patients were reported

with cardiac problems.


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Figure 5.3 Comorbiditis of patients in the study.

Table 5.4 Body Mass Index (BMI)

BODY MASS INDEX NO.OF PATIENTS PERCENTAGE

Normal 25 50 %

Over weight 14 28%

Obese 11 22%

Table 5.4 shows the patients BMI (BODY MASS INDEX).

In this 50% of patients (25 patients) were normal in weight, 28% of patients (14 patients)

were over weight and 22% of patients (11 patients) were obese in our study.

Figure 5.4 Body Mass Index (BMI).


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Table 5.5 Diagnosis.

DIAGNOSIS NO.OF PATIENTS PERCENTAGE

Umbilical Hernia 10 20%

Inguinal Hernia 22 44%

Incisional Hernia 14 28%

Epigastric Hernia 3 6%

Hiatus Hernia 1 2%

Out of 50 patients in the study, 20 % of patients are diagnosed with umbilical hernia, 44% of

patients were diagnosed with inguinal hernia, 28% of patients were diagnosed with incisional

hernia and 6% of patients were diagnosed with hiatus hernia.

Figure 5.5 Diagnosis.

Table 5.6 Prucalopride Dose Distribution

Prucalopride dose was distributed based upon the age of the patient. 2 mg was given in 18-60

years of age and 1 mg was given in 61-80 years of age.

PRUCALOPRIDE DOSE NO.OF PATIENTS PERCENTAGE

1 mg 6 24 %

2 mg 19 76 %

Out of 25 patients, 76% of patients (19 patients) were take 2 mg of prucalopride and 24% of

patients (6 patients) were take 1 mg of prucalopride.


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Figure 5.6 Prucalopride Dose Distribution.

Table 5.7 Surgery Procedure.

SURGERY PROCEDURE NO.OF PATIENTS PERCENTAGE

Open 12 24 %

Laproscopic 38 76 %

Out of 50 patients, open surgery was done in 24% of patients (12 patients) and laproscopic

surgery was done in 76% of patients (38 patients).

Figure 5.7 Surgery Procedure.


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Table 5.8 Type of Anesthesia Given in the Patient.

TYPE OF ANAESTHESIA NO.OF PATIENTS PERCENTAGE

General 14 28 %

spinal 36 72 %

Out of 50 patients, general anesthesia was given in 28% of patients (14 patients) and spinal

anesthesia was given in 72% of patients (36 patients).

Figure 5.8 Type of Anesthesia Given in the Patient.

Table 5.9 Type of Analgesic Given in the Patient.

TYPE OF ANALGESIC NO.OF PATIENTS PERCENTAGE

Opioid 32 64 %

Non opioid 18 36 %

Out of 50 patients, 64% of patients (32 patients) were take opioid analgesic and 36% of

patients (18 patients) were take non opioid analgesic.


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Figure 5.9 Type of Analgesic Given in the Patient.

Table 5.10 Adverse Effects Were Occurred in the Patients Taking Prucalopride.

ADVERSE EFFECTS NO.OF PATIENTS PERCENTAGE

Diarrhoea 2 8%

Head ache 1 4%

Out of 25 patients, 2 patients were experienced diarrhoea and 1 patient was experienced head

ache.

Figure 5.10 Adverse Effects were Occurred in the Patients Taking Prucalopride.


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Table 5.11 Post Operative Mobilisation of The Patient.

POST OPERATIVE

MOBILISATION NO.OF PATIENTS PERCENTAGE

Active 31 62%

Sedentary 19 38%

Out of 50 patients, 62% of the patients (31 patients) were active and 38% of the patients (19

patiens) were sedentary.

Figure 5.11 Post Operative Mobilisation of The Patient.

Table 5.12 Bowel Movements of The Patient.

BOWEL

MOVEMENTS OF

THE PATIENT

NUMBER OF PATIENTS

BEFORE

SURGERY SURGERY

DAY

AFTER SURGERY

DAY 1 DAY 2 DAY 1 DAY 2 DAY 3 DAY 4 DAY 5

WITH

PRUCALOPRIDE 23 25 1 6 18 0 0 0

WITH OUT

PRUCALOPRIDE 20 18 0 0 2 5 14 4


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Figure 5.12 Bowel Movements of The Patient.

Table 5.13 Patient Discharge After Surgery.

PATIENT

DISCHARGE

NUMBER OF PATIENTS DISCHARGED AFTER

SURGERY

DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 DAY 6

WITH

PRUCALOPRIDE 0 2 6 17 0 0

WITH OUT

PRUCALOPRIDE 0 0 2 5 14 4


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Figure 5.13 Patient Discharge After Surgery.

Table 5.14 Patient Recovery with Prucalopride.

PATIENT RECOVERY

WITH PRUCALOPRIDE NO.OF PATIENTS

Early 23

Delayed 2

Out of 25 patients, recovery of 23 patients were early and recovery of 2 patients were

delayed.


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Figure 5.14 Patient Recovery with Prucalopride.

Table 5.15 Patient Recovery with Out Prucalopride.

PATIENT RECOVERY WITH

OUT PRUCALOPRIDE NO.OF PATIENTS

Early 3

Delayed 22

Out of 25 patients, recovery of 3 patients were early and recovery of 22 patients were

delayed.

Figure 5.15 Patient Recovery with Out Prucalopride.


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STATISTICAL ANALYSIS

DAY 1 RESULTS

A total of 50 patients are included in the study; among them 25 patients are treated with

prucalopride and 25 patients without prucalopride. The mean of bowel movement of these

two groups on the DAY-1 after surgery was calculated statistically. The mean of bowel

movement WITH PRUCALOPRIDE on DAY-1 is 0.28 + 0.45 and the mean of bowel

movement WITHOUT PRUCALOPRIDE on DAY-1 is 0.0+0.0. This shows there is a

significant difference WITH and WITHOUT prucalopride.

Group Statistics

Prucaloprie N Mean Std.

Deviation

Std. Error

Mean

bowelmovement with prucalopride 25 .2800 .45826 .09165

without prucalopride 25 .0400 .20000 .00000

Table Statistical analysis of bowel movement WITH and WITHOUT PRUCALOPRIDE on

DAY-1 after surgery.

Independent Samples Test (continued..)

t-test for Equality of Means

Sig. (2-tailed) Mean

Difference Std. Error

Difference

Bowelmovement

Equal variances assumed .004 .28000 .09165

Equal variances not

assumed .005 .28000 .09165



95% Confidence Interval of the

Difference

Lower Upper

Bowelmovement Equal variances assumed .09572 .46428

Equal variances not assumed .09084 .46916

Independent Samples Test

Levene's Test for Equality

of Variances

t-test for Equality

of Means

F Sig. t df

bowelmovement Equal variances assumed 99.967 .000 3.055 48

Equal variances not assumed 3.055 24.000


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STATISTICAL ANALYSIS

DAY 2 RESULTS

A total of 50 patients are included in the study; among them 25 patients are treated with

prucalopride and 25 patients without prucalopride. The mean of bowel movement of these

two groups on the DAY-2 after surgery was calculated statistically. The mean of bowel

movement WITH PRUCALOPRIDE on DAY-2 is 0.72+0.45 and the mean of bowel

movement WITHOUT PRUCALOPRIDE on DAY-2 is 0.08+0.27. This shows there is a

significant difference WITH and WITHOUT prucalopride.

Group Statistics

prucalopride N Mean Std.

Deviation

Std. Error

Mean

bowelmovement with prucalopride 25 .7200 .45826 .09165

without prucalopride 25 .0800 .27689 .05538

Independent Samples Test

Levene's Test for Equality

of Variances

t-test for Equality of

Means

F Sig. t df

bowelmovement

Equal variances assumed 17.291 .000 5.977 48

Equal variances not

assumed 5.977 39.463



Sig. (2-tailed) Mean

Difference

Std. Error

Difference

bowelmovement

Equal variances assumed .000 .64000 .10708

Equal variances not

assumed .000 .64000 .10708



95% Confidence Interval of the

Difference

Lower Upper

Bowelmovement Equal variances assumed .42470 .85530

Equal variances not assumed .42349 .85651

When the coefficient of variation was calculated betweenthe WITH PRUCALOPRIDE

and WITHOUT PRUCALOPRIDE, the CV of WITHPRUCALOPRIDE is less than

CV of WITHOUT PRUCALOPRIDE.

So, WITH PRUCALOPRIDE is efficient than WITHOUT PRUCALOPRIDE


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DISCUSSION

This study is to determine the effectiveness of prucalopride in assessing post operative bowel

movements after abdominal surgeries majorly hernia surgeries. The prevalence of hernia

disease was greater in male subjects than in female subjects that are 56% in Males and 44%

in Females. The prevalence of hernia disease was greater in male subjects than in female

subjects that are 56% in Males and 44% in Females. In the taken sample 26% patients are

hyper tensive, 14% of the patients are diabetic, 12% of the patients have cardiac problems

and 6% have hypothyroidism. Based on the diagnosis most of the subjects i.e; 44% were

diagnosed with inguinal hernia, 28% with incisional hernia, 20% of patients with umbilical

hernia, 6% of patient’s with epigastric hernia and 2% of patients with hiatus hernia. In our

study of 50 subjects, 25 subjects were prescribed with prucalopride. We used two doses of

Prucalopride. They are 2mg, 1mg. where as 2 Mg was prescribed to patients of age group

between 18-60 years where as 1 mg of prucalopride was prescribed to patients of age group

between 60 -80 years. Out of these 25 subjects 2mg was prescribed in more patients i.e, 76%

(19 patients) where as 1 mg was prescribed to 24% (6 patients). We observed that both doses

2mg and 1 mg of prucalopride are efficient and showed significant improvement in the bowel

movement in almost all the patients prescribed. In our study we mainly concentrated on the

improvement of bowel movements in patients after hernia surgeries by monitoring the bowel

movements of patients day wise. According to our study results 18 patients out of 25 patients

prescribed with prucalopride passed bowel after the second day of the surgery, where as 6

patients out of 25 patients passed bowel after the day of the surgery and 1 patient out of 25

patient passed bowel on the surgery day itself without experiencing any difficulties or

complications. In this study the patients without prucalopride the patients suffered from post

operative constipation where as the 4 subjects out of 25 passed bowel on the fifth day after

surgery, the highest number of 14 subjects out of 25 passed bowel on the fouth day after

surgery, 5 subjects out of 25 on day 3 and 2 subjects out of 25 on day 2. The patients who

passed the bowel mainly on the day 4 and day 5 after surgery experienced problems of

constipation like hard stools, straining, pain while passing bowel secondary to straining,

excessive time needed to pass the bowel and sensation of incomplete bowel evacuation after

passing bowel. According to the prospective randomized trail conducted by Eur J Surg, on

how the enemas given before abdominal surgeries are useful to patients they came to a

conclusion that preoperative enemas delay rather than improve the return of normal

peristalsis after surgery. Instead the study has also recommend this practice should be


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abandoned. Now a days as the usage of enemas before abdominal surgeries are adandoned by

the surgeons, the newly approved selective serotonin agonist drug prucalopride has been

choosen for this study to know its efficacy and safety on post operative bowel movement

when given peri operatively to the selected subjects. In this study the effect of factors such as

general anesthesia, surgery procedure and analgesic usage is also considered as these factors

also majorly causes post operative constipation. General anesthesia is found to be one of the

factor for post operative constipation, and here in our study out of 50 subjects, spinal

anesthesia was given to the 28% of the subjects general anesthesia was given to 72% of

subjects. Out of these 72% of the subjects of general anesthesia, 36% are with prucalopride

who passed the bowel within the second day and remaining 36% of subjects took upto 5 days

after surgery to eliminate the bowel. In our study of total 50 subjects, the opiod analgesic

tramadol was prescribed to to a total of 32 subjects i,e 64% of the subjects where as to the 18

subjects the non opiod analgesic diclofenac was prescribed. Out of these 64% of subjects

with opiod analgesic the subjects to whom prucalopride is prescribed is 36 % and all these

36% subjects passed bowel within the second day after surgery without any complication

where as the remaining 28% of the subjects without prucalopride eliminated bowel mostly on

the day 4 after surgery experiencing difficulty in bowel elimination. In this study the effect of

factors such as general anesthesia, surgery procedure and analgesic usage is also considered

as these factors also majorly causes post operative constipation. General anesthesia is found

to be one of the factor for post operative constipation, and here in our study out of 50

subjects, spinal anesthesia was given to the 28% of the subjects general anesthesia was given

to 72% of subjects. Out of these 72% of the subjects of general anesthesia, 36% are with

prucalopride who passed the bowel within the second day and remaining 36% of subjects

took upto 5 days after surgery to eliminate the bowel. In our study of total 50 subjects, the

opiod analgesic tramadol was prescribed to to a total of 32 subjects i,e 64% of the subjects

where as to the 18 subjects the non opiod analgesic diclofenac was prescribed. Out of these

64% of subjects with opiod analgesic the subjects to whom prucalopride is prescribed is 36%

and all these 36% subjects passed bowel within the second day after surgery without any

complication where as the remaining 28% of the subjects without prucalopride eliminated

bowel mostly on the day 4 after surgery experiencing difficulty in bowel elimination. In our

study, 50 out of 48 subjects with prucalopride got dischared on the third day after surgery

where as out of the 50 subjects without prucalopride most of the subjects got discharged on

the sixth day after surgery. That means with the help of our study we had reduced the extra 3

day hospital stay and their medical expenses to the subjects with prucalopride.


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CONCLUSION

In this study with the help of the drug prucalopride we minimized many complications

occuring due to post operative constipation after surgery. we not only increased patients

quality of life but also economically decreased patients burden by decreasing the hospital stay

of the patients. As the patients with prucalopride recovered and got discharged early

compared to the patients without prucalopride.

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