Postoperative Ileus. Clinical Trial
Official title:
Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy is now very common procedure to remove the gall bladder from abdomen. After this procedure many patients suffer from the non functioning of intestine and stomach which is very common after any abdominal surgery. Many efforts tried to reduce this non functioning period or postoperative ileus but non of them was superior later on. The investigators want to evaluate the role of chewing gum for reducing postoperative ileus. The investigators hypothesis is that Chewing gum after laparoscopic cholecystectomy reduces postoperative ileus and sugared preparations are more effective to reduce it.
Laparoscopic cholecystectomy is considered now the gold standard for gall stone disease.
Postoperative ileus after any abdominal surgery is common complication, it is considered as
physiological response and is the main cause of postoperative abdominal pain, discomfort and
increased duration of hospital stay. Postoperative ileus (POI) may last up to 5 days after
uncomplicated abdominal surgery. Activity of small intestine returns within 24 hours while
stomach and large intestine take up to 36 and 72 hours to regain motility.3 The use of early
feeding, medications like cisapride etc. have been used to reduced POI but none of them has
been significantly useful on further research work.
Gum chewing after abdominal surgery reduces the duration of POI, pain and discomfort. Gum
chewing also reduces halitosis, dental caries, elevates mood and reduces stress which are
additional benefits. Many studies proved that the chewing gum has only placebo effect after
surgery in adults and children. Sugar-free chewing gum has been focused mainly in studies.
Perioperative role of glucose intake has shown many benefits like reducing insulin
resistance.
In this study the investigators wanted to evaluate the role of chewing gum in reducing POI
in laparoscopic cholecystectomy and further exploration to see the whether which chewing gum
is more beneficial, sugar-free or sugared. If the study proves the beneficial effect of
chewing gum then the investigators can have better management of patients postoperatively by
sugared chewing gum which is readily available and inexpensive.
After meeting inclusion and exclusion criteria, All patients were given Tab. Midazolam 7.5
mg PO at night before surgery and received same standard general anesthesia with
endotracheal intubation. Inj. Midazolam IV 0.7 mg/kg was given 45 min before surgery as
premedication. Anesthesia was induced by propofol (2.5 mg/kg) after 3 minutes of
preoxygenation. Muscle relaxation was achieved by atracuium (0.5 mg/kg). Anesthesia was
maintained with sevoflurane (2.5 vol %) and oxygen in air mixture (0.50 ratio). Ventilation
was controlled mechanically and end tidal normocapnia was maintained by keeping pCO2 at
35-38 mmHg.
Following medications were given to patients during the process.
- Inj. Cefuroxime 1.5 gm. IV (2 doses, 1st dose 30-60 min before surgery and 2nd dose 6
hours after surgery)
- Inj. Ketorolac 30mg IV (3 doses total, 1st dose immediate postop, 2nd and 3rd at 8 and
16 hours after surgery respectively)
- Inj. Zantac 50 mg IV (2 doses total, 1st immediate postop and 2nd at 12 hours after
surgery) All patients were operated by the consultant surgeons. Duration of surgery was
noted. Patients were divided randomly into 3 groups equally; at the end each contained
30 patients each. Group A was the control group, group B received sugar-free chewing
gum (Orbit) and group C received sugared chewing gum (Dingdong chewing gum from
hilalcandy). Both B and C groups were asked to start chew gum 4 hours after surgery
then continue it 8 hourly (20-25 minutes each time) until oral feeding was started.
Onset of hunger, bowel movements, flatus passing and defecation were noted. Bowel
movements were examined via stethoscope hourly after surgery. All patients received
same standard postoperative care.
All the data was recorded on specially designed Performa. Statistical analysis: Data was
analyzed using SPSS version 12. Mean and standard deviation were calculated for quantitative
data like age, duration of surgery, time of onset of hunger, bowel movements, flatus passing
and defecation. Frequency and percentages were calculated for qualitative data like gender.
The results were finally analyzed and compared for the three groups using one way ANOVA. The
data of any two groups (A versus B, A versus C, B versus C) was analyzed by independent
sample t test. Pearson correlation was used to see the correlation between duration of
surgery and bowel movements. A p value <0.05 was considered significant
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment