Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
- Conditions
- Postoperative Ileus.
- Interventions
- Other: sugared chewing gumOther: sugar free chewing gumDrug: Inj. Propofol 2.5mg/kgDrug: Inj. Cefuroxime 1.5 g IVDrug: Inj. Ketorolac 30 mg IVDrug: Inj. Zantac 50mg IV
- Registration Number
- NCT02162134
- Lead Sponsor
- Benazir Bhutto Hospital, Rawalpindi
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sugar free chewing gum Sevoflurane 2.5 vol % sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. sugar free chewing gum Inj. Midazolam 0.7mg/kg 45 min before surgery sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. sugared chewing gum Inj. Atracurium 0.5 mg/kg sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started sugar free chewing gum Tab. Midazolam 7.5 mg sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. no chewing gum. Inj. Cefuroxime 1.5 g IV the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc no chewing gum. Inj. Midazolam 0.7mg/kg 45 min before surgery the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc sugar free chewing gum Inj. Atracurium 0.5 mg/kg sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. sugar free chewing gum Inj. Cefuroxime 1.5 g IV sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. no chewing gum. Inj. Propofol 2.5mg/kg the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc sugar free chewing gum sugared chewing gum sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. sugared chewing gum Tab. Midazolam 7.5 mg sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started sugared chewing gum Inj. Cefuroxime 1.5 g IV sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started sugared chewing gum Inj. Ketorolac 30 mg IV sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started no chewing gum. Tab. Midazolam 7.5 mg the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc no chewing gum. Inj. Atracurium 0.5 mg/kg the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc no chewing gum. Sevoflurane 2.5 vol % the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc no chewing gum. Inj. Ketorolac 30 mg IV the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc sugared chewing gum Inj. Midazolam 0.7mg/kg 45 min before surgery sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started sugared chewing gum Inj. Propofol 2.5mg/kg sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started sugar free chewing gum Inj. Ketorolac 30 mg IV sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. sugar free chewing gum Inj. Propofol 2.5mg/kg sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. sugar free chewing gum Inj. Zantac 50mg IV sugar free chewing was given to patients 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started. sugared chewing gum sugar free chewing gum sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started sugared chewing gum Sevoflurane 2.5 vol % sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started no chewing gum. Inj. Zantac 50mg IV the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc sugared chewing gum Inj. Zantac 50mg IV sugared chewing gum will be given 4 hours after surgery then continue it 8 hourly (20 to 25 minutes each time) until oral feeding is started
- Primary Outcome Measures
Name Time Method onset of defecation 4 hours after surgery until patient defecated. an expected average of 24 hours. the patients were asked when they passed stool first time after surgery. that time was noted in terms of hours after surgery.
onset of hunger 4 hours after surgery until patient feels first feeling of hunger. an expected average of 12 hours. the patients were asked when they felt first feeling of hunger. this time was noted in terms of hours after surgery.
onset of bowel movements 4 hours after surgery until the bowel sounds are present. an expected average of 10 hours. the patients were examined by resident doctor hourly after surgery for presence of bowel sounds by a stethoscope. Additional all patient were asked when they felt first bowel sounds. the time at which the first bowel activity was present was noted in terms of hours after surgery.
onset of flatus passing 4 hours after surgery until patient passes flatus. an expected average of 18 hours. the patients were asked when they passed first flatus. this time was noted in terms of hours after surgery.
- Secondary Outcome Measures
Name Time Method time of surgery skin incision to skin closure time of surgery. an expected average of 1 hour
Trial Locations
- Locations (1)
General Surgery Dept. Benazir Bhutto Hospital Rawalpindi
🇵🇰Rawalpindi, Punjab, Pakistan