General Surgery Dept. Benazir Bhutto Hospital Rawalpindi
Rawalpindi, Punjab Province, 46000, Pakistan
NCT Number: NCT02162134
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.
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Notify Me25 year–55 year
All sexes
Interventional
Not applicable
Rawalpindi, Punjab Province, 46000, Pakistan
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.
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sugar free chewing gum (orbit) was given to patients. They were asked to chew it 4 hours after surgery and continue to chew it 8 hourly for 20 to 25 min each time until oral feeding was started.
Other names: Orbit
Sugared chewing gum (singsong bubble gum) was given to patients. They were asked to chew it 4 hours after surgery and continue to chew it 8 hourly for 20 to 25 min each time until oral feeding was started.
Other names: Dingdong bubble gum.
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Inj . Midazolam 0.7 mg/kg given as premedication.
It was given to induce anesthesia after 3 min of pre oxygenation.
It was given to induce muscle relaxation during anesthesia.
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period.
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: skin incision to skin closure time of surgery. an expected average of 1 hour
Benazir Bhutto Hospital, Rawalpindi
Other Gov
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