Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
Condition: Postoperative Ileus.
MeSH terms: Ileus
Study type: Interventional

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
    

Intervention name(s): sugar free chewing gum; sugared chewing gum; Tab. Midazolam 7.5 mg; Inj. Midazolam 0.7mg/kg 45 min before surgery; Inj. Propofol 2.5mg/kg; Inj. Atracurium 0.5 mg/kg; Sevoflurane 2.5 vol %; Inj. Cefuroxime 1.5 g IV; Inj. Ketorolac 30 mg IV; Inj. Zantac 50mg IV
Intervention type(s): Other; Other; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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
Other intervention name(s): Orbit; Dingdong bubble gum.
Intervention MeSH terms: Cefuroxime; Cefuroxime axetil; Ketorolac; Midazolam; Propofol; Sevoflurane; Atracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cholecystectomy; laparoscopic; postoperative; ileus; chewing gum