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Completed

NCT Number: NCT02162134

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Surgery Dept. Benazir Bhutto Hospital Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
  • Patients with age range of 25 to 55 years

Exclusion criteria

  • H/O chronic illness like DM, IHD, CRF, CLD
  • Immunocompromised patients.
  • Previous history of any chemotherapy or radiotherapy, any history of repeated infections, pneumonia.
  • Patients with H/O concurrent intestinal illnesses like Tuberculosis, ulcerative colitis, Crohn's disease, acute or chronic diarrhea, constipation etc.
  • Previous hepatobilliary surgery.
  • H/O use of antispasmodics, or drugs affecting the intestinal motility within last 72 hours before and after surgery (tricyclic antidepressants, antipsychotics)
  • Patients who develop the postop complications like wound infection, intra-abdominal collections etc.
  • Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to open cholecystectomy.
  • Cholecystectomy in which the biliary leakage was complication, either in the drain or later on detected via ultrasound

Treatment and study plan

sugar free chewing gum

Other

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

Other

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

Drug

Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.

Inj. Midazolam 0.7mg/kg 45 min before surgery

Drug

Inj . Midazolam 0.7 mg/kg given as premedication.

Inj. Propofol 2.5mg/kg

Drug

It was given to induce anesthesia after 3 min of pre oxygenation.

Inj. Atracurium 0.5 mg/kg

Drug

It was given to induce muscle relaxation during anesthesia.

Sevoflurane 2.5 vol %

Drug

It was given to maintain anesthesia during surgery alongwith oxygen in air mixture

Inj. Cefuroxime 1.5 g IV

Drug

It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery

Inj. Ketorolac 30 mg IV

Drug

3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period.

Inj. Zantac 50mg IV

Drug

2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery

Primary outcomes

  1. onset of hunger

    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.

  2. onset of bowel movements

    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.

  3. onset of flatus passing

    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.

  4. onset of defecation

    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.

Secondary outcomes

  1. time of surgery

    Time frame: skin incision to skin closure time of surgery. an expected average of 1 hour

Sponsors and collaborators

Lead sponsor

Benazir Bhutto Hospital, Rawalpindi

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2014
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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