Clinical trial NCT02162134: Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
Official title: Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus.
Keywords: cholecystectomy
laparoscopic
postoperative
ileus
chewing gum
Lead sponsor: Benazir Bhutto Hospital, Rawalpindi
Sponsor class: OTHER_GOV
First posted: 2014-06-12
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

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

Primary outcomes:
measure: onset of hunger
timeFrame: 4 hours after surgery until patient feels first feeling of hunger. an expected average of 12 hours.
measure: onset of bowel movements
timeFrame: 4 hours after surgery until the bowel sounds are present. an expected average of 10 hours.
measure: onset of flatus passing
timeFrame: 4 hours after surgery until patient passes flatus. an expected average of 18 hours.
measure: onset of defecation
timeFrame: 4 hours after surgery until patient defecated. an expected average of 24 hours.
Secondary outcomes:
measure: time of surgery
timeFrame: skin incision to skin closure time of surgery. an expected average of 1 hour
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: General Surgery Dept. Benazir Bhutto Hospital Rawalpindi
state: Punjab
Study officials:
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Fazal Hussain Shah, FCPS-I
role: PRINCIPAL_INVESTIGATOR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Aurangzeb khan, FCPS
role: STUDY_CHAIR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Muhammad Bilal Habshi, FCPS-I
role: STUDY_CHAIR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Arslan Zahid, FCPS-I
role: STUDY_CHAIR
affiliation: Benazir Bhutto Hospital, Rawalpindi
name: Muhammad Zubair Saeed, FCPS-I
role: STUDY_CHAIR
References:
citation: Gorski JP, Marks SC Jr, Cahill DR, Wise GE. Developmental changes in the extracellular matrix of the dental follicle during tooth eruption. Connect Tissue Res. 1988;18(3):175-90. doi: 10.3109/03008208809016806.
citation: Lohrmann DK, Gold RS, Jubb WH. School health education: a foundation for school health programs. J Sch Health. 1987 Dec;57(10):420-5. doi: 10.1111/j.1746-1561.1987.tb03187.x.
citation: Ageeva TS, Bukreeva EB, Khristoliubova EI. [Criteria and methods of etiological diagnosis of acute and chronic inflammatory processes in the lungs]. Ter Arkh. 1985;57(5):39-42. Russian.
citation: Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
citation: Choi H, Kim JH, Park JY, Ham BK, Shim Js, Bae JH. Gum chewing promotes bowel motility after a radical retropubic prostatectomy. Asia Pac J Clin Oncol. 2014 Mar;10(1):53-9. doi: 10.1111/ajco.12113. Epub 2013 Aug 12.
citation: Li S, Liu Y, Peng Q, Xie L, Wang J, Qin X. Chewing gum reduces postoperative ileus following abdominal surgery: a meta-analysis of 17 randomized controlled trials. J Gastroenterol Hepatol. 2013 Jul;28(7):1122-32. doi: 10.1111/jgh.12206.
citation: De Luca-Monasterios F, Chimenos-Kustner E, Lopez-Lopez J. [Effect of chewing gum on halitosis]. Med Clin (Barc). 2014 Jul 22;143(2):64-7. doi: 10.1016/j.medcli.2013.11.038. Epub 2014 Feb 20. Spanish.
citation: Sasaki-Otomaru A, Sakuma Y, Mochizuki Y, Ishida S, Kanoya Y, Sato C. Effect of regular gum chewing on levels of anxiety, mood, and fatigue in healthy young adults. Clin Pract Epidemiol Ment Health. 2011;7:133-9. doi: 10.2174/1745017901107010133. Epub 2011 Aug 5.
citation: Miles C, Johnson AJ. Chewing gum and context-dependent memory effects: a re-examination. Appetite. 2007 Mar;48(2):154-8. doi: 10.1016/j.appet.2006.07.082. Epub 2006 Oct 19.
citation: Mickenautsch S, Leal SC, Yengopal V, Bezerra AC, Cruvinel V. Sugar-free chewing gum and dental caries: a systematic review. J Appl Oral Sci. 2007 Apr;15(2):83-8. doi: 10.1590/s1678-77572007000200002.
citation: Zaghiyan K, Felder S, Ovsepyan G, Murrell Z, Sokol T, Moore B, Fleshner P. A prospective randomized controlled trial of sugared chewing gum on gastrointestinal recovery after major colorectal surgery in patients managed with early enteral feeding. Dis Colon Rectum. 2013 Mar;56(3):328-35. doi: 10.1097/DCR.0b013e31827e4971.
citation: Cavusoglu YH, Azili MN, Karaman A, Aslan MK, Karaman I, Erdogan D, Tutun O. Does gum chewing reduce postoperative ileus after intestinal resection in children? A prospective randomized controlled trial. Eur J Pediatr Surg. 2009 Jun;19(3):171-3. doi: 10.1055/s-0029-1202776. Epub 2009 Apr 9.
citation: Tamura T, Yatabe T, Kitagawa H, Yamashita K, Hanazaki K, Yokoyama M. Oral carbohydrate loading with 18% carbohydrate beverage alleviates insulin resistance. Asia Pac J Clin Nutr. 2013;22(1):48-53. doi: 10.6133/apjcn.2013.22.1.20.