Postoperative Ileus.NCT02162134
Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
A study testing sugar free chewing gum, sugared chewing gum and Tab. Midazolam 7.5 mg in people with Postoperative Ileus., run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Ileus.
- What is being tested?
- sugar free chewing gum, sugared chewing gum and Tab. Midazolam 7.5 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
- Patients with age range of 25 to 55 years
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
General Surgery Dept. Benazir Bhutto Hospital Rawalpindi
Rawalpindi, Punjab Province, 46000
About this study
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.
Read the 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
- Conditions
- Postoperative Ileus.
- Being tested
- 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
- Keywords
- cholecystectomy, laparoscopic, postoperative, ileus, chewing gum
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugar free chewing gumOther
Also called Orbit
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 gumOther
Also called Dingdong bubble gum.
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 mgDrug
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Inj. Midazolam 0.7mg/kg 45 min before surgeryDrug
Inj . Midazolam 0.7 mg/kg given as premedication.
Inj. Propofol 2.5mg/kgDrug
It was given to induce anesthesia after 3 min of pre oxygenation.
Inj. Atracurium 0.5 mg/kgDrug
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 IVDrug
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
Inj. Ketorolac 30 mg IVDrug
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period.
Inj. Zantac 50mg IVDrug
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| no chewing gum. | Other | the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc Receives: Drug: Tab. Midazolam 7.5 mg; Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery; Drug: Inj. Propofol 2.5mg/kg; Drug: Inj. Atracurium 0.5 mg/kg; Drug: Sevoflurane 2.5 vol %; Drug: Inj. Cefuroxime 1.5 g IV; Drug: Inj. Ketorolac 30 mg IV; Drug: Inj. Zantac 50mg IV |
| sugar free chewing gum | Experimental | 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. Receives: Other: sugared chewing gum; Drug: Tab. Midazolam 7.5 mg; Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery; Drug: Inj. Propofol 2.5mg/kg; Drug: Inj. Atracurium 0.5 mg/kg; Drug: Sevoflurane 2.5 vol %; Drug: Inj. Cefuroxime 1.5 g IV; Drug: Inj. Ketorolac 30 mg IV; Drug: Inj. Zantac 50mg IV |
| sugared chewing gum | Experimental | 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 Receives: Other: sugar free chewing gum; Drug: Tab. Midazolam 7.5 mg; Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery; Drug: Inj. Propofol 2.5mg/kg; Drug: Inj. Atracurium 0.5 mg/kg; Drug: Sevoflurane 2.5 vol %; Drug: Inj. Cefuroxime 1.5 g IV; Drug: Inj. Ketorolac 30 mg IV; Drug: Inj. Zantac 50mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset of hunger
the patients were asked when they felt first feeling of hunger. this time was noted in terms of hours after surgery.
Measured: 4 hours after surgery until patient feels first feeling of hunger. an expected average of 12 hours.
onset of bowel movements
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.
Measured: 4 hours after surgery until the bowel sounds are present. an expected average of 10 hours.
onset of flatus passing
the patients were asked when they passed first flatus. this time was noted in terms of hours after surgery.
Measured: 4 hours after surgery until patient passes flatus. an expected average of 18 hours.
onset of defecation
the patients were asked when they passed stool first time after surgery. that time was noted in terms of hours after surgery.
Measured: 4 hours after surgery until patient defecated. an expected average of 24 hours.
Secondary outcomes (1)
time of surgery
Measured: skin incision to skin closure time of surgery. an expected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postoperative Ileus.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benazir Bhutto Hospital, Rawalpindi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi
- Investigators
- Fazal Hussain Shah, FCPS-I, Principal investigator, Benazir Bhutto Hospital, RawalpindiAurangzeb khan, FCPS, Study chair, Benazir Bhutto Hospital, RawalpindiMuhammad Bilal Habshi, FCPS-I, Study chair, Benazir Bhutto Hospital, RawalpindiArslan Zahid, FCPS-I, Study chair, Benazir Bhutto Hospital, RawalpindiMuhammad Zubair Saeed, FCPS-I, Study chair, Benazir Bhutto Hospital, Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162134
- Sponsor's protocol ID
- BenazirBH
- Status last verified
- Jan 2015
- First submitted
- 6 Jun 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3219849Lohrmann 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.
PubMed 3326971Ageeva 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.
PubMed 3895549Holte 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.
PubMed 11091234Choi 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.
PubMed 23937408Li 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.
PubMed 23551339De 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.
PubMed 24559542Sasaki-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.
PubMed 21866229Miles 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.
PubMed 17055609Mickenautsch 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.
PubMed 19089107Zaghiyan 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.
PubMed 23392147Cavusoglu 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.
PubMed 19360548Tamura 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.
PubMed 23353610
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02162134
- Acronym / sponsor ID
- BenazirBH
- Conditions
- Postoperative Ileus.
- Keywords
- cholecystectomy, laparoscopic, postoperative, ileus, chewing gum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Benazir Bhutto Hospital, RawalpindiOther government
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no chewing gum. | Other | Drug: Tab. Midazolam 7.5 mg, Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery, Drug: Inj. Propofol 2.5mg/kg, Drug: Inj. Atracurium 0.5 mg/kg, Drug: Sevoflurane 2.5 vol %, Drug: Inj. Cefuroxime 1.5 g IV, Drug: Inj. Ketorolac 30 mg IV, Drug: Inj. Zantac 50mg IVthe 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 | Experimental | Other: sugared chewing gum, Drug: Tab. Midazolam 7.5 mg, Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery, Drug: Inj. Propofol 2.5mg/kg, Drug: Inj. Atracurium 0.5 mg/kg, Drug: Sevoflurane 2.5 vol %, Drug: Inj. Cefuroxime 1.5 g IV, Drug: Inj. Ketorolac 30 mg IV, Drug: Inj. Zantac 50mg IVsugar 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 | Experimental | Other: sugar free chewing gum, Drug: Tab. Midazolam 7.5 mg, Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery, Drug: Inj. Propofol 2.5mg/kg, Drug: Inj. Atracurium 0.5 mg/kg, Drug: Sevoflurane 2.5 vol %, Drug: Inj. Cefuroxime 1.5 g IV, Drug: Inj. Ketorolac 30 mg IV, Drug: Inj. Zantac 50mg IVsugared 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 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing elective laparoscopic cholecystectomy for gallstone disease.
- Patients with age range of 25 to 55 years
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sugar free chewing gumAlso: OrbitSugar 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 | sugared chewing gum |
| sugared chewing gumAlso: Dingdong bubble gum.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 | sugar free chewing gum |
| Tab. Midazolam 7.5 mgTab. Midazolam 7.5 mg will be given to all patients at night before surgery. | Drug | no chewing gum., sugar free chewing gum, sugared chewing gum |
| Inj. Midazolam 0.7mg/kg 45 min before surgeryInj . Midazolam 0.7 mg/kg given as premedication. | Drug | no chewing gum., sugar free chewing gum, sugared chewing gum |
| Inj. Propofol 2.5mg/kgIt was given to induce anesthesia after 3 min of pre oxygenation. | Drug | no chewing gum., sugar free chewing gum, sugared chewing gum |
| Inj. Atracurium 0.5 mg/kgIt was given to induce muscle relaxation during anesthesia. | Drug | no chewing gum., sugar free chewing gum, sugared chewing gum |
| Sevoflurane 2.5 vol %It was given to maintain anesthesia during surgery alongwith oxygen in air mixture | Drug | no chewing gum., sugar free chewing gum, sugared chewing gum |
| Inj. Cefuroxime 1.5 g IVIt was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery | Drug | no chewing gum., sugar free chewing gum, sugared chewing gum |
| Inj. Ketorolac 30 mg IV3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period. | Drug | no chewing gum., sugar free chewing gum, sugared chewing gum |
| Inj. Zantac 50mg IV2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery | Drug | no chewing gum., sugar free chewing gum, sugared chewing gum |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
time of surgery
Time frame: skin incision to skin closure time of surgery. an expected average of 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- Background: PubMed 3219849Gorski 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.
- Background: PubMed 3326971Lohrmann 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.
- Background: PubMed 3895549Ageeva 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.
- Background: PubMed 11091234Holte 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.
- Background: PubMed 23937408Choi 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.
- Background: PubMed 23551339Li 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.
- Background: PubMed 24559542De 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.
- Background: PubMed 21866229Sasaki-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazal Hussain Shah, FCPS-I principal investigator
Benazir Bhutto Hospital, Rawalpindi
Aurangzeb khan, FCPS study chair
Benazir Bhutto Hospital, Rawalpindi
Muhammad Bilal Habshi, FCPS-I study chair
Benazir Bhutto Hospital, Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugar free chewing gum, sugared chewing gum and Tab. Midazolam 7.5 mg in people with Postoperative Ileus., run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset of hunger (time frame: 4 hours after surgery until patient feels first feeling of hunger. an expected average of 12 hours.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02162134, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.