Trial record 2 of 8 for:    Reduce-It

Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi
ClinicalTrials.gov Identifier:
NCT02162134
First received: June 6, 2014
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Postoperative Ileus.
Other: sugar free chewing gum
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Benazir Bhutto Hospital, Rawalpindi:

Primary Outcome Measures:
  • onset of hunger [ Time Frame: 4 hours after surgery until patient feels first feeling of hunger. an expected average of 12 hours. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    the patients were asked when they passed stool first time after surgery. that time was noted in terms of hours after surgery.


Secondary Outcome Measures:
  • time of surgery [ Time Frame: skin incision to skin closure time of surgery. an expected average of 1 hour ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: January 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
no chewing gum.
the no chewing gum group was control and receive no chewing gum postoperatively. While they received all other medications like anesthesia, antibiotics etc
Drug: Tab. Midazolam 7.5 mg
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery
Inj . Midazolam 0.7 mg/kg given as premedication.
Drug: Inj. Propofol 2.5mg/kg
It was given to induce anesthesia after 3 min of pre oxygenation.
Drug: Inj. Atracurium 0.5 mg/kg
It was given to induce muscle relaxation during anesthesia.
Drug: Sevoflurane 2.5 vol %
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
Drug: Inj. Cefuroxime 1.5 g IV
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
Drug: Inj. Ketorolac 30 mg IV
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period.
Drug: Inj. Zantac 50mg IV
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
Experimental: sugar free chewing gum
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.
Other: sugared chewing 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 Name: Dingdong bubble gum.
Drug: Tab. Midazolam 7.5 mg
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery
Inj . Midazolam 0.7 mg/kg given as premedication.
Drug: Inj. Propofol 2.5mg/kg
It was given to induce anesthesia after 3 min of pre oxygenation.
Drug: Inj. Atracurium 0.5 mg/kg
It was given to induce muscle relaxation during anesthesia.
Drug: Sevoflurane 2.5 vol %
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
Drug: Inj. Cefuroxime 1.5 g IV
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
Drug: Inj. Ketorolac 30 mg IV
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period.
Drug: Inj. Zantac 50mg IV
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
Experimental: sugared chewing gum
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
Other: sugar free chewing gum
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 Name: Orbit
Drug: Tab. Midazolam 7.5 mg
Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery
Inj . Midazolam 0.7 mg/kg given as premedication.
Drug: Inj. Propofol 2.5mg/kg
It was given to induce anesthesia after 3 min of pre oxygenation.
Drug: Inj. Atracurium 0.5 mg/kg
It was given to induce muscle relaxation during anesthesia.
Drug: Sevoflurane 2.5 vol %
It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
Drug: Inj. Cefuroxime 1.5 g IV
It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
Drug: Inj. Ketorolac 30 mg IV
3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period.
Drug: Inj. Zantac 50mg IV
2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery

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

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02162134

Locations
Pakistan
General Surgery Dept. Benazir Bhutto Hospital Rawalpindi
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
Benazir Bhutto Hospital, Rawalpindi
Investigators
Principal Investigator: Fazal Hussain Shah, FCPS-I Benazir Bhutto Hospital, Rawalpindi
Study Chair: Aurangzeb khan, FCPS Benazir Bhutto Hospital, Rawalpindi
Study Chair: Jahangir Sarwar Khan, FCPS,FACS Benazir Bhutto Hospital, Rawalpindi
Study Chair: Muhammad Bilal Habshi, FCPS-I Benazir Bhutto Hospital, Rawalpindi
Study Chair: Sheikh Fahad Riaz, FCPS-I Benazir Bhutto Hospital, Rawalpindi
Study Chair: Muhammad Zubair Saeed, FCPS-I Benazir Bhutto Hospital, Rawalpindi
  More Information

Publications:
Responsible Party: Dr.Fazal hussain Shah, General Surgery Resident, Benazir Bhutto Hospital, Rawalpindi
ClinicalTrials.gov Identifier: NCT02162134     History of Changes
Other Study ID Numbers: BenazirBH
Study First Received: June 6, 2014
Last Updated: June 11, 2014
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Benazir Bhutto Hospital, Rawalpindi:
cholecystectomy
laparoscopic
postoperative
ileus
chewing gum

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Atracurium
Midazolam
Ketorolac
Cefuroxime
Propofol
Sevoflurane
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Adjuvants, Anesthesia
Central Nervous System Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 22, 2014