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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02162134 |
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Date of registration:
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06/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy
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Scientific title:
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Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02162134 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Fazal Hussain Shah, FCPS-I |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Muhammad Zubair Saeed, FCPS-I |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Arslan Zahid, FCPS-I |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Aurangzeb khan, FCPS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Name:
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Muhammad Bilal Habshi, FCPS-I |
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Address:
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Telephone:
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Email:
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Affiliation:
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Benazir Bhutto Hospital, Rawalpindi |
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Key inclusion & exclusion criteria
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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
Age minimum:
25 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Ileus.
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Intervention(s)
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Drug: Inj. Zantac 50mg IV
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Other: sugared chewing gum
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Drug: Inj. Cefuroxime 1.5 g IV
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Drug: Inj. Propofol 2.5mg/kg
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Drug: Sevoflurane 2.5 vol %
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Other: sugar free chewing gum
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Drug: Tab. Midazolam 7.5 mg
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Drug: Inj. Atracurium 0.5 mg/kg
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Drug: Inj. Midazolam 0.7mg/kg 45 min before surgery
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Drug: Inj. Ketorolac 30 mg IV
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Primary Outcome(s)
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onset of hunger
[Time Frame: 4 hours after surgery until patient feels first feeling of hunger. an expected average of 12 hours.]
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onset of defecation
[Time Frame: 4 hours after surgery until patient defecated. an expected average of 24 hours.]
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onset of flatus passing
[Time Frame: 4 hours after surgery until patient passes flatus. an expected average of 18 hours.]
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onset of bowel movements
[Time Frame: 4 hours after surgery until the bowel sounds are present. an expected average of 10 hours.]
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Secondary Outcome(s)
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time of surgery
[Time Frame: skin incision to skin closure time of surgery. an expected average of 1 hour]
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Secondary ID(s)
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BenazirBH
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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