Clinical

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A clinical trial to study the effects of coffee and chewing gum on return of normal bowel function after undergoing surgery for malignant tumors of female reproductive system.


ABSTRACT: Intervention1: Chewing gum: sugarless chewing gums to chew 3 times daily at 15:00, 19:00, and, 10.00 hours until initiation of solid diet or, for 2 days whichever is earlier, starting from the day of surgery itself, each session of chewing to last 30 minutes. Intervention2: Coffee: Coffee will be dispensed from a single vending machine using same brand of coffee capsules, containing fixed and known proportion of caffeine and other ingredients : to drink three cups of caffeinated coffee daily (100 mL at 08:00, 12:00, and 16:00), beginning on Post-operative day (POD) 1. Patients have to drink the entire 100 mL amounts within 20 min under the supervision of a nursing officer. This will be contined for 2 days or upto initiatiation of solid diet, whichever is earlier. Control Intervention1: nil intervention: This group will receive post-operative care in form of hydration, antibiotics, anti-emetics, thrombo-prophylaxis, ambulation as per department protocol. They will receive analgesia by means of epidural infusion, and, paracetamol (no opioids) Primary outcome(s): The time interval in hours between skin closure of surgery to first solid oral feedTimepoint: time when the patient takes first oral feed after surgery for first time Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label

DISEASE(S): Malignant Neoplasm Of Overlappingsites Of Corpus Uteri,Malignant Neoplasm Of Uterus, Partunspecified,Malignant Neoplasm Of Fundus Uteri,Malignant Neoplasm Of Cervix Uteri, Unspecified,Malignant Neoplasm Of Endocervix,Malignant Neoplasm Of Right Ovary,Malignant Neoplasm Of Endometrium,Malignant Neoplasm Of Left Ovary,Malignant Neoplasm Of Overlappingsites Of Cervix Uteri,Malignant Neoplasm Of Overlappingsites Of Female Genital Organs,Malignant Neoplasm Of Placenta,Malignant Neoplasm Of Unspecifiedovary,Malignant Neoplasm Of Myometrium,Malignant Neoplasm Of Exocervix,Malignant Neoplasm Of Corpus Uteri, Unspecified,Malignant Neoplasm Of Isthmus Uteri

PROVIDER: 2603566 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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