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

NCT02162134 | Completed

• 1 other identifier: BenazirBH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus.

Keywords

cholecystectomy; laparoscopic; postoperative; ileus; chewing gum

Outcome Measures

Primary Outcomes (4)

• onset of hunger

  the patients were asked when they felt first feeling of hunger. this time was noted in terms of hours after surgery.

  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.

  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.

  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.

  4 hours after surgery until patient defecated. an expected average of 24 hours.

Secondary Outcomes (1)

• time of surgery

  skin incision to skin closure time of surgery. an expected average of 1 hour

Study Arms (3)

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

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.

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

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

Interventions

sugar free chewing gum OTHER

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.

Also known as: Orbit

sugared chewing gum

sugared chewing gum OTHER

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.

Also known as: Dingdong bubble gum.

sugar free chewing gum

Tab. Midazolam 7.5 mg DRUG

Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.

no chewing gum.; sugar free chewing gum; sugared chewing gum

Inj. Midazolam 0.7mg/kg 45 min before surgery DRUG

Inj . Midazolam 0.7 mg/kg given as premedication.

no chewing gum.; sugar free chewing gum; sugared chewing gum

Inj. Propofol 2.5mg/kg DRUG

It was given to induce anesthesia after 3 min of pre oxygenation.

no chewing gum.; sugar free chewing gum; sugared chewing gum

Inj. Atracurium 0.5 mg/kg DRUG

It was given to induce muscle relaxation during anesthesia.

no chewing gum.; sugar free chewing gum; sugared chewing gum

Sevoflurane 2.5 vol % DRUG

It was given to maintain anesthesia during surgery alongwith oxygen in air mixture

no chewing gum.; sugar free chewing gum; sugared chewing gum

Inj. Cefuroxime 1.5 g IV DRUG

It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery

no chewing gum.; sugar free chewing gum; sugared chewing gum

Inj. Ketorolac 30 mg IV DRUG

3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period.

no chewing gum.; sugar free chewing gum; sugared chewing gum

Inj. Zantac 50mg IV DRUG

2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery

no chewing gum.; sugar free chewing gum; sugared chewing gum

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Benazir Bhutto Hospital, Rawalpindi: lead

Study Sites (1)

General Surgery Dept. Benazir Bhutto Hospital Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (13)

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• 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.

  PMID: 19360548 BACKGROUND

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  PMID: 23353610 BACKGROUND

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Fazal Hussain Shah, FCPS-I

  Benazir Bhutto Hospital, Rawalpindi

  PRINCIPAL INVESTIGATOR

• Aurangzeb khan, FCPS

  Benazir Bhutto Hospital, Rawalpindi

  STUDY CHAIR

• Muhammad Bilal Habshi, FCPS-I

  Benazir Bhutto Hospital, Rawalpindi

  STUDY CHAIR

• Arslan Zahid, FCPS-I

  Benazir Bhutto Hospital, Rawalpindi

  STUDY CHAIR

• Muhammad Zubair Saeed, FCPS-I

  Benazir Bhutto Hospital, Rawalpindi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Resident

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 12, 2014
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

PA (1)