The Effects of Combined Gum-chewing and Parenteral Metoclopramide on Post-operative Ileus
Condition: Ileus Postoperative
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 4

Summary: 
      A delay in the return of bowel function is a common occurrence after abdominal surgeries.1
      The goal of this study was to test the effect of the combined use of chewing a gum and
      administering metoclopramide intravenously on the duration of this natural delay in the
      return of bowel function after abdominal surgeries. Patients were grouped into four: the
      first group received both gum and metoclopramide; the second group received only gum; the
      third group received only metoclopramide, while the fourth group (the control group) received
      sterile water for injection. The groups were compared for the time taken for bowel function
      to return and the duration of hospital stay.
    

Detailed description: 
      This was a prospective randomized controlled trial that recruited all patients requiring
      elective abdominal surgery, aged 16-65years. Abdominal emergency surgeries and structural or
      functional inability to chew gum constituted the exclusion criteria. A written informed
      consent was obtained from all eligible patients.

      Considering an effect size of 0.8(Cohen, 1962)2 at a power of 80% with 95% level of
      confidence and type-1 error of 5%, a total sample size of 105 study participants was
      obtained, having considered an attrition rate of 5%. Study participants were randomized into
      4 groups (a gum-metoclopramide {GM} group, a gum-only {G} group, a metoclopramide-only {M}
      group and a control {C} group) using blocked sequence randomization.

      Data was obtained through a detailed history and physical examination and include demographic
      variables like age and gender. Medical history of previous abdominal surgeries and any
      comorbidity like chronic constipation, diabetes mellitus, parkinsonism, renal or cardiac
      disease were sought and allergy to metoclopramide or gum noted. Body Mass Index (BMI) and
      relevant investigation results were recorded. Other pre- and intra-operative data recorded
      included: clinical diagnosis, American Society of Anaesthesiologists (ASA) grade, type of
      anaesthesia, cadre of surgeon, surgical access (laparoscopic versus open), length of skin
      incision, intra-operative blood loss, total intra-operative fluid administered, duration of
      surgery, surgical procedure done and duration of anaesthesia. Recorded post-operatively were
      time to passage of first flatus, time to passage of first feces, time to initial recording of
      bowel sounds, time to tolerance of normal diet, day of first ambulation, length of hospital
      stay, cost of hospital stay and post-operative complications.

      Informed consent was obtained from all patients that met the inclusion criteria. All patients
      for elective surgery were admitted at least a day prior to surgery and kept on nothing by
      mouth from 12midnight on the eve of surgery. Patients were given intravenous metronidazole
      and ceftriaxone at the induction of anaesthesia. All the patients had general anaesthesia.
      Abdominal skin incision was made by the surgeon who was either a senior registrar or
      consultant in general surgery and to whom the patient's group was undisclosed. Standard
      procedures (surgical and anesthetic) relevant for each case were carried out. The group
      assigned to each patient was known only to the research assistants (a house surgeon and the
      nursing staff) who alone administered the intervention to the appropriate groups. Although
      what was used for intravenous intervention was undisclosed to the patients in the GM, M and C
      groups, it was not possible to blind patients who received gum only (G group).

      All interventions were commenced from the 1st post-operative day. Patients in the gum-only(G)
      group were given one stick of sugar free gum (Orbit, Wrigley, US) 3 times 8 hourly daily (in
      the morning, afternoon and in the evening) till either first flatus or feces was passed with
      an instruction to chew for 15 minutes(only) without swallowing the chewed gum. The criteria
      for discontinuing each intervention was not disclosed to the patients. The gum was given to
      patients at a fixed interval to help monitor compliance. Patients in the metoclopramide-only
      (M) group received intravenous metoclopramide (Philometro, Hubei Tianyao) 10mg 8hourly for
      the first 72hours post-operatively. The gum-metoclopramide (GM) group received intravenous
      metoclopramide and also chewed gum using the protocol earlier described for gum only and
      metoclopramide only groups. Patients assigned to the control (C) group received 10ml of
      sterile water intravenously 8hourly for the first 72hours post-operatively.

      All patients were asked to notify the nursing staff at first passage of flatus. A blinded
      doctor visited the patients 8hourly and recorded the time of the first bowel sounds, passage
      of flatus, and defecation. After giving each intervention, the type and time of intervention
      was documented in an identifier-free patient's questionnaire. The first time of flatus and
      defecation was recorded based on the patient's own statements. Prolonged post-operative ileus
      was defined as ileus lasting more than 5days following laparotomy or greater than 3days
      following laparoscopic surgery.3 Nasogastric tube was removed on the day of return of bowel
      function. The total duration of hospital stay, calculated from the first post-operative day
      to the day of discharge, was recorded.

      The association between categorical and numerical peri-operative factors with prolonged
      post-operative ileus was analyzed using the Chi-square (and Fisher's exact) test and
      independent t-test (and Mann Whitney-U test) respectively. Comparison of groups in terms of
      the duration of post-operative ileus and duration of hospital stay was done using analysis of
      variance (ANOVA). Secondary endpoints compared between the groups included time to first
      bowel sound, duration of hospital stay and cost of hospital stay. Statistical significance
      was set at a p-value of <0.05. Version 23 of the Statistical Package for Social Sciences for
      Windows was used to analyze all data obtained from this study.
    

Intervention name(s): Metoclopramide 10mg; Gum and metoclopramide; Gum; Control
Intervention type(s): Drug; Combination Product; Other; Other
Intervention description(s): Intravenous metoclopramide 10mg 8hourly for the first 72hours post-operatively; Intravenous metoclopramide 10mg 8hourly for the first 72hours post-operatively and one stick of sugar-free gum (over 15minutes) 8 hourly till either the first flatus or feces was passed; One stick of sugar-free gum (over 15minutes) 8 hourly till either the first flatus or feces was passed; 10ml of sterile water intravenously 8hourly for the first 72hours post-operatively
Other intervention name(s): Philometro, Hubei Tianyao
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Patients were randomized into a gum-metoclopramide (GM) group, a gum-only (G) group, a metoclopramide-only (M) group and a control (C) group. Patients in the GM group chewed gum and received intravenous metoclopramide, each 8 hourly. In the G group, patients chewed only gum while those in the M group received 10mg of intravenous metoclopramide only. To the C group, 10ml of intravenous sterile water for injection was given 8 hourly
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Gum-chewing; Metoclopramide; Abdominal; Surgery