Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Erzincan Military Hospital
Sponsor:
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital
ClinicalTrials.gov Identifier:
NCT01835119
First received: April 10, 2013
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

Postoperative ileus can cause the accumulation of secretions and gas, resulting in nausea, vomiting and abdominal distension and pain. Prolonged paralytic ileus is one of the commonest reasons for delayed recovery and discharge from hospital following abdominal surgery. Advances in surgical techniques and peri-operative management such as the use of laparoscopic surgery, thoracic epidural analgesia, early postoperative feeding and mobilization, amongst others, have been shown to help in the resolution of postoperative ileus.

Chewing gum, as a proxy for sham feeding, may accelerate the motility of the GI tract by stimulating the cephalic phase of digestion and eliciting the release of multiple promotility GI hormones. A number of small controlled studies evaluating the effect of chewing gum on postoperative intestinal recovery in patients undergoing colorectal surgery have been conducted. Decreased time for bowel function recovery and decreased hospital length of stay have not been consistently documented, possibly owing to the insufficient power of existing studies and study design issues. In addition, all previous studies have been limited by their use of sugarfree gum, containing known motility agents (eg, sorbitol).

In this study, gum chewing was studied for its effect on women with surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer.


Condition Intervention Phase
Postoperative Ileus
Drug: gum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies

Resource links provided by NLM:


Further study details as provided by Erzincan Military Hospital:

Primary Outcome Measures:
  • postoperative flatus pass time [ Time Frame: an expected average of 48 hours ] [ Designated as safety issue: Yes ]
    The main outcome variable of the study was postoperative flatus pass time (hours from end of operation). Participants will be followed for the duration of the flatus pass time, an expected average of 48 hours


Secondary Outcome Measures:
  • duration of hospital stay [ Time Frame: an expected average of 3 weeks ] [ Designated as safety issue: Yes ]
    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • gastrointestinal disturbance [ Time Frame: an expected average of 3 weeks ] [ Designated as safety issue: Yes ]
    gastrointestinal disturbance such as nausea, abdominal cramping, abdominal distension, rate of vomiting

  • time to first bowel movement [ Time Frame: an expected average of 48 hours hours from end of operation ] [ Designated as safety issue: Yes ]
    time to first bowel movement (hours from end of operation).Participants will be followed for time to first bowel movement, an expected average of 48 hours hours from end of operation

  • Time to first defaecation [ Time Frame: an expected average of 72 hours ] [ Designated as safety issue: Yes ]
    The main outcome variable of the study was postoperative flatus pass time (hours from end of operation).Participants will be followed for the duration of the first defaecation time, an expected average of 72 hours


Estimated Enrollment: 152
Study Start Date: January 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chewing gum

Gum type was standardized with all subjects receiving sugar-free peppermint-flavored gum.

The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (one stick) 3 times daily in the morning, afternoon, and evening at least 5 min. The administration of the therapy was implemented by ward nursing staff and recorded in the patients file. All gum-chewing patients completed their course of gum chewing until bowel function.

Drug: gum
gum
No Intervention: control group
no gum

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who would undergo surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer were assessed for eligibility.

Exclusion Criteria:

  • women who had thyroid diseases, inflammatory bowel disease, complaints of chronic constipation (defined as two or less bowel movements per week), had a history of prior abdominal bowel surgery, abdominal radiation, or neoadjuvant chemotherapy,
  • need for intensive care more that 24 hours postoperatively, had nasogastric tube drainage beyond the first postoperative morning bowel anastomosis in relation to their operation during the surgery
  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: NCT01835119

Contacts
Contact: Egemen Ertas, M.D 90 232 449 49 49 drertas@gmail.com
Contact: Aykut Ozdemir, M.D 90 232 449 49 49 isaaykutozdemir@yahoo.com

Locations
Turkey
İzmir Tepecik training and research hospital Recruiting
İzmir, Tepecik, Turkey, 35120
Contact: Egmen Ertas, drertas@gmail.com    90 232 449 49 49    drertas@gmail.com   
Sponsors and Collaborators
Erzincan Military Hospital
  More Information

No publications provided

Responsible Party: Kemal GUNGORDUK, Medical Doctor, Erzincan Military Hospital
ClinicalTrials.gov Identifier: NCT01835119     History of Changes
Other Study ID Numbers: gungorduk14
Study First Received: April 10, 2013
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration
Turkey: Ethics Committee
Turkey: Ministry of Health

Keywords provided by Erzincan Military Hospital:
gynecological malignancies
postoperative
bowel activity
gum chewing

Additional relevant MeSH terms:
Neoplasms
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 14, 2014