Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies
|ClinicalTrials.gov Identifier: NCT01835119|
Recruitment Status : Unknown
Verified April 2013 by Kemal GUNGORDUK, Erzincan Military Hospital.
Recruitment status was: Recruiting
First Posted : April 18, 2013
Last Update Posted : April 18, 2013
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 or disease||Intervention/treatment||Phase|
|Postoperative Ileus||Drug: gum||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||April 2013|
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.
No Intervention: control group
- postoperative flatus pass time [ Time Frame: an expected average of 48 hours ]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
- duration of hospital stay [ Time Frame: an expected average of 3 weeks ]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 ]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 ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835119
|Contact: Egemen Ertas, M.D||90 232 449 49 email@example.com|
|Contact: Aykut Ozdemir, M.D||90 232 449 49 firstname.lastname@example.org|
|İzmir Tepecik training and research hospital||Recruiting|
|İzmir, Tepecik, Turkey, 35120|
|Contact: Egmen Ertas, email@example.com 90 232 449 49 49 firstname.lastname@example.org|