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

E

Erzincan Military Hospital

Status and phase

Unknown
Phase 4

Conditions

Postoperative Ileus

Treatments

Drug: gum

Study type

Interventional

Funder types

Other

Identifiers

NCT01835119
gungorduk14

Details and patient eligibility

About

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.

Enrollment

152 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

152 participants in 2 patient groups

chewing gum
Experimental group
Description:
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.
Treatment:
Drug: gum
control group
No Intervention group
Description:
no gum

Trial contacts and locations

1

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Central trial contact

Egemen Ertas, M.D; Aykut Ozdemir, M.D

Data sourced from clinicaltrials.gov

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