Postoperative Chewing Gum and Gynecological Laparoscopic Surgery

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03884244

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The authors aimed to evaluate the effects of postoperative gum chewing on laparoscopic gynecological surgery, gastrointestinal function-intestinal mobility and early postoperative recovery. Patients undergoing elective gynecological laparoscopy were randomized. Demographic and characteristic features of the patients were recorded. Operation type, operation and anesthesia information were recorded. Patients underwent a postoperative routine regimen. Starting from the sixth hour, the sugar-free gum was crushed every 15 minutes until the gas was released. Postoperative follow-up was performed routinely. The first bowel movements, first bowel movements and first gas extraction and first decongestation periods were recorded.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Disease Postoperative Ileus Paralytic Ileus	Other: chewing gum	N/A

Detailed Description

The team of the research team of the research team will listen and record the bowel sounds of the patients, using a stethoscope every two hours starting from the postoperative 3rd hour until the first bowel sounds are heard in each patient.

Patients who were able to tolerate patients starting from the 8th hour after the surgery were allowed for mobilization. Also, they were allowed to take fluid regimen from the postoperative 12th hour. Patient satisfaction was evaluated by using visual analogue scale (VAS) on the day of discharge on chewing postoperative.

The primary index for the return of GI functions was the first gas removal time. Secondary index was the time of first bowel sound, the first time of admission, hospitalization time and the presence of postoperative ileus.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Postoperative Chewing Gum on Intestinal Functions After Gynecological Laparoscopic Surgery

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: taking chewing gum patients	Other: chewing gum The group who take chewing gum after operation
No Intervention: no chewing gum

Arm

Intervention/Treatment

Active Comparator: taking chewing gum patients

Other: chewing gum

The group who take chewing gum after operation

No Intervention: no chewing gum

Outcome Measures

Primary Outcome Measures

Postoperative Bowel Functions [Postoperative first 1440 minutes]
The Effect of Postoperative Chewing Gum on Intestinal Functions after Gynecological Laparoscopic Surgery ; The primary index for the return of GI functions was the first gas removal time. Patient first extraction of gas, recorded in minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing elective laparoscopic gynecological surgery.

Exclusion Criteria:

Those who have been operated for malignant reasons,
Those who underwent emergency surgery,
Who could not chew gum,
Who had serious surgical complications (postoperative intraabdominal hemorrhage, infection, peritonitis),
Who had a history of gastrointestinal disease,
Secondary laparotomy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pınar Kadiroğulları	Istanbul		Turkey	33403

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pınar Kadirogulları, principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT03884244

Other Study ID Numbers:

2018.10.21

First Posted:

Mar 21, 2019

Last Update Posted:

Mar 21, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pınar Kadirogulları, principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital

Laparoscopic Surgery

Postoperative Bowel Function

Additional relevant MeSH terms:

Ileus

Intestinal Pseudo-Obstruction

Study Results

No Results Posted as of Mar 21, 2019