Postoperative Chewing Gum and Gynecological Laparoscopic Surgery

• ClinicalTrials.gov Identifier: NCT03884244
• Recruitment Status: Completed
• First Posted: March 21, 2019
• Last Update Posted: March 21, 2019
• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Information provided by (Responsible Party): Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

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	Not Applicable

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 (Clinical Trial)
• 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: March 1, 2018
• Actual Primary Completion Date: March 1, 2019
• Actual Study Completion Date: March 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

Outcome Measures

Primary Outcome Measures :

1. Postoperative Bowel Functions [ Time Frame: 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

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Turkey

Pınar Kadiroğulları

Istanbul, Turkey, 33403

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

More Information

• 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: March 21, 2019
• Last Update Posted: March 21, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital:

Laparoscopic Surgery; Postoperative Bowel Function

Additional relevant MeSH terms:

Ileus; Intestinal Pseudo-Obstruction; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases