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Postoperative Chewing Gum and Gynecological Laparoscopic Surgery

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

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.

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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


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



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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884244


Locations
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Turkey
Pınar Kadiroğulları
Istanbul, Turkey, 33403
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
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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    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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