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CompletedNCT03884244Updated Jul 18, 2024

Postoperative Chewing Gum and Gynecological Laparoscopic Surgery

An interventional study of chewing gum in Gynecologic Disease, Postoperative Ileus and Paralytic Ileus, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Gynecologic Disease
  • Postoperative Ileus
  • Paralytic Ileus

Keywords

  • Laparoscopic Surgery
  • Postoperative Bowel Function
03

In context

Genital Diseases, Female

161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.

This study's enrollment of 200 is above the median of 78 across 119 interventional studies indexed under Genital Diseases, Female.

Browse Genital Diseases, Female studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 225 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing elective laparoscopic gynecological surgery.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    taking chewing gum patients

    Other: chewing gum

  • No intervention
    no chewing gum

Interventions

  • Otherchewing gum

    The group who take chewing gum after operation

06

What researchers measure

Primary outcomes

  1. Postoperative Bowel Functions

    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.

    Time frame: Postoperative first 1440 minutes

07

Study locations

1 site
  • Pınar Kadiroğulları
    Istanbul, 33403, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03884244
Responsible party
Pınar Kadirogulları (principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Mar 21, 2019
Start date
Mar 1, 2018
Primary completion
Mar 1, 2019
Completion
Mar 1, 2019
Last update
Jul 18, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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