Gynecologic DiseaseNCT03884244
Postoperative Chewing Gum and Gynecological Laparoscopic Surgery
A study testing chewing gum in people with Gynecologic Disease and Postoperative Ileus, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Gynecologic Disease, Postoperative Ileus, Paralytic Ileus
- What is being tested?
- chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective laparoscopic gynecological surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Postoperative Chewing Gum on Intestinal Functions After Gynecological Laparoscopic Surgery
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.
- Conditions
- Gynecologic Disease, Postoperative Ileus, Paralytic Ileus
- Being tested
- chewing gum
- Keywords
- Laparoscopic Surgery, Postoperative Bowel Function
- Medical subject headings
- Genital Diseases, Female, Intestinal Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gumOther
The group who take chewing gum after operation
| Study group | Role | What they receive |
|---|---|---|
| taking chewing gum patients | Active comparator | Not described Receives: Other: chewing gum |
| no chewing gum | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative first 1440 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884244
- Sponsor's protocol ID
- 2018.10.21
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2019
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative Chewing Gum on Intestinal Functions After Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03884244
- Acronym / sponsor ID
- 2018.10.21
- Conditions
- Gynecologic Disease, Postoperative Ileus, Paralytic Ileus
- Keywords
- Laparoscopic Surgery, Postoperative Bowel Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taking chewing gum patients | Active comparator | Other: chewing gum |
| no chewing gum | No intervention | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective laparoscopic gynecological surgery.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chewing gumThe group who take chewing gum after operation | Other | taking chewing gum patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chewing gum in people with Gynecologic Disease and Postoperative Ileus, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Bowel Functions (time frame: Postoperative first 1440 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.