Sterility, PostpartumPhase 3NCT03429621
Effect of Simethicone on Reducing Bowel Interference During Tubal Resection
A Phase 3 study testing Simethicone 80 MG in people with Sterility, Postpartum, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Tubal ligation is an everyday procedure for permanent female sterilization. It is usually performed after a vaginal delivery. Minilaparotomy is generally performed by doing small incision at infraumbilical area. This minimal access surgery requires adequate operative field exposure. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sterility, Postpartum
- What is being tested?
- Simethicone 80 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 8 Mar 2018to 31 Mar 2019
- Phase
- Phase 3
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women requesting postpartum sterilization by minilaparotomic tubal resection after vaginal delivery at Faculty of Medicine, Chiang Mai University
Who cannot join
- Pre-pregnancy BMI > 25 kg/m2
- Intraoperative general anesthesia or epidural anesthesia
- Previous abdominal surgery except for appendectomy
- Known bowel disorder including Crohn's disease, ulcerative colitis, previous bowel surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
About this study
Official title: Effect of Simethicone on Reducing Bowel Interference During Minilaparotomy for Tubal Resection : a Randomized Controlled Trial
Tubal ligation is an everyday procedure for permanent female sterilization. It is usually performed after a vaginal delivery. Minilaparotomy is generally performed by doing small incision at infraumbilical area. This minimal access surgery requires adequate operative field exposure. Bowel interference, which obscures visualization of the operative field has been recognized as one of the major obstacles during this procedure. We found problems while doing surgery in small space and one of them is bowel interferance which obscures vision. This could lead to prolonged operation and complications. Simethicone is an antifoaming agent that use in bowel preparation prior to various procedures including laparoscopy, colonoscopy, endoscopy, and open major abdominal operations. Simethicone is proven to break the bubble and reduce intraluminal gas. This effect could result in reduction of bowel dilatation that interfere with the proper identification of the adnexal area. Benefit of taking simethicone prior to do minilaparotomy for tubal resection has not been examined.
Objectives: To examine the effect of simethicone on reducing bowel interference during minilaparotomy for tubal resection.
Design: A randomized controlled trial in women, age 20-45 years, undergoing postpartum sterilization after vaginal delivery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (taking simethicone) and control (not taking simethicone). For the intervention group, each woman will take simethicone (80 mg) 2 tablet chewing with water 50 ml at 2-8 hours before surgery. Fasting at least 6 hours before surgery. For the control group, the women will receive the same standard perioperative care without taking simethicone. The primary outcome measure will be surgeon-rated operative difficulty score, which is a visual analog scale based on assess from exposure of to the operative field in visual analog scale by surgeon. The secondary outcome will be operative time and incidence of intraoperative and postoperative complications.
- Conditions
- Sterility, Postpartum
- Being tested
- Simethicone 80 MG
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone 80 MGDrug
Simethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Simethicone | Experimental | Each woman in the intervention group will be given Simethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery. Receives: Drug: Simethicone 80 MG |
| No simethicone | No intervention | The women will not be given Simethicone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative difficulty score
Operative difficulty scores will be assessed at the end of the operation by the operating surgeon. The surgeon will rate the difficulty of the operation from 0 to 10 according to the 10-cm visual analog scale with "0" represents the easiest operation and "10" represents the hardest operation.
Measured: At the end of operation (within 1 hour after the completion of the operation)
Secondary outcomes (2)
Operation time (Total)
The time duration from skin incision to completion of skin closure
Measured: From the start of skin incision creation to the completion of skin closure (up to 2 hours)
Operation time (Intraabdominal)
The time duration from first entering abdominal cavity to start closing the abdominal peritoneum.
Measured: From first entering abdominal cavity to start closing the abdominal peritoneum (up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start8 Mar 2018
- Primary completion28 Feb 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sterility, PostpartumStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipat Charoenkwan, MD, Chiang Mai University
- Investigators
- Kittipat Charoenkwan, MD, MSc, Principal investigator, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429621
- Sponsor's protocol ID
- OBG-2560-05148
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2018
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simethicone on Reducing Bowel Interference During Minilaparotomy for Tubal Resection : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03429621
- Acronym / sponsor ID
- OBG-2560-05148
- Conditions
- Sterility, Postpartum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 12 Feb 2018 (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.
Tubal ligation is an everyday procedure for permanent female sterilization. It is usually performed after a vaginal delivery. Minilaparotomy is generally performed by doing small incision at infraumbilical area. This minimal access surgery requires adequate operative field exposure. Bowel interference, which obscures visualization of the operative field has been recognized as one of the major obstacles during this procedure. We found problems while doing surgery in small space and one of them is bowel interferance which obscures vision. This could lead to prolonged operation and complications. Simethicone is an antifoaming agent that use in bowel preparation prior to various procedures including laparoscopy, colonoscopy, endoscopy, and open major abdominal operations. Simethicone is proven to break the bubble and reduce intraluminal gas. This effect could result in reduction of bowel dilatation that interfere with the proper identification of the adnexal area. Benefit of taking simethicone prior to do minilaparotomy for tubal resection has not been examined.
Objectives: To examine the effect of simethicone on reducing bowel interference during minilaparotomy for tubal resection.
Design: A randomized controlled trial in women, age 20-45 years, undergoing postpartum sterilization after vaginal delivery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (taking simethicone) and control (not taking simethicone). For the intervention group, each woman will take simethicone (80 mg) 2 tablet chewing with water 50 ml at 2-8 hours before surgery. Fasting at least 6 hours before surgery. For the control group, the women will receive the same standard perioperative care without taking simethicone. The primary outcome measure will be surgeon-rated operative difficulty score, which is a visual analog scale based on assess from exposure of to the operative field in visual analog scale by surgeon. The secondary outcome will be operative time and incidence of intraoperative and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simethicone | Experimental | Drug: Simethicone 80 MGEach woman in the intervention group will be given Simethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery. |
| No simethicone | No intervention | –The women will not be given Simethicone. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women requesting postpartum sterilization by minilaparotomic tubal resection after vaginal delivery at Faculty of Medicine, Chiang Mai University
Key exclusion criteria (4 listed)
- Pre-pregnancy BMI > 25 kg/m2
- Intraoperative general anesthesia or epidural anesthesia
- Previous abdominal surgery except for appendectomy
- Known bowel disorder including Crohn's disease, ulcerative colitis, previous bowel surgery
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 |
|---|---|---|
| Simethicone 80 MGSimethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery | Drug | Simethicone |
Primary outcome
Operative difficulty score
Time frame: At the end of operation (within 1 hour after the completion of the operation)
Operative difficulty scores will be assessed at the end of the operation by the operating surgeon. The surgeon will rate the difficulty of the operation from 0 to 10 according to the 10-cm visual analog scale with "0" represents the easiest operation and "10" represents the hardest operation.
2 secondary outcomes
Operation time (Total)
Time frame: From the start of skin incision creation to the completion of skin closure (up to 2 hours)
Operation time (Intraabdominal)
Time frame: From first entering abdominal cavity to start closing the abdominal peritoneum (up to 2 hours)
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 5 Feb 2020.
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.
Kittipat Charoenkwan, MD, MSc principal investigator
Faculty of Medicine, Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simethicone 80 MG in people with Sterility, Postpartum, run by Chiang Mai University at 1 site in Thailand.
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 4 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 5 Feb 2020. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Operative difficulty score (time frame: At the end of operation (within 1 hour after the completion of the operation)). 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 5 Feb 2020.