Suturing of Rectus Muscle at Cesarean SectionNCT05260970
The Effect of Rectus Muscle Re-approximation at Cesarean Delivery on Postoperative Pain
An observational study of Suturing of Rectus Muscle at Cesarean Section, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Rectus Muscle Re-approximation on Postoperative Pain Among Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section: A Randomized Prospective Trial. Cesarean section is the most common surgical procedure performed in women in all around the world. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Suturing of Rectus Muscle at Cesarean Section
- What is being tested?
- Rectus muscle reapproximation at cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Apr 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This study is a prospective, randomized controlled trial conducted at Balikesir University, Department of Obstetrics and Gynecology at Balikesir Turkey. Pregnant women undergoing elective first cesarean section who were not in labor and consented to the trial were randomly assigned to receive rectus muscle reapproximation versus no reapproximation.
Who may be able to join
- Primigravida pregnancies
- Singleton pregnancies
- Aged between 18- 45
- Term pregnancy
- First cesarean section
- Elective
- Without any comorbidity (Thyroid disorders, Diabetes Mellitus, Hypertension, Preterm delivery, etc.)
Who cannot join
- active labor,
- Prior cesarean section
- chronic analgesia use,
- vertical skin incision at cesarean,
- allergy to opioid or nonsteroidal anti-inflammatory drugs (NSAIDs),
- prior laparotomy,
- class III obesity (body mass index above 40).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Balikesir University Medical Faculty Department of Obstetrics and Gynecology
Balıkesir, 65080
Orkun Çetin, 05325910205, drorkuncetin34@hotmail.com
About this study
Official title: The Effect of Rectus Muscle Re-approximation on Postoperative Pain Among Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section: A Randomized Prospective Trial
The Effect of Rectus Muscle Re-approximation on Postoperative Pain Among Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section: A Randomized Prospective Trial.
Cesarean section is the most common surgical procedure performed in women in all around the world. Cesarean delivery rate has increased dramatically worldwide but there is still debate about the optimum operative technique of cesarean section.
Read more
Rectus muscle reapproximation, or suturing of the rectus muscles, is performed by many obstetricians in several countries, presumably to reduce the risk of persistent rectus muscle diastasis. However, there was a few studies about the short and long term effects of rectus muscle reapproximation in the literature.
On this account, the investigators aimed to design a randomized prospective trial about the effect of rectus muscle re-approximation on postoperative pain among primigravida singleton pregnancies who underwent elective cesarean section.
Read the detailed description
This study is a prospective, randomized controlled trial conducted at Balikesir University Medical Faculty Department of Obstetrics and Gynecology at Balikesir, Turkey between January 2021 and March 2022. The singleton pregnant women undergoing scheduled primary cesarean section who are not in labor and consented to the trial are randomly assigned to receive rectus muscle reapproximation versus no reapproximation.
Gestational age is detected by the first day of last menstrual period and confirmed by first trimester ultrasonography measurements. The pregnant women who recruited this study would have no maternal accompanying conditions, such as hypertensive disorders of pregnancy, preterm rupture of membranes, Type 1 diabetes mellitus, gestational diabetes mellitus, reno-vascular disorders, sickle-cell anemia, collagen-vascular diseases, hereditary or acquired thrombophilia, congenital abnormalities and multiple gestations. Randomization would be conducted through sequentially numbered opaque envelopes generate by a study nurse in blocks through a random numbers table, in a 1:1 ratio.
Surgical techniques at cesarean section are standardized within the study and included closure of the parietal peritoneum and one-layer uterine closure. For women randomized to rectus muscle reapproximation, surgeons will use 2.0 Vicryl (Ethicon) for continuous suturing to reapproximate the rectus muscles. All surgeries were performed by an attending physician and a resident physician.Intraoperative analgesia was standardized to spinal anesthesia. Postoperative pain management is standardized by using our clinic's postoperative cesarean section protocol.Patients with pain unresponsive to the aforementioned treatment could receive opioids as necessary. Visual analog scale (VAS)scores are assessed through inperson interview in the hospital by a member of the study team at 24 and 48 hours after cesarean section.Total opioid use, total milligrams of nonsteroid antiinflammatory drugs (NSAIDs) and acetaminophen use are also tracked and summed.
The primary outcome will be the changes in total NSAID, opioid and acetaminophen use of the patients between the groups (rectus reapproximation and no rectus reapproximation groups). The investigators will also analyze the VAS scores of the patients 24 and 48 hours after surgery between the groups.
- Being tested
- Rectus muscle reapproximation at cesarean section
- Keywords
- Cesarean section, Rectus Muscle, Rectus Muscle Re-approximation, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus muscle reapproximation at cesarean sectionProcedure or surgery
Rectus muscle reapproximation: Continuous Suturing of rectus muscles with 2.0 Vicryl (Ethicon) at Cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| undergoing rectus muscle reapproximation | Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section with rectus muscle reapproximation procedure Receives: Procedure: Rectus muscle reapproximation at cesarean section | |
| not undergoing rectus muscle reapproximation | Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section without rectus muscle reapproximation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Drugs (mg)
Measured: postoperative period first 48 hours.
Operation time
Operation time: Hours
Measured: During operation
Changes in hemoglobin level
mg/dl
Measured: Intraoperative and postoperative period (including postoperative 48 hours)
Length of hospital stay
Length of hospital stay: Days
Measured: Throughout postoperative period, an average of 2 days after surgery
Occurence of postoperative complication
Hematoma, dehiscense, blood transfusion, etc.
Measured: Throughout postoperative period, an average of 7 days after surgery
Postoperative pain
Visual Analog Scale Score: Units on a Scale (minimum score: 1- maximum score: 100)
Measured: Visual analog score of the patient after 24 hours after cesarean section
Postoperative pain
Visual Analog Scale Score: Units on a Scale (minimum score: 1- maximum score: 100)
Measured: Visual analog score of the patient after 48 hours after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jan 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suturing of Rectus Muscle at Cesarean SectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Cetin, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260970
- Sponsor's protocol ID
- rectus1
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No: There is not a plan to make IPD available.
Publications
Cetin O, Ak K, Sahin TB, Cetin ID. Rectus muscle re-approximation in cesarean section - a surgical dilemma: to close or not to close? Ginekol Pol. 2024;95(10):819-823. doi: 10.5603/gpl.98027. Epub 2024 May 8.
PubMed 38717223
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rectus Muscle Re-approximation on Postoperative Pain Among Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT05260970
- Acronym / sponsor ID
- rectus1
- Keywords
- Cesarean section, Rectus Muscle, Rectus Muscle Re-approximation, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 2 Mar 2022 (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 Effect of Rectus Muscle Re-approximation on Postoperative Pain Among Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section: A Randomized Prospective Trial.
Cesarean section is the most common surgical procedure performed in women in all around the world. Cesarean delivery rate has increased dramatically worldwide but there is still debate about the optimum operative technique of cesarean section.
Rectus muscle reapproximation, or suturing of the rectus muscles, is performed by many obstetricians in several countries, presumably to reduce the risk of persistent rectus muscle diastasis. However, there was a few studies about the short and long term effects of rectus muscle reapproximation in the literature.
On this account, the investigators aimed to design a randomized prospective trial about the effect of rectus muscle re-approximation on postoperative pain among primigravida singleton pregnancies who underwent elective cesarean section.
Detailed description
This study is a prospective, randomized controlled trial conducted at Balikesir University Medical Faculty Department of Obstetrics and Gynecology at Balikesir, Turkey between January 2021 and March 2022. The singleton pregnant women undergoing scheduled primary cesarean section who are not in labor and consented to the trial are randomly assigned to receive rectus muscle reapproximation versus no reapproximation.
Gestational age is detected by the first day of last menstrual period and confirmed by first trimester ultrasonography measurements. The pregnant women who recruited this study would have no maternal accompanying conditions, such as hypertensive disorders of pregnancy, preterm rupture of membranes, Type 1 diabetes mellitus, gestational diabetes mellitus, reno-vascular disorders, sickle-cell anemia, collagen-vascular diseases, hereditary or acquired thrombophilia, congenital abnormalities and multiple gestations. Randomization would be conducted through sequentially numbered opaque envelopes generate by a study nurse in blocks through a random numbers table, in a 1:1 ratio.
Surgical techniques at cesarean section are standardized within the study and included closure of the parietal peritoneum and one-layer uterine closure. For women randomized to rectus muscle reapproximation, surgeons will use 2.0 Vicryl (Ethicon) for continuous suturing to reapproximate the rectus muscles. All surgeries were performed by an attending physician and a resident physician.Intraoperative analgesia was standardized to spinal anesthesia. Postoperative pain management is standardized by using our clinic's postoperative cesarean section protocol.Patients with pain unresponsive to the aforementioned treatment could receive opioids as necessary. Visual analog scale (VAS)scores are assessed through inperson interview in the hospital by a member of the study team at 24 and 48 hours after cesarean section.Total opioid use, total milligrams of nonsteroid antiinflammatory drugs (NSAIDs) and acetaminophen use are also tracked and summed.
The primary outcome will be the changes in total NSAID, opioid and acetaminophen use of the patients between the groups (rectus reapproximation and no rectus reapproximation groups). The investigators will also analyze the VAS scores of the patients 24 and 48 hours after surgery between the groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| undergoing rectus muscle reapproximation | – | Procedure: Rectus muscle reapproximation at cesarean sectionPrimigravida Singleton Pregnancies Who Underwent Elective Cesarean Section with rectus muscle reapproximation procedure |
| not undergoing rectus muscle reapproximation | – | –Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section without rectus muscle reapproximation procedure |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study is a prospective, randomized controlled trial conducted at Balikesir University, Department of Obstetrics and Gynecology at Balikesir Turkey. Pregnant women undergoing elective first cesarean section who were not in labor and consented to the trial were randomly assigned to receive rectus muscle reapproximation versus no reapproximation.
Key inclusion criteria (7 listed)
- Primigravida pregnancies
- Singleton pregnancies
- Aged between 18- 45
- Term pregnancy
- First cesarean section
Key exclusion criteria (7 listed)
- active labor,
- Prior cesarean section
- chronic analgesia use,
- vertical skin incision at cesarean,
- allergy to opioid or nonsteroidal anti-inflammatory drugs (NSAIDs),
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 |
|---|---|---|
| Rectus muscle reapproximation at cesarean sectionRectus muscle reapproximation: Continuous Suturing of rectus muscles with 2.0 Vicryl (Ethicon) at Cesarean section. | Procedure or surgery | undergoing rectus muscle reapproximation |
Primary outcome
Postoperative analgesia
Time frame: postoperative period first 48 hours.
Drugs (mg)
Operation time
Time frame: During operation
Operation time: Hours
Changes in hemoglobin level
Time frame: Intraoperative and postoperative period (including postoperative 48 hours)
mg/dl
Length of hospital stay
Time frame: Throughout postoperative period, an average of 2 days after surgery
Length of hospital stay: Days
Occurence of postoperative complication
Time frame: Throughout postoperative period, an average of 7 days after surgery
Hematoma, dehiscense, blood transfusion, etc.
Postoperative pain
Time frame: Visual analog score of the patient after 24 hours after cesarean section
Visual Analog Scale Score: Units on a Scale (minimum score: 1- maximum score: 100)
Postoperative pain
Time frame: Visual analog score of the patient after 48 hours after cesarean section
Visual Analog Scale Score: Units on a Scale (minimum score: 1- maximum score: 100)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 38717223Cetin O, Ak K, Sahin TB, Cetin ID. Rectus muscle re-approximation in cesarean section - a surgical dilemma: to close or not to close? Ginekol Pol. 2024;95(10):819-823. doi: 10.5603/gpl.98027. Epub 2024 May 8.
- Individual participant dataSharing planned: No. No: There is not a plan to make IPD available.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suturing of Rectus Muscle at Cesarean Section, run by Balikesir University 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orkun Çetin (05325910205, drorkuncetin34@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: postoperative period first 48 hours.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260970, which also lists 1 linked publication.
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 2 Mar 2022.