Cesarean Sectioncs adhesionsNCT01183000
Closure of Peritoneum at Cesarean Section and Postoperative Adhesion
A study testing Closure of the peritoneum at cs in people with Cesarean Section and Adhesions, run by Barzilai Medical Center at 2 sites in Israel.
Trial summary
Objective: To determine the effect of non-closure of the visceral and parietal peritoneum during Cesarean section on the formation of adhesions. Study design: A prospective randomized trial of 533 women undergoing primary Cesarean section; 256 were randomized to non closure and 277 to closure of the peritoneum. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Adhesions
- What is being tested?
- Closure of the peritoneum at cs
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 2 sitesIsrael
- Study dates
- 16 Jan 2010to 31 Dec 2010
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing primary CS
Who cannot join
- Lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent
- Previous pelvic or abdominal surgery
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Barzilai Medical Center
Ashkelon, 78306
Barzilay University Medical Center
Ashkelon
About this study
Official title: Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study
Objective: To determine the effect of non-closure of the visceral and parietal peritoneum during Cesarean section on the formation of adhesions.
Study design: A prospective randomized trial of 533 women undergoing primary Cesarean section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a subsequent cesarean,he presence of adhesions and their severity was evaluated at several sites: between the layers of the abdominal wall, between the bladder and the abdominal wall, between bladder and uterus, between the uterus and the abdominal wall, and between the bowels and the pelvic organs. A cumulative adhesion score was calculated.
- Conditions
- Cesarean Section, Adhesions
- Being tested
- Closure of the peritoneum at cs
- Keywords
- Formation of adhesions assessed at subsequent cs
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the peritoneum at csProcedure or surgery
Injection of 5 mg Marcaine (anesthetic solution) to the leg
| Study group | Role | What they receive |
|---|---|---|
| peritoneal closure | Active comparator | Not described Receives: Procedure: Closure of the peritoneum at cs |
| Non closure of the peritoneum | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion score
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study start16 Jan 2010
- Primary completion16 Aug 2010
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ofer gemer, Barzilai Medical Center
- Investigators
- Ofer Gemer, MD, Principal investigator, Barzili Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183000
- Sponsor's protocol ID
- 1789
- Acronym
- cs adhesions
- Status last verified
- Jul 2019
- First submitted
- 8 Aug 2010
- Last updated
- 12 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01183000
- Acronym / sponsor ID
- cs adhesions / 1789
- Conditions
- Cesarean Section, Adhesions
- Keywords
- Formation of adhesions assessed at subsequent cs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 16 Jan 2010 (actual)
- Primary completion
- 16 Aug 2010 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 17 Aug 2010 (estimated)
- 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.
Objective: To determine the effect of non-closure of the visceral and parietal peritoneum during Cesarean section on the formation of adhesions.
Study design: A prospective randomized trial of 533 women undergoing primary Cesarean section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a subsequent cesarean,he presence of adhesions and their severity was evaluated at several sites: between the layers of the abdominal wall, between the bladder and the abdominal wall, between bladder and uterus, between the uterus and the abdominal wall, and between the bowels and the pelvic organs. A cumulative adhesion score was calculated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peritoneal closure | Active comparator | Procedure: Closure of the peritoneum at cs |
| Non closure of the peritoneum | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing primary CS
Key exclusion criteria (2 listed)
- Lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent
- Previous pelvic or abdominal 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 |
|---|---|---|
| Closure of the peritoneum at csInjection of 5 mg Marcaine (anesthetic solution) to the leg | Procedure or surgery | peritoneal closure |
Primary outcome
Adhesion score
Time frame: 6 years
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 12 Jul 2019.
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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.
Ofer Gemer, MD principal investigator
Barzili Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of the peritoneum at cs in people with Cesarean Section and Adhesions, run by Barzilai Medical Center at 2 sites in Israel.
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 2 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Adhesion score (time frame: 6 years). 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 12 Jul 2019.