Intraperitoneal Adhesions After Rectus Muscles ApproximationNCT04548570
Closure vs Non Closure of Rectus Muscle at Cesarean Section 5 Year Study
An observational study of Intraperitoneal Adhesions After Rectus Muscles Approximation, run by Cairo University at 1 site in Egypt.
Trial summary
approximation of both recti during lower segment cesarean section may be an important step to lower incidence of intraabdominal adhesions . peritoneal adhesions are of major medical importance and are associated with clinical problems such as chronic pain and infertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intraperitoneal Adhesions After Rectus Muscles Approximation
- What is being tested?
- approximation of both rectus muscles
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to Aug 2022
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: patients who will subjected to cesarean section with history of previous cesarean section in the same hospital with operative notes and techniques
Who may be able to join
- all patients of first lower segment cs at kasr al ainy with previous recorded data including operative data, postoperative data including complications. all patients included in the study are elective cesarean section at 38 weeks of gestation
Who cannot join
- no history of infection or medical disease
- no history of previous laparotomies
- no history of pregnancy complications
- patients noted to have intraperitoneal adhesions in first cesarean section
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 02
hany saad, assistant prof, 01001817211, hanysaad25280@gmail.com
hadeer meshaal, ass prof, 01001435238, dr_hadeer@live.com
About this study
Official title: Closure vs Non Closure of Rectus Muscle at Cesarean Section Reducing Post Cesarean Adhesions
approximation of both recti during lower segment cesarean section may be an important step to lower incidence of intraabdominal adhesions . peritoneal adhesions are of major medical importance and are associated with clinical problems such as chronic pain and infertility.
Read the detailed description
all patients included in the study should be had the operative history of the previous cesarean section and were done in the cairo university and divid them into 2 groups. 1st group were both recti approximated while the second group were closed without approximating both recti. all patients will be subjected to lower segment cesarean segment to assess the intraperitoneal adhesions, mean operative time, mean hospital stay, postoperative distension, bowel sounds, postoperative infections and morbidity
- Being tested
- approximation of both rectus muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
approximation of both rectus musclesProcedure or surgery
closure of both rectus muscle before closure of rectus sheeth
| Study group | Role | What they receive |
|---|---|---|
| approximation of both recti group | Not described Receives: Procedure: approximation of both rectus muscles | |
| non approximation of both recti group | Not described Receives: Procedure: approximation of both rectus muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the intraperitoneal adhesions post rectus muscle closure
assessment of adhesions bands between the pelvic organs and bowel
Measured: intraoperative
Secondary outcomes (5)
mean operative time
calculate the mean time for closure of both recti
Measured: intraopertive time
mean hospital stay
assess the postoperative time of hospital stay
Measured: posoperative within first 48 hrs
mean postoperative bowel sounds
interval between operation and listening the bowel sounds
Measured: posoperative within 24 hrs
postoperative distension
assessment of bowel distension postoperative
Measured: posoperative within 24 hrs
postoperative morbidity and infections
assess the tempreture, scars
Measured: posoperative within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Jan 2020
- Primary completion1 Mar 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraperitoneal Adhesions After Rectus Muscles ApproximationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548570
- Sponsor's protocol ID
- assisstant professor
- Status last verified
- Jan 2022
- First submitted
- 19 May 2020
- Last updated
- 19 Jan 2022
- 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 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure vs Non Closure of Rectus Muscle at Cesarean Section Reducing Post Cesarean Adhesions
- ClinicalTrials.gov ID
- NCT04548570
- Acronym / sponsor ID
- assisstant professor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 14 Sep 2020 (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.
approximation of both recti during lower segment cesarean section may be an important step to lower incidence of intraabdominal adhesions . peritoneal adhesions are of major medical importance and are associated with clinical problems such as chronic pain and infertility.
Detailed description
all patients included in the study should be had the operative history of the previous cesarean section and were done in the cairo university and divid them into 2 groups. 1st group were both recti approximated while the second group were closed without approximating both recti. all patients will be subjected to lower segment cesarean segment to assess the intraperitoneal adhesions, mean operative time, mean hospital stay, postoperative distension, bowel sounds, postoperative infections and morbidity
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| approximation of both recti group | – | Procedure: approximation of both rectus muscles |
| non approximation of both recti group | – | Procedure: approximation of both rectus muscles |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients who will subjected to cesarean section with history of previous cesarean section in the same hospital with operative notes and techniques
Key inclusion criteria (1 listed)
- all patients of first lower segment cs at kasr al ainy with previous recorded data including operative data, postoperative data including complications. all patients included in the study are elective cesarean section at 38 weeks of gestation
Key exclusion criteria (4 listed)
- no history of infection or medical disease
- no history of previous laparotomies
- no history of pregnancy complications
- patients noted to have intraperitoneal adhesions in first cesarean section
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 |
|---|---|---|
| approximation of both rectus musclesclosure of both rectus muscle before closure of rectus sheeth | Procedure or surgery | approximation of both recti group, non approximation of both recti group |
Primary outcome
assessment of the intraperitoneal adhesions post rectus muscle closure
Time frame: intraoperative
assessment of adhesions bands between the pelvic organs and bowel
5 secondary outcomes
mean operative time
Time frame: intraopertive time
mean hospital stay
Time frame: posoperative within first 48 hrs
mean postoperative bowel sounds
Time frame: posoperative within 24 hrs
postoperative distension
Time frame: posoperative within 24 hrs
postoperative morbidity and infections
Time frame: posoperative within 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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 Intraperitoneal Adhesions After Rectus Muscles Approximation, run by Cairo University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 19 Jan 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 Egypt. 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 hany saad, assisstant prof (01001817211, hanysaad25280@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the intraperitoneal adhesions post rectus muscle closure (time frame: intraoperative). 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 19 Jan 2022.