Cesarean Section ComplicationsNCT04156282
Knot Burial Technique for Rectus Sheath Closure
A study testing knot burial technique and classical closure in people with Cesarean Section Complications, run by Ain Shams University at 1 site in Egypt.
Trial summary
Caesarean section is one of the most commonly performed abdominal operations on women in most countries of the world. Its rate has increased markedly in recent years, and is about 20-25% of all child-births in most developed countries. The present study was a step to reduce postoperative pain in cesarean sections. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- knot burial technique and classical closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteEgypt
- Study dates
- 9 May 2019to 14 Oct 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Term pregnancy ( more than 37 weeks of gestation ) candidate for transverse incision elective cesarean delivery
Who cannot join
- patient with BMI >30 and fat thickness >3 cm.
- patient with haemoglobin less than 10g/dL
- patient with previous history of septic wound.
- Emergency lower segment cesarean section.
- Patients complaining of premature rupture of membrane.
- Patients need intra abdominal drains post cesarean sections
- Patients with established or gestational diabetes, coagulation defects, hemodynamic instability, septicemia or chorioamnionitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knot Burial Technique for Rectus Sheath Closure in Relation to Post Operative Pain in Elective Cesarean Section
Caesarean section is one of the most commonly performed abdominal operations on women in most countries of the world. Its rate has increased markedly in recent years, and is about 20-25% of all child-births in most developed countries.
The present study was a step to reduce postoperative pain in cesarean sections. Because of the large number of women that undergo caesarean section, even small differences in post-operative morbidity rates due to different techniques could translate into improved health and significant savings of cost and health services resources.
Read more
Closing the rectus sheath in cesarean sections with the knots pricking through the skin causes significant postoperative pain, discomfort and delayed ambulation. No comments in literature regarding the best way for closing the rectus sheath in cesarean sections.
AIM/ OBJECTIVES The aim of this study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean section in reducing post operative pain and discomfort.
Study hypothesis:
In women undergoing cesarean sections may or may not burying knots beneath the rectus sheath reduce the post operative pain and discomfort.
Read the detailed description
Non absorbable and delayed absorbable monofilament materials require meticulous care to prevent knot slippage.
One common problem that arises from use of these materials is the discomfort caused by the knot pricking through the skin. Although this is a common problem after cesarean section, it is often overlooked and only very few preventive techniques have been described.
This study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean sections in reducing post operative pain and discomfort.
Type of Study : A randomized controlled clinical trial. Study Setting :this study will be conducted at the department of Obstetrics and Gynecology at Ain-Shams University Maternity hospital.
Study time: 2019. Study Population : The study population comprises pregnant women, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, during the study period, who are planned for cesarean delivery.
- Conditions
- Cesarean Section Complications
- Being tested
- knot burial technique, classical closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knot burial techniqueProcedure or surgery
surgical suturing intervention
classical closureProcedure or surgery
surgical suturing intervention
| Study group | Role | What they receive |
|---|---|---|
| classical closure. | Active comparator | In this group, the rectus sheath closure will be done by simple running continuous sutures with the knots beneath the subcutaneous layer. Receives: Procedure: classical closure |
| knot burial technique | Active comparator | The surgeon holds the left angle of the rectus sheath incision with an Allis. Using (Polyglactin 910) suture,The needle is taken from the inside outward on the upper edge.The needle is then taken lateral to the Allis and brought back into the wound by taking it through the inferior edge from outside to inside . A square knot is tied with three or four throws. The needle is then taken out of the wound through the upper edge and continuous running stitches . As the right angle is approached, the angle is held with an Allis. the suture, will be taken through the lower edge, is brought outside the wound and passed between the blades of a closed Allis before taking it inside out on the upper edge. One more bite is taken but this time just lateral to the Allis holding the angle, and the needle is brought back into the wound and to the outside between the edges of the rectus sheath. Using the loop of polyglactin held with the Allis , an Aberdeen knot is tied after removing the Allis. Receives: Procedure: knot burial technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing the post operative pain and discomfort
by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.
Measured: the first twenty-four hours after delivery.
changing the post operative pain and discomfort
by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.
Measured: one week after delivery
changing the post operative pain and discomfort
by Visual Analogue pain Scale from ,(0) which means no pain to ( 10) means sever pain.
Measured: two weeks after delivery.
Secondary outcomes (3)
wound assessment for suture granuloma formation
by scar tissue palpation for ( presence ) or (absence) of a forming mass.
Measured: one week post operative
early ambulation after cesarean section
by observation and history taking , early ambulation within two hours post operative (yes) or (no)
Measured: two hours after delivery
early breast feeding after cesarean section
by observation and history taking, early breast feeding within two hours post operative (yes) or (no)
Measured: two hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start9 May 2019
- Primary completion9 Oct 2019
- Study completion14 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- we will analyze 400 candidate for elective cesarean sections, divided into two groups ,each of 200 patients according to the rectus sheath closure:
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Ibrahim Gaber Elsayed, Ain Shams University
- Investigators
- Nashwa elsaid, prof.Dr, Study director, AinShams UniversityReda Mokhtar, Lecture, Study director, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156282
- Sponsor's protocol ID
- FWA 0000175858
- Status last verified
- Nov 2019
- First submitted
- 14 Oct 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knot Burial Technique for Rectus Sheath Closure in Relation to Post Operative Pain in Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT04156282
- Acronym / sponsor ID
- FWA 0000175858
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 7 Nov 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.
Caesarean section is one of the most commonly performed abdominal operations on women in most countries of the world. Its rate has increased markedly in recent years, and is about 20-25% of all child-births in most developed countries.
The present study was a step to reduce postoperative pain in cesarean sections. Because of the large number of women that undergo caesarean section, even small differences in post-operative morbidity rates due to different techniques could translate into improved health and significant savings of cost and health services resources.
Closing the rectus sheath in cesarean sections with the knots pricking through the skin causes significant postoperative pain, discomfort and delayed ambulation. No comments in literature regarding the best way for closing the rectus sheath in cesarean sections.
AIM/ OBJECTIVES The aim of this study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean section in reducing post operative pain and discomfort.
Study hypothesis:
In women undergoing cesarean sections may or may not burying knots beneath the rectus sheath reduce the post operative pain and discomfort.
Detailed description
Non absorbable and delayed absorbable monofilament materials require meticulous care to prevent knot slippage.
One common problem that arises from use of these materials is the discomfort caused by the knot pricking through the skin. Although this is a common problem after cesarean section, it is often overlooked and only very few preventive techniques have been described.
This study is to assess the efficacy of burying knots beneath the rectus sheath during cesarean sections in reducing post operative pain and discomfort.
Type of Study : A randomized controlled clinical trial. Study Setting :this study will be conducted at the department of Obstetrics and Gynecology at Ain-Shams University Maternity hospital.
Study time: 2019. Study Population : The study population comprises pregnant women, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, during the study period, who are planned for cesarean delivery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- we will analyze 400 candidate for elective cesarean sections, divided into two groups ,each of 200 patients according to the rectus sheath closure:
| Arm | Type | Receives |
|---|---|---|
| classical closure. | Active comparator | Procedure: classical closureIn this group, the rectus sheath closure will be done by simple running continuous sutures with the knots beneath the subcutaneous layer. |
| knot burial technique | Active comparator | Procedure: knot burial techniqueThe surgeon holds the left angle of the rectus sheath incision with an Allis. Using (Polyglactin 910) suture,The needle is taken from the inside outward on the upper edge.The needle is then taken lateral to the Allis and brought back into the wound by taking it through the inferior edge from outside to inside . A square knot is tied with three or four throws. The needle is then taken out of the wound through the upper edge and continuous running stitches . As the right angle is approached, the angle is held with an Allis. the suture, will be taken through the lower edge, is brought outside the wound and passed between the blades of a closed Allis before taking it inside out on the upper edge. One more bite is taken but this time just lateral to the Allis holding the angle, and the needle is brought back into the wound and to the outside between the edges of the rectus sheath. Using the loop of polyglactin held with the Allis , an Aberdeen knot is tied after removing the Allis. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Term pregnancy ( more than 37 weeks of gestation ) candidate for transverse incision elective cesarean delivery
Key exclusion criteria (7 listed)
- patient with BMI >30 and fat thickness >3 cm.
- patient with haemoglobin less than 10g/dL
- patient with previous history of septic wound.
- Emergency lower segment cesarean section.
- Patients complaining of premature rupture of membrane.
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 |
|---|---|---|
| knot burial techniquesurgical suturing intervention | Procedure or surgery | knot burial technique |
| classical closuresurgical suturing intervention | Procedure or surgery | classical closure. |
Primary outcome
changing the post operative pain and discomfort
Time frame: the first twenty-four hours after delivery.
by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.
changing the post operative pain and discomfort
Time frame: one week after delivery
by Visual Analogue pain Scale (0) means no pain ,( 10) means sever pain.
changing the post operative pain and discomfort
Time frame: two weeks after delivery.
by Visual Analogue pain Scale from ,(0) which means no pain to ( 10) means sever pain.
3 secondary outcomes
wound assessment for suture granuloma formation
Time frame: one week post operative
early ambulation after cesarean section
Time frame: two hours after delivery
early breast feeding after cesarean section
Time frame: two hours after delivery
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 7 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Nashwa elsaid, prof.Dr study director
AinShams University
Reda Mokhtar, Lecture study director
AinShams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knot burial technique and classical closure in people with Cesarean Section Complications, run by Ain Shams 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 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: finished, as of the sponsor's last update on 7 Nov 2019. 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?
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?
changing the post operative pain and discomfort (time frame: the first twenty-four hours after delivery.). The study lists 3 primary outcomes in all. 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 7 Nov 2019.