Morbid ObesityNCT06032637
Best Incision in Cesarean Section of Obese Women
A study testing Pfannenstiel incision and Supra-umbilical transverse incision in people with Morbid Obesity and Cesarean Section Complications, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher transverse supra umbilical incision techniques during elective cesarean section in morbidly obese patients. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Morbid Obesity, Cesarean Section Complications
- What is being tested?
- Pfannenstiel incision and Supra-umbilical transverse incision
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 30 Oct 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged between 20 and 40 years.
- Singleton pregnancy.
- Gestational age ≥ 37 weeks.
- Scheduled for elective cesarean delivery.
- Morbid obesity, defined as pre-pregnancy body mass index (BMI) ≥ 40 kg/m2.
- Willing and able to provide informed consent.
- Able to adhere to study procedures and follow-up schedule.
Who cannot join
- Emergency cesarean delivery.
- Multiple gestation (twins, triplets, etc)
- Placenta previa or vasa previa.
- History of more than 1 previous cesarean delivery.
- HIV, hepatitis B/C infection.
- Current anticoagulation therapy.
Show all 10Show fewer
- Immune-compromised conditions.
- Premature rupture of membranes.
- Pre-existing skin conditions affecting the abdomen.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Difference Between Pfannenstiel Incision and Higher Transverse Supra Umbilical Incision, During Elective Cesarean Section in Morbidly Obese Patients
The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher transverse supra umbilical incision techniques during elective cesarean section in morbidly obese patients. The main questions it aims to answer are:
Is there a difference in operative time between the two incision techniques? Is there a difference in estimated blood loss between the two techniques? Is there a difference in post-operative pain scores between the two techniques? Is there a difference in wound complication rates between the two techniques? Participants will be randomly assigned to receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during their scheduled cesarean delivery.
Researchers will compare the Pfannenstiel incision group to the higher transverse supra umbilical incision group to see if there are differences in operative time, blood loss, post-operative pain, and wound complications.
Read the detailed description
This randomized controlled trial will enroll 60 morbidly obese pregnant patients scheduled for elective cesarean delivery at gestational age ≥37 weeks. Morbid obesity will be defined as pre-pregnancy body mass index ≥40 kg/m2.
Patients will be randomly allocated to one of two groups (30 patients per group):
Group 1 (Pfannenstiel group): Patients will undergo a transverse infraumbilical skin incision 2-3 cm above the symphysis pubis, followed by transverse incision of the anterior rectus sheath in the same line as the skin incision, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.
Group 2 (Supra-umbilical transverse group): Patients will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, followed by transverse incision of the anterior rectus sheath in the same line, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.
The primary outcome measures will be operative time, estimated blood loss, post-operative pain scores, and wound complication rates. Secondary outcomes will include length of hospital stay, patient satisfaction scores, and cosmetic results.
- Conditions
- Morbid Obesity, Cesarean Section Complications
- Being tested
- Pfannenstiel incision, Supra-umbilical transverse incision
- Keywords
- elective cesarean section, morbid obesity, Pfannenstiel incision, Transverse supra-umbilical incision
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfannenstiel incisionProcedure or surgery
Patients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly.
Supra-umbilical transverse incisionProcedure or surgery
Patients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision 3-4cm above the umbilicus, extending laterally to the semilunar lines, without panniculus retraction. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. The rectus sheath will be incised transversely using electrocautery for hemostasis, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually along the midline using blunt dissection. The peritoneum will be transversely incised and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly.
| Study group | Role | What they receive |
|---|---|---|
| Pfannenstiel incision | Active comparator | Patients randomized to the Pfannenstiel incision arm will undergo a transverse skin incision 2-3cm above the symphysis pubis. Subcutaneous tissue will be dissected until anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the inferior epigastric arteries. Rectus muscles will be separated manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly. Receives: Procedure: Pfannenstiel incision |
| Supra-Umbilical | Experimental | Patients randomized to the supra-umbilical transverse incision arm will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. Subcutaneous tissue will be bluntly dissected until anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. Rectus muscles will be split manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly. Receives: Procedure: Supra-umbilical transverse incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of surgical site wound infection
Surgical site infections will be assessed at the cesarean incision site and tracked for 4 weeks postoperatively. Wound infection will be defined as purulent drainage from the incision, positive culture, and/or at least two of the following signs or symptoms: pain or tenderness, localized swelling, redness, or heat. The 4-week timeframe starts on the day of surgery (day 0) and ends 28 days postoperatively. Wound infections occurring up to 4 weeks after surgery will be captured and recorded as the primary outcome measure. Wound assessments will be performed daily during the hospital stay, at the post-op visit around 2 weeks, and at the 4-week follow-up visit.
Measured: 4 weeks after the surgery.
Secondary outcomes (4)
Operative time
Operative time will be defined as the time from skin incision to complete wound closure. It will be recorded in minutes by a study investigator observing each procedure.
Measured: during the surgery
Hospital length of stay
Hospital length of stay will be defined as the number of days from surgery until discharge from the hospital.
Measured: From day of surgery to discharge, up to 8 weeks.
Estimated blood loss
Estimated blood loss will be assessed by the anesthesiologist and surgeon at the end of the procedure, based on the amount of blood in the suction canister and blood-soaked sponges/lap pads.
Measured: during the procedure
Postoperative pain
Postoperative pain will be assessed using a visual analog scale (VAS) of 0-10, with 0 being no pain and 10 being worst possible pain. Patients will rate their pain level at set intervals after surgery - immediately after recovery room discharge, daily while inpatient, and at 2 weeks and 4 weeks postop during follow-up visits.
Measured: From end of surgery through 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Aug 2022
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy, Al-Azhar University
- Investigators
- Muhamed A Alhagrasy, M.D., Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032637
- Sponsor's protocol ID
- Obstet1222
- Status last verified
- Feb 2024
- First submitted
- 4 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study involves a vulnerable population of pregnant women and collecting sensitive health information. Sharing individual participant data could risk participant privacy and confidentiality even if de-identified. The sample size is small at only 60 participants. individual participant data from such a small sample has a higher risk of re-identification. The research team intends to use the individual participant data for additional analyses and future studies. Sharing individual participant data may lead to misuse, misinterpretation, or compromised validity if not properly analyzed. Logistical barriers make preparing and curating a database for individual participant data sharing highly resource and time intensive for the research team.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference Between Pfannenstiel Incision and Higher Transverse Supra Umbilical Incision, During Elective Cesarean Section in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT06032637
- Acronym / sponsor ID
- Obstet1222
- Conditions
- Morbid Obesity, Cesarean Section Complications
- Keywords
- elective cesarean section, morbid obesity, Pfannenstiel incision, Transverse supra-umbilical incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 13 Sep 2023 (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 goal of this comparative clinical trial is to compare Pfannenstiel incision and higher transverse supra umbilical incision techniques during elective cesarean section in morbidly obese patients. The main questions it aims to answer are:
Is there a difference in operative time between the two incision techniques? Is there a difference in estimated blood loss between the two techniques? Is there a difference in post-operative pain scores between the two techniques? Is there a difference in wound complication rates between the two techniques? Participants will be randomly assigned to receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during their scheduled cesarean delivery.
Researchers will compare the Pfannenstiel incision group to the higher transverse supra umbilical incision group to see if there are differences in operative time, blood loss, post-operative pain, and wound complications.
Detailed description
This randomized controlled trial will enroll 60 morbidly obese pregnant patients scheduled for elective cesarean delivery at gestational age ≥37 weeks. Morbid obesity will be defined as pre-pregnancy body mass index ≥40 kg/m2.
Patients will be randomly allocated to one of two groups (30 patients per group):
Group 1 (Pfannenstiel group): Patients will undergo a transverse infraumbilical skin incision 2-3 cm above the symphysis pubis, followed by transverse incision of the anterior rectus sheath in the same line as the skin incision, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.
Group 2 (Supra-umbilical transverse group): Patients will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, followed by transverse incision of the anterior rectus sheath in the same line, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.
The primary outcome measures will be operative time, estimated blood loss, post-operative pain scores, and wound complication rates. Secondary outcomes will include length of hospital stay, patient satisfaction scores, and cosmetic results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pfannenstiel incision | Active comparator | Procedure: Pfannenstiel incisionPatients randomized to the Pfannenstiel incision arm will undergo a transverse skin incision 2-3cm above the symphysis pubis. Subcutaneous tissue will be dissected until anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the inferior epigastric arteries. Rectus muscles will be separated manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly. |
| Supra-Umbilical | Experimental | Procedure: Supra-umbilical transverse incisionPatients randomized to the supra-umbilical transverse incision arm will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. Subcutaneous tissue will be bluntly dissected until anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. Rectus muscles will be split manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female patients aged between 20 and 40 years.
- Singleton pregnancy.
- Gestational age ≥ 37 weeks.
- Scheduled for elective cesarean delivery.
- Morbid obesity, defined as pre-pregnancy body mass index (BMI) ≥ 40 kg/m2.
Key exclusion criteria (10 listed)
- Emergency cesarean delivery.
- Multiple gestation (twins, triplets, etc)
- Placenta previa or vasa previa.
- History of more than 1 previous cesarean delivery.
- HIV, hepatitis B/C infection.
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 |
|---|---|---|
| Pfannenstiel incisionPatients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly. | Procedure or surgery | Pfannenstiel incision |
| Supra-umbilical transverse incisionPatients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision 3-4cm above the umbilicus, extending laterally to the semilunar lines, without panniculus retraction. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. The rectus sheath will be incised transversely using electrocautery for hemostasis, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually along the midline using blunt dissection. The peritoneum will be transversely incised and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly. | Procedure or surgery | Supra-Umbilical |
Primary outcome
Rate of surgical site wound infection
Time frame: 4 weeks after the surgery.
Surgical site infections will be assessed at the cesarean incision site and tracked for 4 weeks postoperatively. Wound infection will be defined as purulent drainage from the incision, positive culture, and/or at least two of the following signs or symptoms: pain or tenderness, localized swelling, redness, or heat. The 4-week timeframe starts on the day of surgery (day 0) and ends 28 days postoperatively. Wound infections occurring up to 4 weeks after surgery will be captured and recorded as the primary outcome measure. Wound assessments will be performed daily during the hospital stay, at the post-op visit around 2 weeks, and at the 4-week follow-up visit.
4 secondary outcomes
Operative time
Time frame: during the surgery
Hospital length of stay
Time frame: From day of surgery to discharge, up to 8 weeks.
Estimated blood loss
Time frame: during the procedure
Postoperative pain
Time frame: From end of surgery through 4 weeks postoperatively
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 20 Feb 2024.
- Individual participant dataSharing planned: No. The study involves a vulnerable population of pregnant women and collecting sensitive health information. Sharing individual participant data could risk participant privacy and confidentiality even if de-identified. The sample size is small at only 60 participants. individual participant data from such a small sample has a higher risk of re-identification. The research team intends to use the individual participant data for additional analyses and future studies. Sharing individual participant data may lead to misuse, misinterpretation, or compromised validity if not properly analyzed. Logistical barriers make preparing and curating a database for individual participant data sharing highly resource and time intensive for the research team.
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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.
Muhamed A Alhagrasy, M.D. principal investigator
Al-Azhar 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 Pfannenstiel incision and Supra-umbilical transverse incision in people with Morbid Obesity and Cesarean Section Complications, run by Al-Azhar 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 7 inclusion and 10 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 20 Feb 2024. 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?
Rate of surgical site wound infection (time frame: 4 weeks after the surgery.). 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 20 Feb 2024.