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Best Incision in Cesarean Section of Obese Women

Primary Purpose

Morbid Obesity, Cesarean Section Complications

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pfannenstiel incision
Supra-umbilical transverse incision
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring elective cesarean section, morbid obesity, Pfannenstiel incision, Transverse supra-umbilical incision

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Immune-compromised conditions. Premature rupture of membranes. Pre-existing skin conditions affecting the abdomen. Inability to provide informed consent.

Sites / Locations

  • Al-Hussein University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pfannenstiel incision

Supra-Umbilical

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Hospital length of stay
Hospital length of stay will be defined as the number of days from surgery until discharge from the hospital.
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.
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.

Full Information

First Posted
September 4, 2023
Last Updated
September 9, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT06032637
Brief Title
Best Incision in Cesarean Section of Obese Women
Official Title
Difference Between Pfannenstiel Incision and Higher Transverse Supra Umbilical Incision, During Elective Cesarean Section in Morbidly Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Cesarean Section Complications
Keywords
elective cesarean section, morbid obesity, Pfannenstiel incision, Transverse supra-umbilical incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pfannenstiel incision
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Supra-Umbilical
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pfannenstiel incision
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Supra-umbilical transverse incision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of surgical site wound infection
Description
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.
Time Frame
4 weeks after the surgery.
Secondary Outcome Measure Information:
Title
Operative time
Description
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.
Time Frame
during the surgery
Title
Hospital length of stay
Description
Hospital length of stay will be defined as the number of days from surgery until discharge from the hospital.
Time Frame
From day of surgery to discharge, up to 8 weeks.
Title
Estimated blood loss
Description
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.
Time Frame
during the procedure
Title
Postoperative pain
Description
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.
Time Frame
From end of surgery through 4 weeks postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study will enroll only female participants, as the surgical procedures being compared are specific to cesarean delivery. Only pregnant patients who are scheduled to undergo elective cesarean section will be included. This study is restricted to women only given the gender-specific nature of pregnancy and childbirth. Patients must be female sex at birth with intact uteri in order to be eligible. Transgender male patients and individuals with no female reproductive organs will be excluded. Enrollment is limited to cisgender women only.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Immune-compromised conditions. Premature rupture of membranes. Pre-existing skin conditions affecting the abdomen. Inability to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhamed Alhagrasy, M.D.
Phone
01017313413
Email
MuhamedAhmed.216@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhamed A Alhagrasy, M.D.
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Hussein University Hospital
City
Cairo
ZIP/Postal Code
11633
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhamed A Alhagrasy, M.D.
Phone
00201017313413
Email
MuhamedAhmed.216@azhar.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

Best Incision in Cesarean Section of Obese Women

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