Complications; Cesarean Section
Conditions
Brief summary
The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in pregnant patients undergoing repeat elective cesarean delivery.
Detailed description
It is hypothesized that wall incisions made by diathermy compared to scalpel during repeat cesarean delivery will have less incision time, as well as less blood loss. A second hypothesis is that the use of diathermy, compared with scalpel will not increase in post-operative pain. 1. This is a randomized prospective study in women undergoing elective repeat cesarean delivery at Medical Center Hospital in Odessa Texas. 2. Women undergoing cesarean delivery will be randomized into two groups: One group will undergo diathermy to incise the entire abdominal wall ,which includes skin, subcutaneous tissue, rectus muscle until the peritoneal cavity is visible. On the other group scalpel will be used to achieve the same aim. 3. A standardized abdominal wall incision will be made with either diathermy in cut mode or scalpel. Diathermy will be set in a cut mode with standard setting as per surgeons preference. All patients in the study will get standard skin incision in terms of length and depth which will be marked by a ruler. 4. Incision time ( measured in minutes and seconds with stop watch) and amount of bleeding will be measured. Blood loss will be calculated by weighing (in grams) the used lap sponges and comparing this to the weight (in grams0 of fresh lap sponges. 5. Post-operative pain will be measured by a Visual Analogue Scale (VAS). Measurements will be taken at 6:00 to 7:00 AM from post -op day 1 until hospital discharge.
Interventions
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Multiparous pregnant women 18 - 45 years. * Gestational ages 37 weeks to 41 weeks, * Undergoing repeat elective or repeat emergency cesarean deliveries.
Exclusion criteria
* Informed consent can't be obtained in a manner that allows for no impression of undue influence/pressure or sufficient time for patient to consider participation. * Primary Cesarean deliveries - as these can bias the selection. * Skin conditions such as infections, psoriasis, and eczema.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incision Time . | during surgery | Time to make an abdominal wall incision from skin to rectus fascia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain | Post Operative Day (POD) 1 and Day 2 | Done by VAS scale. Visual Analog Scale to measure pain. Scale range from 0 to 10 with higher values indicating worse pain. |
| Blood Loss | Blood lost during incision/surgery | Blood lost during incision/surgery |
Countries
United States
Participant flow
Pre-assignment details
4 were excluded from due to prior midline vertical skin incision.
Participants by arm
| Arm | Count |
|---|---|
| Scalpel Group Scalpel is the device used to make abdominal wall incision in this group of patient.
scalpel: used to cut the abdominal wall. | 48 |
| Diathermy Group In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.
Diathermy: Diathermy used to cut , coagulate the tissue | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | Scalpel Group | Diathermy Group | Total |
|---|---|---|---|
| Age, Continuous | 26.9 years STANDARD_DEVIATION 5.1 | 28.4 years STANDARD_DEVIATION 5.3 | NA years |
| BMI | 32.7 kg/m^2 STANDARD_DEVIATION 6.4 | 34.1 kg/m^2 STANDARD_DEVIATION 5.7 | NA kg/m^2 |
| Gravida | 3.1 Pregnancies STANDARD_DEVIATION 1.1 | 3.5 Pregnancies STANDARD_DEVIATION 1.7 | NA Pregnancies |
| Height | 161.5 Centimeters STANDARD_DEVIATION 7.5 | 160 Centimeters STANDARD_DEVIATION 7.4 | NA Centimeters |
| Number of C-Sections | 1.5 number of C-sections STANDARD_DEVIATION 0.7 | 1.7 number of C-sections STANDARD_DEVIATION 0.7 | NA number of C-sections |
| Para | 1.7 births STANDARD_DEVIATION 0.8 | 1.7 births STANDARD_DEVIATION 0.8 | NA births |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 48 Participants | 48 Participants | 96 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of Anesthesia Epidural | 4 Participants | 2 Participants | 6 Participants |
| Type of Anesthesia Spinal | 44 Participants | 46 Participants | 90 Participants |
| Type of Surgery Elective | 41 Participants | 38 Participants | 79 Participants |
| Type of Surgery Non-Elective | 7 Participants | 10 Participants | 17 Participants |
| Weeks of Gestation | 38.7 Weeks STANDARD_DEVIATION 0.7 | 38.4 Weeks STANDARD_DEVIATION 1.9 | NA Weeks |
| Weight | 85.3 kg STANDARD_DEVIATION 17.9 | 86.9 kg STANDARD_DEVIATION 15.1 | NA kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Incision Time .
Time to make an abdominal wall incision from skin to rectus fascia.
Time frame: during surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scalpel Group | Incision Time . | 271.5 Seconds | Standard Deviation 109.31 |
| Diathermy Group | Incision Time . | 188.17 Seconds | Standard Deviation 120.03 |
p-value: <0.001t-test, 2 sided
Secondary
Blood Loss
Blood lost during incision/surgery
Time frame: Blood lost during incision/surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scalpel Group | Blood Loss | 15.98 grams | Standard Deviation 14.4 |
| Diathermy Group | Blood Loss | 11.11 grams | Standard Deviation 15.43 |
p-value: 0.113t-test, 2 sided
Secondary
Post Operative Pain
Done by VAS scale. Visual Analog Scale to measure pain. Scale range from 0 to 10 with higher values indicating worse pain.
Time frame: Post Operative Day (POD) 1 and Day 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scalpel Group | Post Operative Pain | POD 1 | 1.9 units on a scale | Standard Deviation 2.6 |
| Scalpel Group | Post Operative Pain | POD 2 | 3.2 units on a scale | Standard Deviation 3.3 |
| Diathermy Group | Post Operative Pain | POD 1 | 2.6 units on a scale | Standard Deviation 3.1 |
| Diathermy Group | Post Operative Pain | POD 2 | 2.9 units on a scale | Standard Deviation 3.2 |
p-value: 0.218t-test, 2 sided
p-value: 0.638t-test, 2 sided