Trial Outcomes & Findings for Scalpel vs Diathermy in Repeat Cesarean Delivery (NCT NCT02493608)
NCT ID: NCT02493608
Last Updated: 2020-03-24
Results Overview
Time to make an abdominal wall incision from skin to rectus fascia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
during surgery
Results posted on
2020-03-24
Participant Flow
4 were excluded from due to prior midline vertical skin incision.
Participant milestones
| Measure |
Scalpel Group
Scalpel is the device used to make abdominal wall incision in this group of patient.
scalpel: used to cut the abdominal wall.
|
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
|
|---|---|---|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Scalpel Group
n=48 Participants
Scalpel is the device used to make abdominal wall incision in this group of patient.
scalpel: used to cut the abdominal wall.
|
Diathermy Group
n=48 Participants
In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.
Diathermy: Diathermy used to cut , coagulate the tissue
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 5.1 • n=48 Participants
|
28.4 years
STANDARD_DEVIATION 5.3 • n=48 Participants
|
NA years
STANDARD_DEVIATION NA • n=96 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=48 Participants
|
48 Participants
n=48 Participants
|
96 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=48 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Gravida
|
3.1 Pregnancies
STANDARD_DEVIATION 1.1 • n=48 Participants
|
3.5 Pregnancies
STANDARD_DEVIATION 1.7 • n=48 Participants
|
NA Pregnancies
STANDARD_DEVIATION NA • n=96 Participants
|
|
Para
|
1.7 births
STANDARD_DEVIATION 0.8 • n=48 Participants
|
1.7 births
STANDARD_DEVIATION 0.8 • n=48 Participants
|
NA births
STANDARD_DEVIATION NA • n=96 Participants
|
|
Weeks of Gestation
|
38.7 Weeks
STANDARD_DEVIATION 0.7 • n=48 Participants
|
38.4 Weeks
STANDARD_DEVIATION 1.9 • n=48 Participants
|
NA Weeks
STANDARD_DEVIATION NA • n=96 Participants
|
|
Height
|
161.5 Centimeters
STANDARD_DEVIATION 7.5 • n=48 Participants
|
160 Centimeters
STANDARD_DEVIATION 7.4 • n=48 Participants
|
NA Centimeters
STANDARD_DEVIATION NA • n=96 Participants
|
|
Weight
|
85.3 kg
STANDARD_DEVIATION 17.9 • n=48 Participants
|
86.9 kg
STANDARD_DEVIATION 15.1 • n=48 Participants
|
NA kg
STANDARD_DEVIATION NA • n=96 Participants
|
|
BMI
|
32.7 kg/m^2
STANDARD_DEVIATION 6.4 • n=48 Participants
|
34.1 kg/m^2
STANDARD_DEVIATION 5.7 • n=48 Participants
|
NA kg/m^2
STANDARD_DEVIATION NA • n=96 Participants
|
|
Number of C-Sections
|
1.5 number of C-sections
STANDARD_DEVIATION 0.7 • n=48 Participants
|
1.7 number of C-sections
STANDARD_DEVIATION 0.7 • n=48 Participants
|
NA number of C-sections
STANDARD_DEVIATION NA • n=96 Participants
|
|
Type of Anesthesia
Spinal
|
44 Participants
n=48 Participants
|
46 Participants
n=48 Participants
|
90 Participants
n=96 Participants
|
|
Type of Anesthesia
Epidural
|
4 Participants
n=48 Participants
|
2 Participants
n=48 Participants
|
6 Participants
n=96 Participants
|
|
Type of Surgery
Elective
|
41 Participants
n=48 Participants
|
38 Participants
n=48 Participants
|
79 Participants
n=96 Participants
|
|
Type of Surgery
Non-Elective
|
7 Participants
n=48 Participants
|
10 Participants
n=48 Participants
|
17 Participants
n=96 Participants
|
PRIMARY outcome
Timeframe: during surgeryTime to make an abdominal wall incision from skin to rectus fascia.
Outcome measures
| Measure |
Scalpel Group
n=48 Participants
Scalpel is the device used to make abdominal wall incision in this group of patient.
scalpel: used to cut the abdominal wall.
|
Diathermy Group
n=48 Participants
In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.
Diathermy: Diathermy used to cut , coagulate the tissue
|
|---|---|---|
|
Incision Time .
|
271.5 Seconds
Standard Deviation 109.31
|
188.17 Seconds
Standard Deviation 120.03
|
SECONDARY outcome
Timeframe: Post Operative Day (POD) 1 and Day 2Done by VAS scale. Visual Analog Scale to measure pain. Scale range from 0 to 10 with higher values indicating worse pain.
Outcome measures
| Measure |
Scalpel Group
n=48 Participants
Scalpel is the device used to make abdominal wall incision in this group of patient.
scalpel: used to cut the abdominal wall.
|
Diathermy Group
n=48 Participants
In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.
Diathermy: Diathermy used to cut , coagulate the tissue
|
|---|---|---|
|
Post Operative Pain
POD 1
|
1.9 units on a scale
Standard Deviation 2.6
|
2.6 units on a scale
Standard Deviation 3.1
|
|
Post Operative Pain
POD 2
|
3.2 units on a scale
Standard Deviation 3.3
|
2.9 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Blood lost during incision/surgeryBlood lost during incision/surgery
Outcome measures
| Measure |
Scalpel Group
n=48 Participants
Scalpel is the device used to make abdominal wall incision in this group of patient.
scalpel: used to cut the abdominal wall.
|
Diathermy Group
n=48 Participants
In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.
Diathermy: Diathermy used to cut , coagulate the tissue
|
|---|---|---|
|
Blood Loss
|
15.98 grams
Standard Deviation 14.4
|
11.11 grams
Standard Deviation 15.43
|
Adverse Events
Scalpel Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diathermy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place