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The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in pregnant patients undergoing repeat elective cesarean delivery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scalpel group | Active Comparator | Scalpel is the device used to make abdominal wall incision in this group of patient. |
|
| Diathermy group | Active Comparator | In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scalpel | Device | used to cut the abdominal wall. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incision Time . | Time to make an abdominal wall incision from skin to rectus fascia. | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post Operative Day (POD) 1 and Day 2 |
| Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Caliendo, M.D | Texas Tech University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Hospital | Odessa | Texas | 79763 | United States |
4 were excluded from due to prior midline vertical skin incision.
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| ID | Title | Description |
|---|---|---|
| FG000 | Scalpel Group | Scalpel is the device used to make abdominal wall incision in this group of patient. scalpel: used to cut the abdominal wall. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Scalpel Group | Scalpel is the device used to make abdominal wall incision in this group of patient. scalpel: used to cut the abdominal wall. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incision Time . | Time to make an abdominal wall incision from skin to rectus fascia. | Posted | Mean | Standard Deviation | Seconds | during surgery |
|
From surgery to discharge an average of two days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scalpel Group | Scalpel is the device used to make abdominal wall incision in this group of patient. scalpel: used to cut the abdominal wall. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chadley Copeland | Texas Tech Health Sciences Center | 8067434752 | chadley.copeland@ttuhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2015 | Feb 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D001751 | Blade Implantation |
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D003758 | Dental Implantation, Endosseous |
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| Diathermy | Device | Diathermy used to cut , coagulate the tissue |
|
|
Blood lost during incision/surgery
| Blood lost during incision/surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Gravida | Mean | Standard Deviation | Pregnancies |
|
| Para | Mean | Standard Deviation | births |
|
| Weeks of Gestation | Mean | Standard Deviation | Weeks |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Number of C-Sections | Mean | Standard Deviation | number of C-sections |
|
| Type of Anesthesia | Count of Participants | Participants |
|
| Type of Surgery | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Post Operative Day (POD) 1 and Day 2 |
|
|
|
|
| Secondary | Blood Loss | Blood lost during incision/surgery | Posted | Mean | Standard Deviation | grams | Blood lost during incision/surgery |
|
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 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 | 0 | 48 | 0 | 48 | 0 | 48 |
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| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |
| D006979 | Hyperthermia, Induced |
POD 2
| Other |