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The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Route A: Traditional laparoscopy | Active Comparator |
| |
| Route B: Single site laparoscopy | Experimental |
| |
| Route C:V-Notes surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional laparoscopy | Procedure | Utilizes three or four ports for access and retrieval. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire | This questionnaire has 40 questions, score varies from 40 (poor)-200 (excellent) a higher number indicating a better outcome | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis as assessed by the Body Image Questionnaire | This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image | 2 weeks post surgery |
| Cosmesis as assessed by the Body Image Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randa J Jalloul, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Single site laparoscopy | Procedure | One port is placed via a 2 to 3 cm umbilical/fascia incision. With this technique, there is a single incision, hidden in the umbilicus. |
|
| V-Notes surgery | Procedure | One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars. |
|
This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image |
| 6 weeks post surgery |
| Cosmesis as assessed by the Body Image Questionnaire | This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image | 3 months post surgery |
| Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI) | This has 9 items that address sexual dysfunctions. Each of these items are scored on a six-point scale ranging from 0 to 5, higher the score the better sexual function. | Baseline, 3 months post surgery |
| Pain as assessed by the Resting Visual Analog Scale (VAS) | Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS) | 24 hours post surgery |
| Pain as assessed by the Resting Visual Analog Scale (VAS) | Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS) | 2 weeks post surgery |
| Pain as assessed by the Resting Visual Analog Scale (VAS) | Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS) | 6 weeks post surgery |
| Pain as assessed by the Resting Visual Analog Scale (VAS) | Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS) | 3 months post surgery |
| Pain as assessed by the Dynamic Visual Analog Scale (VAS) | Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain after a voluntary cough (dynamic VAS) | 3 months post surgery |
| Patient satisfaction as assessed by the satisfaction scale | Patients will rate their satisfaction on a 5 point Likert scale from 1(very unsatisfied) to 5(very satisfied) | 3 months post surgery |
| D000091662 | Genital Diseases |
| D007246 | Infertility |