Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Laparoscopic Surgery

Study Overview
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Brief Summary
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To compare robot assisted versus conventional laparoscopic surgery performed for bening gynecologic disorders regarding cosmesis, patient satisfaction and quality of life

Detailed Description
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30 patients undergoing robot assisted laparoscopic surgery for bening gynecologic disorders and 30 patients undergoing conventional laparoscopic surgery for bening gynecologic disorders will be included in the study. All surgeries will be performed in the same hospital by the same surgeon. 6 months after the surgery the patients will be called and will be informed about the trial. After confirming that the questionnaires can be sent to them by e-mail, 4 questionnaires will be sent to the patients via e-mail. To evaluate cosmesis, patient satisfaction and quality of life VAS (visual analogue scale), SF-12 (short form-12) health survey, BIQ (body image questionnaire) and POSAS (the patient and observer scar assessment scale) will be sent to the patients 6 months after the surgery. Patients who have not completed the questionnaires will be called for reminders after 1 week. Patients will be expected to complete the questionnaire completely and accurately.

Official Title
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Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Robot Assisted Versus Conventional Laparoscopic Surgery for Bening Gynecologic Disorders: a Prospective Trial

Conditions
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Gynecologic Disease, Cosmesis, Patient Satisfaction, Quality of Life

Intervention / Treatment
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* Procedure: Laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of being gynecologic disorders Patients undergoing conventional laparoscopic surgery Patients undergoing robot assisted laparoscopic surgery Patients undergoing surgery in our hospital by the same surgeon Patients willing to participate in the study Exclusion Criteria: Malignancy Requirement of emergency procedure Pregnancy Visible previous abdominal scars or keloid Inability of patient to tolerate Trendelenburg position or pneumoperitoneum Patients undergoing surgery by another surgeon or in an another hospital Mental impairment that would preclude giving informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robot assisted laparoscopic surgery<br>This group will be consisted of patients that will undergo robot assisted laparoscopic surgery for benign gynecologic disorders | Procedure: Laparoscopic surgery<br>* Patients that will undergo robot assisted laparoscopic surgery and conventional laparoscopic surgery for benign gynecologic disorders will answer 4 questionnaires to assess patient satisfaction, quality of life and cosmesis<br>|
| Conventional laparoscopic surgery<br>This group will be consisted of patients that will undergo conventional laparoscopic surgery for benign gynecologic disorders | Procedure: Laparoscopic surgery<br>* Patients that will undergo robot assisted laparoscopic surgery and conventional laparoscopic surgery for benign gynecologic disorders will answer 4 questionnaires to assess patient satisfaction, quality of life and cosmesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-perceived cosmesis | The primary outcome is to evaluate patient's satisfaction about their laparoscopic incision scars 6 months after the surgery. 6 months after the surgery the patients will be called and will be informed about the trial. After confirming that the questionnaires can be sent to them by e-mail, questionnaires will be sent to the patients. BIQ (body image questionnaire) multiple choice questionnaire to evaluate their scar will be sent to the patients 6 months after the surgery. Patients who have not completed the questionnaires will be called for reminders after 1 week. Patients will be expected to complete the questionnaires completely and accurately. | 6 months after the surgery | 
| Patient and observer scar assessment | The primary outcome is to evaluate patient's satisfaction about their laparoscopic incision scars 6 months after the surgery. 6 months after the surgery the patients will be called and will be informed about our trial. After confirming that the questionnaires can be sent to them by e-mail, questionnaires will be sent to the patients. POSAS (the patient and observer scar assessment scale) multiple choice questionnaires to evaluate their scar will be sent to the patients 6 months after the surgery. Patients who have not completed the questionnaires will be called for reminders after 1 week. Patients will be expected to complete the questionnaires completely and accurately. | 6 months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | To compare patient-reported satisfaction using a scale called visual analogue scale (VAS) will be send to the patients via e-mail. This is a 100-mm long scale with adjectival descriptions at both end positions. There will be a statement explaining what was intended to measure. Participants will be asked to mark the VAS 6 months after the surgery. On this scale 0 representing the worst and 10 the best expected appearance of their scars. | 6 months after the surgery | 
| Quality of life after robot assisted versus conventional laparoscopic surgery | Quality of life will be measured using SF-12 (short form 12) health questionnaire. This is a 12-Item Short-form Health Survey. 6 months after the surgery the patients will be called and will be informed about our trial. After confirming that the questionnaire can be sent to them by e-mail, questionnaire will be sent to the patients. Patients who have not completed the questionnaires will be called for reminders after 1 week. Patients will be expected to complete the questionnaires completely and accurately. | 6 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmesis, Laparoscopic surgery, Patient satisfaction, Scar assessment, Quality of life