Cosmesis, Gynecologic Disease, Patient Satisfaction, Quality of Life
Conditions
Keywords
Cosmesis, Laparoscopic surgery, Patient satisfaction, Scar assessment, Quality of life
Brief summary
To compare robot assisted versus conventional laparoscopic surgery performed for bening gynecologic disorders regarding cosmesis, patient satisfaction and quality of life
Detailed description
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.
Interventions
PROCEDURELaparoscopic surgery
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
Sponsors
Acibadem University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-perceived cosmesis | 6 months after the surgery | 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. |
| Patient and observer scar assessment | 6 months after the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 6 months after the surgery | 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. |
| Quality of life after robot assisted versus conventional laparoscopic surgery | 6 months after the 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed