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

Acibadem University60 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gynecologic Disease Cosmesis Patient Satisfaction Quality of Life

Interventions

Laparoscopic surgeryPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Acibadem Maslak Hospital

Istanbul, Sariyer, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months after the surgery

Secondary Outcomes

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.

Time frame: 6 months after the surgery

Quality of life after robot assisted versus conventional laparoscopic surgery

Data from ClinicalTrials.gov

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