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

Completed

• Conditions: Cosmesis; Patient Satisfaction; Gynecologic Disease; Quality of Life
• Interventions: Procedure: Laparoscopic surgery

• Registration Number: NCT04064216
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study Start: 2019-07-16
• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robot assisted laparoscopic surgery	Laparoscopic surgery	This group will be consisted of patients that will undergo robot assisted laparoscopic surgery for benign gynecologic disorders
Conventional laparoscopic surgery	Laparoscopic surgery	This group will be consisted of patients that will undergo conventional laparoscopic surgery for benign gynecologic disorders

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Acibadem Maslak Hospital; 🇹🇷 Istanbul, Sariyer, Turkey