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Clinical Trials/NCT04064216
NCT04064216
Completed
Not Applicable

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

Acibadem University1 site in 1 country60 target enrollmentJuly 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gynecologic Disease
Sponsor
Acibadem University
Enrollment
60
Locations
1
Primary Endpoint
Patient-perceived cosmesis
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 16, 2019
End Date
March 16, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Acibadem University
Responsible Party
Principal Investigator
Principal Investigator

Esra Ozbasli

Ass. Prof.

Acibadem University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient-perceived cosmesis

Time Frame: 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

Time Frame: 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 Outcomes

  • Patient satisfaction(6 months after the surgery)
  • Quality of life after robot assisted versus conventional laparoscopic surgery(6 months after the surgery)

Study Sites (1)

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