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

Sponsor
Acibadem University (Other)
Overall Status
Completed
CT.gov ID
NCT04064216
Collaborator
(none)
60
1
8
7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic surgery

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Jul 16, 2019
Actual Primary Completion Date :
Mar 16, 2020
Actual Study Completion Date :
Mar 16, 2020

Arms and Interventions

Arm Intervention/Treatment
Robot assisted laparoscopic surgery

This group will be consisted of patients that will undergo robot assisted laparoscopic surgery for benign gynecologic disorders

Procedure: Laparoscopic 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

Conventional laparoscopic surgery

This group will be consisted of patients that will undergo conventional laparoscopic surgery for benign gynecologic disorders

Procedure: Laparoscopic 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acibadem Maslak Hospital Istanbul Sariyer Turkey 34457

Sponsors and Collaborators

  • Acibadem University

Investigators

  • Study Director: Mete Gungor, MD,Prof., Acıbadem Mehmet Ali Aydınlar University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Esra Ozbasli, Ass. Prof., Acibadem University
ClinicalTrials.gov Identifier:
NCT04064216
Other Study ID Numbers:
  • ATADEK-2018/8
First Posted:
Aug 21, 2019
Last Update Posted:
Apr 13, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Esra Ozbasli, Ass. Prof., Acibadem University

Study Results

No Results Posted as of Apr 13, 2020