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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064216
• Other study ID #: ATADEK-2018/8
• Status: Completed
• Start date: July 16, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: April 2020
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cosmesis
• Genital Diseases, Female
• Gynecologic Disease
• Patient Satisfaction
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Istanbul	Sariyer

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Corrado G, Calagna G, Cutillo G, Insinga S, Mancini E, Baiocco E, Zampa A, Bufalo A, Perino A, Vizza E. The Patient and Observer Scar Assessment Scale to Evaluate the Cosmetic Outcomes of the Robotic Single-Site Hysterectomy in Endometrial Cancer. Int J Gynecol Cancer. 2018 Jan;28(1):194-199. doi: 10.1097/IGC.0000000000001130. — View Citation

Korolija D, Sauerland S, Wood-Dauphinée S, Abbou CC, Eypasch E, Caballero MG, Lumsden MA, Millat B, Monson JR, Nilsson G, Pointner R, Schwenk W, Shamiyeh A, Szold A, Targarona E, Ure B, Neugebauer E; European Association for Endoscopic Surgery. Evaluation of quality of life after laparoscopic surgery: evidence-based guidelines of the European Association for Endoscopic Surgery. Surg Endosc. 2004 Jun;18(6):879-97. Epub 2004 Apr 27. Review. — View Citation

Van Loey NE, Van Son MJ. Psychopathology and psychological problems in patients with burn scars: epidemiology and management. Am J Clin Dermatol. 2003;4(4):245-72. Review. — View Citation

Yeung PP Jr, Bolden CR, Westreich D, Sobolewski C. Patient preferences of cosmesis for abdominal incisions in gynecologic surgery. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):79-84. doi: 10.1016/j.jmig.2012.09.008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after the surgery
Primary	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.	6 months after the surgery
Secondary	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.	6 months after the surgery
Secondary	Quality of life after robot assisted versus conventional laparoscopic 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.	6 months after the surgery