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

A

Acibadem University

Status

Completed

Conditions

Cosmesis
Quality of Life
Patient Satisfaction
Gynecologic Disease

Treatments

Procedure: Laparoscopic surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04064216
ATADEK-2018/8

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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