Robotic Versus Laparoscopic Surgery for Deep Endometriosis (ROBEndo)

University of Oulu

Status: Enrolling

Conditions: Surgery; Deep Endometriosis; Endometriosis

Treatments: Procedure: Minimally invasive surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05179109

ROBtrial1

Details and patient eligibility

About

The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.

Full description

The objective of this prospective, randomized trial is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome at 6, 12 and 24 months postoperatively, measured by questionnaires concerning the pain symptoms and disease-related quality-of life.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA (American Society of Anesthesiologists physical status classification) 1-3
• Diagnosed deep endometriosis (MRI)
• Patient has symptoms
• Operative treatment is indicated
• Patient is able to give informed consent

Exclusion criteria

• ASA > 3
• Recurring rectosigmoid endometriosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Robot-assisted laparoscopy

Experimental group

Description:

Surgery for deep endometriosis using robot-assisted laparoscopy.

Treatment:

Procedure: Minimally invasive surgery

Conventional laparoscopy

Active Comparator group

Description:

Surgery for deep endometriosis using conventional laparoscopy.

Treatment:

Procedure: Minimally invasive surgery