Robotic Versus Laparoscopic Surgery for Deep Endometriosis

NCT05179109 | Recruiting

• 1 other identifier: ROBtrial1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometriosis; Deep Endometriosis; Surgery

Keywords

Endometriosis surgery; Deep endometriosis surgery; Robotic surgery

Outcome Measures

Primary Outcomes (1)

• NRS (Numeric rating scale) Score for pain

  The surgical outcome as regards to pain symptoms (NRS questionnaire), absolute scores and change from baseline for both study groups.

  Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively

Secondary Outcomes (7)

• Intraoperative measures

  Up to 300 minutes (intraoperative)

• Factors concerning ERAS (Enhanced recovery after surgery)

  Up to 7 days (Hospital stay)

• Cost

  Primary hospital stay and 24 months, for both study groups.

• Complications

  30 days

• Endometriosis-related quality-of-life

  6, 12 and 24 months

Study Arms (2)

Robot-assisted laparoscopy

EXPERIMENTAL

Surgery for deep endometriosis using robot-assisted laparoscopy.

Procedure: Minimally invasive surgery

Conventional laparoscopy

ACTIVE COMPARATOR

Surgery for deep endometriosis using conventional laparoscopy.

Procedure: Minimally invasive surgery

Interventions

Minimally invasive surgery PROCEDURE

Minimally invasive surgery for severe deep endometriosis

Conventional laparoscopy; Robot-assisted laparoscopy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• ASA \> 3
• Recurring rectosigmoid endometriosis

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Northern Ostrobothnia Hospital District

Oulu, 90220, Finland

RECRUITING

Related Publications (1)

• Terho AM, Makela-Kaikkonen J, Ohtonen P, Uimari O, Puhto T, Rautio T, Koivurova S. Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial). BMJ Open. 2022 Jul 18;12(7):e063572. doi: 10.1136/bmjopen-2022-063572.

  PMID: 35851028 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Sari Koivurova, MD, PhD

  Oulu University Hospital, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna M Terho, MD

CONTACT

+35883153603; anna.terho@fimnet.fi

Sari Koivurova, MD, PhD

CONTACT

+35883153082; sari.koivurova@fimnet.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Chief of Gynecology

Model Details: This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 5, 2022
• Study Start: October 3, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

FI (1)