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NCT Number: NCT05179109

Robotic Versus Laparoscopic Surgery for Deep Endometriosis

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

Recruiting

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Key information

Conditions

Endometriosis Deep Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Surgery Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northern Ostrobothnia Hospital District

Oulu, 90220, Finland

Location status: Recruiting

Location contact

Koivurova

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally Invasive Surgery

Procedure

Minimally invasive surgery for severe deep endometriosis

Primary outcomes

  1. NRS (Numeric rating scale) Score for pain

    Time frame: Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively

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

Secondary outcomes

  1. Intraoperative measures

    Time frame: Up to 300 minutes (intraoperative)

    Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.

  2. Factors concerning ERAS (Enhanced recovery after surgery)

    Time frame: Up to 7 days (Hospital stay)

    Nausea (yes/no), vomiting (yes/no), peroral intake (minutes from surgery), mobilization (minutes from surgery), bowel movement (minutes from surgery), time of discharge (hours after surgery), complications (classified according to Clavien-Dindo) for both study groups.

  3. Cost

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

    Cost, euros.

  4. Complications

    Time frame: 30 days

    Complications (classified according to Clavien-Dindo), readmissions to hospital.

  5. Endometriosis-related quality-of-life

    Time frame: 6, 12 and 24 months

    Quality-of-life questionnaire (EHP-30, Endometriosis-related health profile) described as absolute scores and change from the baseline. Scale 0-100. Score 0 equals the best outcome and score 100 equals the worst outcome.

  6. General 15 dimensional health-related quality-of-life questionnaire

    Time frame: 6, 12 and 24 months

    Quality-of-life questionnaire (15D, general quality-of-life questionnaire) described as absolute scores and change from baseline for both study groups. Scale 0-1. Score 0 equals the worst outcome and score 1 equals the best outcome.

  7. Sexual quality-of-life questionnaire

    Time frame: 6, 12 and 24 months

    Quality-of-life (FSFI, female sexual function index) described as absolute scores and change from baseline for both study groups. Scale 2,0-36,0. Score 2,0 equals the worst outcome and score 36,0 equals the best outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna M Terho, MD

CONTACT

[email protected]

+35883153603

Sari Koivurova, MD, PhD

CONTACT

[email protected]

+35883153082

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial

Acronym: ROBEndo

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 5, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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