Robotic Versus Laparoscopic Surgery for Deep Endometriosis

NCT ID: NCT05179109

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Endometriosis Deep Endometriosis Surgery

Keywords

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Endometriosis surgery Deep endometriosis surgery Robotic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robot-assisted laparoscopy

Surgery for deep endometriosis using robot-assisted laparoscopy.

Group Type EXPERIMENTAL

Minimally invasive surgery

Intervention Type PROCEDURE

Minimally invasive surgery for severe deep endometriosis

Conventional laparoscopy

Surgery for deep endometriosis using conventional laparoscopy.

Group Type ACTIVE_COMPARATOR

Minimally invasive surgery

Intervention Type PROCEDURE

Minimally invasive surgery for severe deep endometriosis

Interventions

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Minimally invasive surgery

Minimally invasive surgery for severe deep endometriosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Sari Koivurova

Assistant Chief of Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sari Koivurova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital, Department of Obstetrics and Gynecology

Locations

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Northern Ostrobothnia Hospital District

Oulu, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Anna M Terho, MD

Role: CONTACT

Phone: +35883153603

Email: [email protected]

Sari Koivurova, MD, PhD

Role: CONTACT

Phone: +35883153082

Email: [email protected]

Facility Contacts

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Koivurova

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35851028 (View on PubMed)

Other Identifiers

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ROBtrial1

Identifier Type: -

Identifier Source: org_study_id