Skip to content

Effect of preoperative Enzian scoring and digital rectal examination on operative predictability and surgical outcomes in women with endometriosis: a randomized multicenter trial

Effect of preoperative Enzian scoring and digital rectal examination on operative predictability and surgical outcomes in women with endometriosis: a randomized multicenter trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040760
Enrollment
360
Registered
2026-07-02
Start date
2024-04-21
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N80.9

Interventions

Group 1: The study was conducted as a prospective, randomized, three-arm multicenter trial at three certified endometriosis centers in Germany. Women aged 18 years or older with suspected symptomatic

Sponsors

Städtisches Klinikum Karlsruhe
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - The patients are suspected of having symptomatic endometriosis. - By signing the informed consent form, the patients agreed that their data may be used for the purposes of the study.

Exclusion criteria

Exclusion criteria: Patients cannot be included if any of the above-mentioned criteria are not met. In particular, participation in the study is not possible for patients who lack the capacity to provide informed consent.

Design outcomes

Primary

MeasureTime frame
The primary outcome was operative predictability, defined as the absolute difference between the estimated and actual operating times. Secondary outcomes included perioperative safety and surgical outcomes, agreement between preoperative and intraoperative #Enzian findings, postoperative pain, and patient satisfaction. All data were collected prospectively in pseudonymized form using a standardized case report form and were analyzed according to the intention-to-treat principle. Six to twelve weeks postoperatively, participants were contacted by telephone by the study team and subsequently completed a follow-up questionnaire evaluating pain outcomes and patient satisfaction.

Secondary

MeasureTime frame
The secondary endpoints included perioperative safety and surgical outcomes, concordance between preoperative and intraoperative #Enzian findings, postoperative pain outcomes, and patient satisfaction assessed 6–12 weeks after surgery.

Countries

Germany

Contacts

Public ContactAndreas Müller

Städtisches Klinikum Karlsruhe

andreas.mueller.fk@klinikum-karlsruhe.de+4972197462401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026