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The Role of Expectations on Complaints and Well-being After Endometriosis Surgery in Women

NCT05019612 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-01-24

No results posted yet for this study

Summary

Endometriosis is a prevalent disease in women of procreative age. Most endometriosis patients are affected in their daily life by complaints such as chronic pelvic pain, dysmenorrhoea, infertility, or pain during sexual intercourse. Yet, its etiology is poorly understood. Although laparoscopy is well known as the gold standard for treating endometriosis, 20-30% of treated women still show persistent complaints following successful laparoscopy.

It has been widely recognized that expectations profoundly affect treatment courses and outcomes in many different health conditions. Additionally, evidence suggests that optimizing preoperative expectations can improve post-operative outcomes such as disability and return to work.

The objective of this study is to investigate whether expectations also affect treatment course and outcome in women after endometriosis surgery. For this purpose, the investigators conduct a mixed-method observational cohort study to gather data on psychological factors, particularly treatment and symptom-related expectations, as well as complaints and well-being of patients after surgery. A sample of N = 300 women will be asked pre- and postoperatively to evaluate these psychological factors and indicators of treatment course and outcome. Overall, the study will last 12 months, including one assessment preoperatively (baseline), seven monthly assessments postoperatively, and a follow-up assessment 12 months after endometriosis surgery.

The study aims to determine potential interactions between aforementioned psychological factors, their influence on the postoperative health, and the long- and short-term symptom course of patients with endometriosis. The study results will provide a better understanding of the symptom- and treatment course in women with endometriosis and subsequently supply clinical approaches to optimize treatment of endometriosis.

Conditions

  • Endometriosis
  • Expectations
  • Laparoscopy

Interventions

PROCEDURE

Laparoscopy: A minimal invasive surgery

A low-risk minimal invasive surgery performed in the pelvis using small incisions. With the aid of a laparoscope, the operator views the affected area in real-time. Beyond that, the camera sends images to a video monitor. The operator obtains endometriosis and biopsy samples with small surgical instruments. Before laparoscopy, individuals are provided with a general anaesthetic to relax muscles and prevent pain during surgery.

Sponsors & Collaborators

  • Frauenklinik an der Elbe

    collaborator UNKNOWN

  • Helmut Schmidt University

    lead OTHER

Principal Investigators

  • Yvonne Nestoriuc, Prof. Dr. · Helmut Schmidt University/ University of the Federal Armed Forces Hamburg

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2024-06-20
Completion
2024-06-20

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05019612 on ClinicalTrials.gov