Status:
UNKNOWN
TMMR (Total Mesometrial Resection) Register Study
Lead Sponsor:
University Hospital, Essen
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
TMMR/tLNE was shown to result in very low locoregional recurrence rates and low morbidity in surgical treatment of cervical cancer stage IB-IIA without any adjuvant radiotherapy even in high risk situ...
Detailed Description
Rationale for the multimodal treatment of cervical cancer in FIGO stages IB-IIA according to M. Hoeckel: Total mesometrial resection (TMMR) is a newly developed procedure for surgical treatment of cer...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically proven cervical cancer: squamous cell carcinoma or adenocarcinoma; FIGO stages IB - IIA (preoperatively); Karnofsky-Index ≥ 70; unrestricted operability; BMI \<35; age \>=18 years.
- Individual decision for treatment of TMMR and therapeutic LNE without adjuvant radiotherapy by the responsible clinic (clinician) on a clinical routine basis.
- Informed consent of the patient
- Exclusion criteria:
- Neuroendocrine differentiation and all preoperative FIGO stage IA or \>IIA;
- Distant metastases except in para-aortic lymph nodes; sclerodermia, lupus erythematodes, mixed connective tissue disease; secondary malignancy; previous radiotherapy of the pelvis.
- Patients with diseases of the connective tissue will be excluded because of unforeseeable (e.g. neurological) symptoms and disorders after surgery. Patients with a BMI ≥ 35 will be excluded because of very high risks regarding wound healing, infections and thrombosis independent on the type of surgery.
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01819077
Start Date
March 1 2013
End Date
March 1 2018
Last Update
May 27 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Essen
Essen, North Rhine-Westphalia, Germany, 45122