Status:
UNKNOWN
Feasibility of a Trial of Laparoscopic Hysterectomy Versus Laparoscopic Sub-Total Hysterectomy
Lead Sponsor:
Medway NHS Foundation Trust
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Benign Disease of the Uterus
Eligibility:
FEMALE
18-54 years
Phase:
NA
Brief Summary
Observational studies suggest faster recovery and quicker return to normal activities following laparoscopic supracervical hysterectomy (LSH which involves removal of the body of the womb but conserva...
Detailed Description
Hysterectomy remains the last resort for a number of benign conditions which have failed to respond to conservative measures. Hysterectomy is also performed for operable gynaecological malignancy whic...
Eligibility Criteria
Inclusion
- Hysterectomy indicated for benign indications
- Premenopausal
Exclusion
- Post menopausal women
- Suspected malignancy
- Abnormal cervical smears or a history of treatment of a high grade cervical intraepithelial neoplasia within 3 years of recruitment.
- Raised BMI (Body Mass Index) \> 35Kg/M2
- Uterovaginal prolapse \> Stage 1 (Bump et al 1996).
- Previous gynaecological malignancy
- Previous extensive pelvic surgery
- Psychological/psychiatric disease
- Anti-depressant/anti-psychotic therapy
- Unable to read and write English
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01825915
Start Date
September 1 2010
End Date
May 1 2013
Last Update
April 8 2013
Active Locations (1)
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1
Medway NHS Foundation Trust
Gillingham, Kent, United Kingdom, ME7 5NY