Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern

NCT00921778 | Unknown

• 1 other identifier: LSH-LAPCONE UUS
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The occurrence of persistent vaginal bleeding following laparoscopic supracervical hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists have claimed that removal of any remaining endometrium in a reverse cone pattern at the time of the hysterectomy reduces the occurrence of persistent vaginal bleeding to a minimum. The effect of this particular technique has not been reported. Ullevaal University Hospital have developed an unipolar electrode for this study (Lapcone electrode, mod. UUS, L: 25cm, 6x10, Art. No. REM-270, Ross Electro Medical Ltd, Unit K1\&K2, Quarry Fields Estate, Mere, Wiltshire BA12 6LA, London, UK). The electrode is CE approved. Outcome: 1.Occurrence of vaginal bleeding 12 months after the procedure. 2. Patient satisfaction 12 months after the procedure (10-point analogue scale). Design: Prospective randomised trial. Methods; The study participants are randomised to laparoscopic supracervical hysterectomy performed by perioperative electrocoagulation from the upper cervical canal (n=70) or performed by excision of the endocervix in a reverse cone pattern followed by electrocoagulation of the upper cervical canal (n =70).

Conditions

Vaginal Bleeding

Keywords

Laparoscopic supracervical hysterectomy; Vaginal bleeding; Patient satisfaction; vaginal bleeding after laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• Occurrence of vaginal bleeding 12 months after the procedure.

  12 months after operation

Secondary Outcomes (1)

• Patient satisfaction 12 months after the procedure (10-point analogue scale).

  12 months after operation

Interventions

Lapcone DEVICE

Use of Lapcone during LSH

laparoscopic supracervical hysterectomy PROCEDURE

laparoscopic supracervical hysterectomy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All premenopausal women who are referred to the departement due to a benign condition requiring hysterectomy and who have given informed consent are eligible for study recruitment

You may not qualify if:

• Women who are unable to communicate in written Norwegian or oral English language.
• Woman with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative smear or wtih atypical hyperplasia og malignancy in preoperative endometrial biopsy
• Women who after a thorough clinical evaluation are found to be more suited for vaginal, abdominal or total hysterectomy
• Women with a coexisting condition requiring no remaining ovaries after the procedure
• Postmenopausal women
• Women using hormone therapy (HT)

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Ullevaal University Hospital

Oslo, Norway

RECRUITING

Related Links

• homepage Ullevaal University Hospital

MeSH Terms

Conditions

Uterine Hemorrhage; Patient Satisfaction

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Espen Berner, MD

CONTACT

+47 48007701; espen.berner@uus.no

Marit Lieng, MD

CONTACT

+ 47 98606578; marit.lieng@uus.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: September 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: June 16, 2009

Record last verified: 2008-08

Locations

NO (1)