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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00921778

Acronym

LSH-LAPCONE

Enrollment

140

Registered

2009-06-16

Start date

2008-09-30

Completion date

2011-12-31

Last updated

2009-06-16

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

Conditions

Vaginal Bleeding

Keywords

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

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).

Interventions

DEVICELapcone

Use of Lapcone during LSH

PROCEDURElaparoscopic supracervical hysterectomy

laparoscopic supracervical hysterectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame
Occurrence of vaginal bleeding 12 months after the procedure.	12 months after operation

Secondary

Measure	Time frame
Patient satisfaction 12 months after the procedure (10-point analogue scale).	12 months after operation

Countries

Norway

Contacts

Primary ContactEspen Berner, MD

espen.berner@uus.no+47 48007701

Backup ContactMarit Lieng, MD

marit.lieng@uus.no+ 47 98606578

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026