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

NCT00921778 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2009-06-16

No results posted yet for this study

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

Interventions

DEVICE

Lapcone

Use of Lapcone during LSH

PROCEDURE

laparoscopic supracervical hysterectomy

laparoscopic supracervical hysterectomy

Sponsors & Collaborators

  • Ullevaal University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-12-31
Completion
2011-12-31

Countries

  • Norway

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 NCT00921778 on ClinicalTrials.gov