A double blinded randomised controlled study on the effect of laparoscopic excision on endometriosis

Not Applicable

Completed

• Conditions: Endometriosis / pelvic pain; Surgery - Surgical techniques; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12611000251921
• Lead Sponsor: Dr Jason Abbott

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

Pelvic pain (of greater than six months duration) with suspected endometriosis
Examination findings suggestive of endometriosis
AUltrasound findings suggestive of an endometrioma.
BRectal ultrasound findings suggestive of infiltrative endometriosis such as uterosacral or rectal wall involvement.
CPrevious diagnostic or operative laparoscopy with visual suggestion of, or biopsy proven, disease.

Exclusion Criteria

1.Suspected diagnosis of gynaecological malignancy or its precursors.
2.Current or chronic relapsing pelvic inflammatory disease.
3.Current pregnancy.
4.Infertility and endometriosis without pelvic pain.
5.Unable to give informed consent.
6.Unable or unwilling to attend for both surgeries and for follow-up to twelve months.
7.No histological confirmation of endometriosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessment using visual analogue scales and validated questionnaires[12 months after surgery];Quality of life assessed by quality of life validated questionnaires[12 months from surgery]

Secondary Outcome Measures

Name	Time	Method
analgesia requirement by assessing total amount of medication required in the post operative period in hospital using the patient's medication charts[1 week following surgery];Hospital stay by assessing hours of admission to the hospital and ward based on hospital records[1 week follwing surgery];Fertility assessed by questionnaire and medical records of consultation[12 months following surgery]