Superficial Endometriosis Treatment trial

Not Applicable

Completed

• Conditions: Gynaecology - Endometriosis; Urological and Genital Diseases; Endometriosis

• Registration Number: ISRCTN37028168
• Lead Sponsor: Portsmouth Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-07
• Study Completion: 2015-08-01
• Last Update Posted: 14 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Preoperative
The patient must meet ALL of the following criteria to be considered eligible for the study:
1. Female
2. Aged 18 years and above.
3. Scheduled for diagnostic laparoscopy due to history of pelvic pain (clinical suspicion of endometriosis)
4. Willing and able to give informed consent for participation in the study

Intraoperative
The participant must meet ALL of the following criteria to be considered eligible for the study:
Superficial endometriosis found at laparoscopy, defined by Stage I or II of the revised American Fertility Society rAFS score.

Exclusion Criteria

Preoperative
The patient may not enter the study if ANY of the following apply:
1. Previous diagnosis of endometriosis from previous surgery/assessment
2. If language or competency barriers exist during consenting

Intraoperative
The participant may not enter the study if ANY of the following apply:
1. Position of endometriosis contraindicates use of either diathermy treatment due to risk of complications, e.g. endometriosis vesicle over the ureter

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS difference at 4 months post-surgery

Secondary Outcome Measures

Name	Time	Method
<br> 1. VAS difference at 8 months post-surgery.<br> 1.1. Overall VAS (average) changes from baseline at 4 and 8 months post-surgery in combined pain domains (Dyspareunia, chronic pelvic pain, menstrual pain).<br> 1.2. Individual VAS change from baseline at 4 and 8 months post-surgery in separate domains of pain domains (Dyspareunia, chronic pelvic pain, menstrual pain).<br> 2. Health state questionnaire change from baseline at 4 and 8 months post surgery.<br> 3. To assess rates or work related sickness at 4 and 8 months post surgery.<br> 4. To assess rates of pain-related admissions to gynaecology during 8 months of follow-up.<br> 5. To describe adverse events, including surgical complications.<br>