Superficial Endometriosis Treatment trial

A randomised, single-blind clinical trial to investigate the effectiveness of bipolar versus monopolar diathermy treatment on pain symptoms for women with newly diagnosed superficial endometriosis: the SET study (Superficial Endometriosis Treatment)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37028168

Enrollment

Registered

2014-05-07

Start date

2014-02-03

Completion date

Unknown

Last updated

2020-09-14

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

Conditions

Gynaecology - Endometriosis Urological and Genital Diseases Endometriosis

Interventions

Two study arms: Monopolar and Bipolar diathermy Monopolar or bipolar diathermy: Generally surgical treatment involves ablation or excision of endometriotic lesions. Ab

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
VAS difference at 4 months post-surgery	—

Secondary

Measure	Time frame
1. VAS difference at 8 months post-surgery. 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). 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). 2. Health state questionnaire change from baseline at 4 and 8 months post surgery. 3. To assess rates or work related sickness at 4 and 8 months post surgery. 4. To assess rates of pain-related admissions to gynaecology during 8 months of follow-up. 5. To describe adverse events, including surgical complications.	—

Measure

Time frame

1. VAS difference at 8 months post-surgery. 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). 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). 2. Health state questionnaire change from baseline at 4 and 8 months post surgery. 3. To assess rates or work related sickness at 4 and 8 months post surgery. 4. To assess rates of pain-related admissions to gynaecology during 8 months of follow-up. 5. To describe adverse events, including surgical complications.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026