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Butterfly Feasibility Trial; comparison of two surgical treatment approaches for early stage endometriosis.

The Butterfly Randomised Controlled Feasibility (open pilot) trial; recruitment to a comparison of two surgical treatments for stage I – II endometriosis.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000622303
Enrollment
20
Registered
2026-05-21
Start date
2026-07-06
Completion date
2027-05-04
Last updated
2026-05-25

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

Conditions

None listed

Brief summary

This feasibility study will assess whether it is possible to recruit to a proposed surgical treatment trial and provide baseline scores from the planned outcome measurement tools. The proposed single-blinded randomised controlled trial (The Butterfly study) will compare two current surgical interventions for women aged 18 - 50 with stage I-II endometriosis and pelvic pain. These are standard care (laparoscopic spot excision of macroscopic endometriosis) versus standard care plus posterior peritonectomy. Posterior peritonectomy involves removing the lining of the pelvis (the peritoneum) in the pelvis behind the uterus. The primary outcome for the feasibility trial is the number of participants randomised in 12 months.

Interventions

The interventional arm of the trial will be standard excisional treatment of endometriosis plus a posterior peritonectomy to determine whether the addition of posterior peritonectomy improves overall pain and quality of life at one year. If the participant is allocated to posterior peritonectomy, this will be performed with the instruments of the surgeon’s choice, with the margins defined as extending from the level of the infundibular pelvic ligament down to the Pouch of Douglas including the

The interventional arm of the trial will be standard excisional treatment of endometriosis plus a posterior peritonectomy to determine whether the addition of posterior peritonectomy improves overall pain and quality of life at one year. If the participant is allocated to posterior peritonectomy, this will be performed with the instruments of the surgeon’s choice, with the margins defined as extending from the level of the infundibular pelvic ligament down to the Pouch of Douglas including the ovarian fossae and the uterosacral ligament peritoneum bilaterally. Peritoneum will be divided into ovarian fossae, uterosacral peritoneum and Pouch of Douglas and sent for histology. The posterior peritonectomy is anticipated to take an additional 10minutes of surgical time. Following completion of the procedure an anti-adhesion fluid (Adept) will be instilled into the pelvis for all patients. If concurrent gynaecological procedures were required such as tubal dye studies, ovarian cystectomy or hysteroscopy these can be performed in both study arms. Surgeons are asked at the end of the operation whether they have complied with the randomised allocation, which is entered into the research database. Histology will be checked to confirm the areas and size of peritoneum removed.

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria pre-surgery (potentially eligible) -Biological female, age 18–50 years -Undergoing laparoscopy for pelvic pain with suspected rASRM stage I-II endometriosis -No previous surgical treatment for endometriosis (diagnostic laparoscopy + biopsy ok) -Surgeon has capability to undertake both study procedures Randomised controlled trial inclusion criteria – at surgery -On laparoscopic entry into the pelvis, rASRM stage I – II endometriosis confirmed -Consented to randomisation

Exclusion criteria

Exclusion Criteria pre-surgery -Previous hysterectomy or bilateral oophorectomy -Pregnancy -Presumed stage III-IV endometriosis pre-operatively (eg diagnosed by ultrasound)

Outcome results

None listed

Source: ANZCTR · Data processed: May 30, 2026