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Appendectomy as an Adjunct Procedure in Endometriosis Surgery

ConditionEndometriosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMount Sinai Hospital, Canada

About this trial

This study addresses a common but unresolved clinical decision in endometriosis surgery: whether to perform an adjunct appendectomy. Currently, this decision is often based on individual surgeon judgement or institutional practice rather than robust evidence.

This randomized controlled study aims to determine if removing a normal appearing appendix at the time of endometriosis surgery impacts post-operative recurrence of pelvic pain and endometriotic lesions at 12 months. Secondary outcomes include pathology of the appendix and complication rate of the procedure.

Participants will be randomized to appendectomy or no appendectomy at the time of their planned endometriosis surgery. The study also includes an observational cohort that participants may opt to join if they do not wish to be randomized.

Data are expected to guide surgical decision-making and contribute to the development of standardized surgical guidelines.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-50 years

Endometriosis diagnosis based on imaging or prior surgical findings

Baseline pain above 3 on the Numerical Rating Scale (NRS)

Undergoing surgical excision of endometriosis only, with at least one remaining ovary

Disqualifiers

Abnormal appearing appendix on imaging or intraoperatively

No endometriosis seen at the time of surgery

Previous appendectomy

Menopausal

Trial design

Design model

Parallel

Treatments tested in this trial

  • Appendectomy

    Procedure/Surgery

    Removal of the appendix at the time of endometriosis surgery

  • Standard of Care (SOC)

    Procedure/Surgery

    If the appendix appears normal during surgery it will not be removed

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: AppendectomyExperimental treatment 1 intervention
Group B: No appendectomyActive comparator 1 intervention
Group C: Observational CohortNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in pelvic pain severity

Change from baseline to 1 year in post-operative pain severity as measured by the ENDOPAIN-4D questionnaire (lower score = less pain)

Time frame
1 year
2

Rate of endometriosis lesion recurrence

Rates of recurrence of endometriosis lesions based on 12-month endometriosis mapping ultrasound

Time frame
1 year

Secondary outcomes

1

Change in pelvic pain severity

Change from baseline to 6 months in post-operative pain severity as measured by the ENDOPAIN-4D questionnaire (lower score = less pain)

Time frame
6 months
2

Change in pelvic pain severity

Change from baseline to 6 months in post-operative pain severity as measured by the Numerical Rating Scale (NRS; lower score = less pain)

Time frame
6 months
3

Change in pelvic pain severity

Change from baseline to 1 year in post-operative pain severity as measured by the Numerical Rating Scale (NRS; lower score = less pain)

Time frame
1 year
4

Postoperative complications

Postoperative analgesia use, sleep disturbances, and lifestyle impact at 30 days, reported by participant

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mount Sinai Hospital, Canada

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: