Appendectomy as an Adjunct Procedure in Endometriosis Surgery

NCT07823777 | Not Yet Recruiting

• 1 other identifier: 1597
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Endometriosis

Keywords

Appendectomy

Outcome Measures

Primary Outcomes (2)

• 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)

  1 year

• Rate of endometriosis lesion recurrence

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

  1 year

Secondary Outcomes (9)

• Change in pelvic pain severity

  6 months

• Change in pelvic pain severity

  6 months

• Change in pelvic pain severity

  1 year

• Postoperative complications

  30 days

• Rate of positive appendiceal pathology

  30 days

Study Arms (3)

Appendectomy

EXPERIMENTAL

Participants randomized to have their appendix removed

Procedure: Appendectomy

No appendectomy

ACTIVE COMPARATOR

Participants randomized to not have their appendix removed

Procedure: Standard of Care (SOC)

Observational Cohort

NO INTERVENTION

Participants will choose whether or not to have their appendix removed during surgery if it appears normal

Interventions

Appendectomy PROCEDURE

Removal of the appendix at the time of endometriosis surgery

Appendectomy

Standard of Care (SOC) PROCEDURE

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

No appendectomy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Abnormal appearing appendix on imaging or intraoperatively
• No endometriosis seen at the time of surgery
• Previous appendectomy
• Menopausal

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

MeSH Terms

Conditions

Endometriosis

Interventions

Appendectomy; Standard of Care

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Olga Bougie, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

416-586-8800; tbd@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, FRCSC. Associate Professor

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share