Appendectomy as an Adjunct Procedure in Endometriosis Surgery (AppEND)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Change in pelvic pain severity
研究概览
简要总结
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.
详细描述
Endometriosis is a chronic inflammatory disease characterized by the growth of endometrial-like tissue outside the uterine cavity, affecting approximately 1 in 10 women and those assigned female at birth during reproductive years. Surgical excision is a cornerstone of endometriosis disease management, particularly in patients with refractory pain, advanced disease, infertility, bowel or urinary tract involvement, or diagnostic uncertainty. However, outcomes are highly variable due to significant variability in surgical approach, underscoring the need for high quality, prospective evidence to optimize surgical intervention.
Appendiceal involvement presents such an opportunity for optimization, which is estimated to impact anywhere from 10-50% of patients in this population. Currently, only appendices that are visually abnormal at the time of surgery are removed. Existing literature, limited to retrospective data, suggests that the addition of appendectomy at the time of endometriosis surgery decreases the risk of postoperative pain and disease recurrence in patients who have received surgical management, regardless of the visual appearance of the appendix.
Notably, visual assessment of the appendix and confirmation of histopathologic appendiceal involvement are not found to be well-correlated.
At this time, there is a lack of quality prospective data to support implementation of adjunct appendectomy into surgical practice. This study aims to bridge this gap by providing the evidence needed to standardize surgical decision-making.
This randomized controlled study will enroll eligible participants between the ages of 18-50 (pre-menopausal), who will undergo laparoscopic or robotic-assisted excision of endometriosis performed by the Minimally Invasive Surgery (MIS) team at Mount Sinai Hospital in Toronto, ON. If the appendix appears normal intraoperatively, the surgeon will proceed with randomized allocation to either appendectomy or no appendectomy. Participants will remain blinded through follow-up, including validated ENDOPAIN-4D questionnaires administered at 6 and 12 months post-operatively and an endometriosis mapping ultrasound at 12 months post-op.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Abnormal appearing appendix on imaging or intraoperatively
- •No endometriosis seen at the time of surgery
- •Previous appendectomy
- •Menopausal
研究组 & 干预措施
No appendectomy
Participants randomized to not have their appendix removed
干预措施: Standard of Care (SOC) (Procedure)
Observational Cohort
Participants will choose whether or not to have their appendix removed during surgery if it appears normal
Appendectomy
Participants randomized to have their appendix removed
干预措施: Appendectomy (Procedure)
结局指标
主要结局
Change in pelvic pain severity
时间窗: 1 year
Change from baseline to 1 year in post-operative pain severity as measured by the ENDOPAIN-4D questionnaire (lower score = less pain)
Rate of endometriosis lesion recurrence
时间窗: 1 year
Rates of recurrence of endometriosis lesions based on 12-month endometriosis mapping ultrasound
次要结局
- 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)
- Types of appendiceal pathology(30 days)
- Operative time(During surgery)
- Postoperative analgesia use(1 year)
- Percentage of eligible participants willing to be randomized(1 year)
研究者
Olga Bougie
MD, MPH, FRCSC. Associate Professor
Mount Sinai Hospital, Canada