A pilot feasibility multicenter study of patients after excision of  endometriosis

Patrick Yeung Jr; Frank Tu; Krisztina Bajzak; Georgine Lamvu; Olga Guzovsky; Rob Agnelli; Mary Peavey; Wendy Winer; Robert Albee; Ken Sinervo

doi:10.4293/108680812X13517013317833

Endometriosis Surgical Treatment

A pilot feasibility multicenter study of patients after excision of endometriosis

Yeung PP Jr, Tu F, Bajzak K, Lamvu G, Guzovsky O, Agnelli R, Peavey M, Winer W, Albee R, Sinervo K

Published June 8, 2013 JSLS : Journal of the Society of Laparoendoscopic Surgeons, 17(1), 88-94

DOI 10.4293/108680812X13517013317833 PMID 23743377 PMC PMC3662751

RRM Academy Synopsis

Pain and quality of life improved after endometriosis excision

Women with confirmed endometriosis had less pain and better quality of life after excision surgery. A pilot study at five centers enrolled 100 women. 90 had surgery, and 65 of those 90 had confirmed disease. 84 of 100 women said they would join a future trial comparing excision and ablation.

About 8 in 10 women said they would join a randomized trial of excision versus ablation. Source: Yeung PP Jr et al., 2013, PMID 23743377.

Study at a glance, pilot study of 100 women: Pain and quality of life improved after endometriosis excision. Source: Yeung PP Jr et al., 2013, PMID 23743377.

Key Findings

100 women enrolled at 5 referral centers. 90 had excision, 65 of 90 (72.2%) had histologically confirmed endometriosis, and 55 of 90 (61.1%) completed a postoperative questionnaire.
In women with confirmed endometriosis, pain scores fell significantly for pelvic pain, dysmenorrhea, dyspareunia and bladder symptoms, but not bowel symptoms. Mean pelvic pain went from 5.2 to 2.4.
In these women, quality of life scores rose significantly, from 63.3 before surgery to 83.3 after, on a scale from 0 to 100. Mean time to follow-up was 8.5 months.
84.0% (84 of 100) of women who completed the initial questionnaire were willing to join a randomized trial of laparoscopic excision versus ablation.
Women who had hormonal suppression after excision showed no significant difference in change in pain scores or quality of life compared with women who had none.

Interpretation

This pilot study followed 100 women with pelvic pain at five centers. 90 of them had excision surgery. Pain scores dropped for pelvic pain, painful periods, painful sex and bladder symptoms. Quality of life scores rose from 63.3 to 83.3 on a 100-point scale. 84 of 100 women said they would join a future trial comparing excision and ablation. The authors note the study had no process to confirm that excision was complete at each site. The findings support a larger trial of excision versus ablation, with quality of life as the main result.

RRM Context

Excision removes the lesion and sends it to a lab for testing. That is how doctors confirmed disease in 72.2% of the women who had surgery. Every woman in this study had pelvic pain that did not improve with at least one type of medical treatment. Restorative reproductive medicine treats the disease itself. Excision is the surgical approach RRM endorses over ablation.

Our editorial summary of this paper, not the article's abstract.

Abstract

Objective

To serve as a pilot feasibility study for a randomized study of excision versus ablation in the treatment of endometriosis by (1) estimating the magnitude of change in symptoms after excision only at multiple referral centers and (2) determining the proportion of women willing to participate in a randomized trial.

Methods

We performed a multicenter prospective study of women undergoing excision for endometriosis (Canadian Task Force class II-3) at Duke University Center for Endometriosis Research & Treatment (currently the Saint Louis University Center for Endometriosis), Center for Endometriosis Care, Northshore University Health System, Memorial University (Canada), and Florida Hospital. The study comprised 100 female patients, aged 18 to 55 years, with endometriosis-suspected pelvic pain. The intervention was laparoscopic excision only of the abnormal peritoneum suspicious for endometriosis. The main outcome measures were quality of life, pelvic pain, dysmenorrhea, dyspareunia, and bowel and bladder symptoms.

Results

The mean follow-up period was 8.5 months. Excision of endometriosis showed a significant reduction in all pain scores except bowel symptoms, as well as significant improvement in quality of life. Of the patients, 84% were willing to participate in a randomized study.

Conclusions

Quality of life is a needed primary outcome for any randomized study comparing excision versus ablation. A multicenter comparative trial is feasible, although quality assurance would have to be addressed. Patients were willing to be randomized even at surgical referral centers.

Read the guide

Endometriosis Explained: Diagnosis, Excision Surgery, and the RRM Approach

Topics

Endometriosis › Surgical Treatment › Excision Surgery · General Gynecology › Pelvic Pain › Chronic Pelvic Pain · Research Methods › Study Design › Cohort Studies

Patrick Yeung Jr, Frank Tu, Krisztina Bajzak, Georgine Lamvu, Olga Guzovsky, Rob Agnelli, Mary Peavey, Wendy Winer, Robert Albee, Ken Sinervo

Pat Yeung, P Yeung, F Tu, K Bajzak, G Lamvu, O Guzovsky, Robert Agnelli, R Agnelli, M Peavey, W Winer, Bob Albee, Rob Albee, Bobby Albee, R Albee, Kenneth Sinervo, K Sinervo

PMID 23743377 23743377 DOI 10.4293/108680812X13517013317833 10.4293/108680812X13517013317833 Yeung Jr et al. 2013, Yeung Jr 2013