Trial Outcomes & Findings for A Comparison of Narrow Band Imaging (NBI) and Standard White Light Laparoscopy to Detect Endometriosis (NCT NCT01464775)

Results Overview

Diagnostic yield in this study is defined as the number of patients undergoing the surgical procedure who are diagnosed, based on pathology, with endometriosis. It is hypothesized that the diagnostic yield will be statistically and significantly higher among patients randomized to white light/NBI compared to those randomized to white light/white light.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

167 participants

Primary outcome timeframe

Day of surgery, day 1

Results posted on

2020-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Narrow Band Imaging (NBI) Women will be randomized to white light/NBI versus white light/white light laparoscopy NBI: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery	White Light Women will be randomized to white light/NBI versus white light/white light laparoscopy White light: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery
Overall Study STARTED	123	44
Overall Study COMPLETED	112	38
Overall Study NOT COMPLETED	11	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Narrow Band Imaging (NBI) and Standard White Light Laparoscopy to Detect Endometriosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Narrow Band Imaging (NBI) n=112 Participants Women will be randomized to white light/NBI versus white light/white light laparoscopy NBI: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery	White Light n=38 Participants Women will be randomized to white light/NBI versus white light/white light laparoscopy White light: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery	Total n=150 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 7.4 • n=5 Participants	30.6 years STANDARD_DEVIATION 7.1 • n=7 Participants	32.5 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	38 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of surgery, day 1

Diagnostic yield in this study is defined as the number of patients undergoing the surgical procedure who are diagnosed, based on pathology, with endometriosis. It is hypothesized that the diagnostic yield will be statistically and significantly higher among patients randomized to white light/NBI compared to those randomized to white light/white light.

Outcome measures

Outcome measures
Measure	Narrow Band Imaging (NBI) n=112 Participants Women will be randomized to white light/NBI versus white light/white light laparoscopy NBI: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery	White Light n=38 Participants Women will be randomized to white light/NBI versus white light/white light laparoscopy White light: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery
Diagnostic Yield	81 participants	25 participants

PRIMARY outcome

Timeframe: Day of surgery, day 1

Sensitivity in this study is defined as the number of lesions biopsied that are determined, based on pathology, to be endometriotic divided by the number of total lesions biopsied. It is hypothesized that the sensitivity for detecting endometriotic lesions will be higher in the white light/NBI arm compared to the white light/white light arm.

Outcome measures

Outcome measures
Measure	Narrow Band Imaging (NBI) n=256 lesions Women will be randomized to white light/NBI versus white light/white light laparoscopy NBI: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery	White Light n=256 lesions Women will be randomized to white light/NBI versus white light/white light laparoscopy White light: Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery
Sensitivity	256 lesions	202 lesions

SECONDARY outcome

Timeframe: 6 weeks, 3 months and 6 months [post surgery]

At each of the follow-up time points (6 weeks, 3 months, 6 months), questionnaires will be administered to the patient in order to quantify existing pain and to assess change in pain from baseline. Measurement tools for pain include a 10 centimeter visual analogue scale and the validated Endometriosis Health Profile (EHP-30).

Outcome measures

Outcome data not reported

Adverse Events

Narrow Band Imaging (NBI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

White Light

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fermin Barrueto

MercyMC

Phone: 410-321-8452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place