Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03532074
Other study ID # 290/2017/O/Sper
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 28, 2018
Est. completion date November 2019

Study information

Verified date June 2019
Source Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact DIEGO RAIMONDO
Phone 00390512144385
Email DIE.RAIMONDO@GMAIL.COM
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Indocyanine green is a fluorescent dye used for the intraoperative evaluation of tissue perfusion.

The aim of this study is to evaluate a possible correlation between rectosigmoid vascularization and surgical and clinical data including pre and post-operative bowel symptoms in patients needing surgery for rectosigmoid endometriosis.


Description:

Patients with symptomatic rectosigmoid endometriosis requiring laparoscopic surgery are included in the study.

Before surgery, bowel symptoms are assessed using validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index).

Indocyanine green is administered through peripheral line. A near-infrared (NIR) camera-head enables real-time direct visualization of bowel perfusion before and after the removal of the rectosigmoid nodule. Rectosigmoid tract perfusion is assessed before and after the removal of the nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used.

After complete removal of rectosigmoid nodule, the post-operative follow-up will be the same as usual after intestinal endometriosis surgery. Postoperative bowel symptoms are evaluated using the same questionnaires.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Diagnosis of deep endometriosis based on clinical and transvaginal/transabdominal ultrasound examinations and, when necessary, magnetic resonance

- Patients with indication for removal of endometriosic lesions by laparoscopic surgery

- Obtaining Informed Consent

Exclusion Criteria:

- Known or suspected allergy to iodine

- Previous rectal surgery

- History of active pelvic infection

- Intra-abdominal or pelvic malignancy

- Pelvic radiation therapy

- Hyperthyroidism

- Liver dysfunction

- Serum creatinine > 2.0 mg/dL

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
assessment of bowel symptoms before surgery
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery
assessment of rectosigmoid during laparoscopy
indocyanine green (0.25 mg/kg) is administered through peripheral line. A near-infrared camera-head (KARL STORZ Gesellschaft mit beschränkter Haftung & Co., Tuttlingen, Germany) is used to visualize bowel perfusion before and after the removal of the rectosigmoid nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used
follow up and assessment of bowel symptoms after surgery
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis after surgery
assessment of rectosigmoid perfusion during robot-assisted laparoscopy
indocyanine green (0.25 mg/kg) is administered through peripheral line. The robotic Firefly imaging system (daVinciXi surgical platform; Intuitive Surgical, Sunnyvale, CA) is used to visualize bowel perfusion before and after the removal of the rectosigmoid nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used

Locations

Country Name City State
Italy Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital Bologna

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal comparison between bowel symptoms, assessed through validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) and rectosigmoid perfusion, measured before the nodule removal using indocyanine green and a scale from 0 to 4. intraoperative
Secondary correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal comparison between rectosigmoid perfusion, measured after the nodule removal using indocyanine green and a scale from 0 to 4, and bowel symptoms, assessed through validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index). up to three months after surgery
Secondary correlation between bowel perfusion after rectal surgery and post-operative complications assessment of rectosigmoid perfusion, through indocyanine green and a scale from 0 to 4, and complications (rectovaginal fistula, dehiscence of anastomotic suture, rectal bleeding, rectosigmoid perforation, rectosigmoid stenosis), using Clavien-Dindo Classification. up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Withdrawn NCT03481842 - Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis Phase 1/Phase 2
Completed NCT03138954 - Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement
Completed NCT04411004 - Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis
Completed NCT04338035 - Fertility in Untreated Rectosigmoid Endometriosis
Active, not recruiting NCT01291576 - Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum N/A
Completed NCT04295343 - Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
Recruiting NCT04398641 - Surgery for Lower Rectum Deep Endometriosis (Segmental/Disc) - Prospective Comparison of Digestive Symptoms and Pain
Active, not recruiting NCT04339946 - Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis
Completed NCT04296760 - Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
Completed NCT04406155 - Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis
Recruiting NCT04891003 - The Identification of Optimal Ultrasonografic Tecniques for Determining the Location , Size and the Surgical Methods of Intestinal Endometriotric Nodules
Recruiting NCT05677269 - The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Active, not recruiting NCT04204707 - Patient Reported Outcomes After Surgery for Rectal Endometriosis
Completed NCT04494568 - Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis N/A
Not yet recruiting NCT04491305 - EHP-5 in Preoperative Assessment in Women With Endometriosis