Endometriosis Clinical Trial
— IRE-1Official title:
Analysis of Surgical Outcomes in Women Undergoing Mesenteric Vascular and Nerve Sparing Surgery in Laparoscopic Segmental Colorectal Resection for Deep Infiltrating Endometriosis
NCT number | NCT03565848 |
Other study ID # | IRE-1 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | May 1, 2024 |
Colorectal resection is a standard surgical treatment of bowel deep infiltrating endometriosis (DIE). Nevertheless, concerns about different bowel functional outcomes related to radical surgery versus conservative surgery as shaving technique is a topic leading to much debate. Different surgical approach are used to perform colorectal resection and there is not a standardized technique. For the same concerns, studies have addressed the mesenteric vascular and nerve preservation both in oncological and benign intestinal disease with improved functional outcome. Therefore, the aim of this prospective study is to analyze feasibility and safety of mesenteric vascular and nerve Sparing Surgery in laparoscopic segmental colorectal resection for DIE with short and long term follow up. Women with DIE ,that underwent laparoscopic segmental colorectal resection, will undergo resection performed with inferior mesenteric artery and branching arteries preservation by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved. Personal history, clinical data, surgical data, short and long term surgical complications and long term outcomes will be recorded. Symptoms and bowel function will be evaluated before and after surgery.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2024 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: - Patients referred for bowel endometriosis requiring colorectal resection Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi dell'Insubria |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain | Dysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain | Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery | |
Primary | Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain | Dyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain | Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery | |
Primary | Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain | Dyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain. | Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery | |
Primary | Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain | Dysuria in 0 - 10 range according to the Numeric Rating Scale for Pain. | Change from baseline dysuria at 60 days after surgery and at 1 year after surgery | |
Primary | Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain | Pelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain. | Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery | |
Primary | Change in bowel symptoms evaluated by Constipation Assessment Scale | Bowel symptoms in 0 - 16 range according to the Constipation Assessment Scale. Constipation Assessment Scale includes eight items, each of which is self-rated by the patient as 'no problem' (score of 0), 'some problem' (score of 1), or 'severe problem' (score of 2). The item ratings are then summed, so the overall score may range from 0 (no constipation) to 16 (worst possible constipation). | Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery | |
Secondary | Endometriosis characteristics | rAFS classification | intraoperative | |
Secondary | Complication rate | Number of surgical complications (Clavien-Dindo Classification) | Within 6 months after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01931670 -
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Recruiting |
NCT05648669 -
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Completed |
NCT04081532 -
The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain
|
N/A | |
Recruiting |
NCT06101303 -
Endometriosis Pain
|
||
Completed |
NCT04665414 -
Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
|
||
Completed |
NCT03690765 -
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
|
||
Recruiting |
NCT05153512 -
ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
|
||
Active, not recruiting |
NCT04171297 -
Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
|
||
Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
Completed |
NCT04565470 -
Strategies of Self-management of Endometriosis Symptoms
|
||
Completed |
NCT03613298 -
Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
|
N/A | |
Withdrawn |
NCT05568940 -
Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
|
||
Not yet recruiting |
NCT03464799 -
Does Immunotherapy Have a Role in the Management of Endometriosis?
|
||
Active, not recruiting |
NCT03002870 -
Characteristics of Patient Population With Endometriosis
|
N/A | |
Completed |
NCT02973854 -
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
|
||
Withdrawn |
NCT03272360 -
Endometriosis Biomarker Discovery Study
|
N/A | |
Recruiting |
NCT02481739 -
Laparoscopic Surgical Management of Endometriosis on Fertility
|
N/A | |
Active, not recruiting |
NCT02754648 -
Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
|
N/A | |
Completed |
NCT06106932 -
GnRH-a on Angiogenesis of Endometriosis
|
N/A | |
Completed |
NCT02387931 -
Supplementation in Adolescent Girls With Endometriosis
|
Phase 4 |