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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date September 2021
Source Università degli Studi dell'Insubria
Contact Antonio Simone Laganà, M.D.
Phone 00393296279579
Email antoniosimone.lagana@asst-settelaghi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection
Laparoscopic segmental colorectal resection performed by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Outcome

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
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