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Clinical Trials/NCT03565848
NCT03565848
Unknown
Not Applicable

Analysis of Surgical Outcomes in Women Undergoing Mesenteric Vascular and Nerve Sparing Surgery in Laparoscopic Segmental Colorectal Resection for Deep Infiltrating Endometriosis

Università degli Studi dell'Insubria0 sites50 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Università degli Studi dell'Insubria
Enrollment
50
Primary Endpoint
Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
May 1, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Università degli Studi dell'Insubria
Responsible Party
Principal Investigator
Principal Investigator

Antonio Simone Laganà

Medical Doctor

Università degli Studi dell'Insubria

Eligibility Criteria

Inclusion Criteria

  • Patients referred for bowel endometriosis requiring colorectal resection

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain

Time Frame: Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery

Dyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain

Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain

Time Frame: Change from baseline dysuria at 60 days after surgery and at 1 year after surgery

Dysuria in 0 - 10 range according to the Numeric Rating Scale for Pain.

Change in bowel symptoms evaluated by Constipation Assessment Scale

Time Frame: Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery

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 in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain

Time Frame: Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery

Dysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain

Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain

Time Frame: Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery

Dyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain.

Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain

Time Frame: Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery

Pelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain.

Secondary Outcomes

  • Endometriosis characteristics(intraoperative)
  • Complication rate(Within 6 months after surgery)

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