Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis

Study 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.

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

Conditions
-----------------
Endometriosis, Bowel Endometriosis, Constipation

Intervention / Treatment
-----------------
* Procedure: Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for bowel endometriosis requiring colorectal resection Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women underwent colorectal resection for endometriosis<br>Women referred for colorectal resection for deep infiltrating endometriosis that underwent laparoscopic segmental colorectal resection performed with mesenteric vascular and nerve sparing surgery. | Procedure: Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection<br>* Laparoscopic segmental colorectal resection performed by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometriosis characteristics | rAFS classification | intraoperative | 
| Complication rate | Number of surgical complications (Clavien-Dindo Classification) | Within 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopy, Colorectal resection, Deep infiltrating endometriosis, Constipation