Clinical trial NCT03565848: Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis
Official title: Analysis of Surgical Outcomes in Women Undergoing Mesenteric Vascular and Nerve Sparing Surgery in Laparoscopic Segmental Colorectal Resection for Deep Infiltrating Endometriosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Bowel Endometriosis
Constipation
Keywords: Laparoscopy
Colorectal resection
Deep infiltrating endometriosis
Constipation
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with deep infiltrating endometriosis underwent laparoscopic surgery treatment with segmental intestinal resection.

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.


Eligibility criteria: Inclusion Criteria:

* Patients referred for bowel endometriosis requiring colorectal resection

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain
timeFrame: Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery
measure: Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain
timeFrame: Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery
measure: Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain
timeFrame: Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery
measure: Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain
timeFrame: Change from baseline dysuria at 60 days after surgery and at 1 year after surgery
measure: Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain
timeFrame: Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery
measure: Change in bowel symptoms evaluated by Constipation Assessment Scale
timeFrame: Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery
Secondary outcomes:
measure: Endometriosis characteristics
timeFrame: intraoperative
measure: Complication rate
timeFrame: Within 6 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Universita di Verona
name: Simone Garzon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uninsubria
name: Antonio Simone Laganà, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Paola Pomini, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Massimo Franchi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: