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Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03565848
Acronym
IRE-1
Enrollment
50
Registered
2018-06-21
Start date
2022-05-01
Completion date
2024-05-01
Last updated
2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Endometriosis, Constipation, Endometriosis

Keywords

Laparoscopy, Colorectal resection, Deep infiltrating endometriosis, Constipation

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.

Interventions

PROCEDUREMesenteric 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.

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Patients referred for bowel endometriosis requiring colorectal resection

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change in bowel symptoms evaluated by Constipation Assessment ScaleChange from baseline bowel symptoms at 60 days after surgery and at 2 year after surgeryBowel 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 dysuria evaluated by Numeric Rating Scale for PainChange from baseline dysuria at 60 days after surgery and at 1 year after surgeryDysuria 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 PainChange from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgeryPelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain.
Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for PainChange from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgeryDysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain
Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for PainChange from baseline dyschezia at 60 days after surgery and at 1 year after surgeryDyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain
Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for PainChange from baseline dyspareunia at 60 days after surgery and at 1 year after surgeryDyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain.

Secondary

MeasureTime frameDescription
Complication rateWithin 6 months after surgeryNumber of surgical complications (Clavien-Dindo Classification)
Endometriosis characteristicsintraoperativerAFS classification

Contacts

Primary ContactAntonio Simone Laganà, M.D.
antoniosimone.lagana@asst-settelaghi.it00393296279579
Backup ContactSimone Garzon
simone.garzon@univr.it00393470782287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026