NCT04752241

Brief Summary

This study aims to evaluate whether IMA sparing may represent an advantage in terms of reduced incidence and severity of sexual dysfunctions after colorectal resections for diverticular disease (DD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

6 years

First QC Date

February 8, 2021

Last Update Submit

July 21, 2024

Conditions

Sexual Function Disturbances

Keywords

Sexual functionColonic diverticular diseaseInferior mesenteric artery-preservingNeosigmoid DenervationPostoperative sexual dysfunction

Outcome Measures

Primary Outcomes (2)

  • Sexual disfunction 1

    Presence of sexual disfunction ( defined through the evaluation of sexual desire ,arousal, lubrication , orgasmic function, overall satisfaction, pain, intercourse satisfaction , erectile function)

    12 months after surgery

  • Sexual disfunction 2

    Presence of sexual disfunction ( defined through the evaluation of sexual desire ,arousal, lubrication , orgasmic function, overall satisfaction, pain, intercourse satisfaction , erectile function)

    6 years after surgery

Secondary Outcomes (8)

  • Sexual Function Male 1

    12 month after surgery

  • Sexual Function Male 2

    6 years after surgery

  • Sexual Function Female 1

    12 months after surgery

  • Sexual Function Female 2

    6 years after surgery

  • Quality of Life 1

    12 months after surgery

  • +3 more secondary outcomes

Study Arms (2)

IMAP

EXPERIMENTAL

Inferior Mesenteric Artery Preservation Performing left hemicolectomy and anterior rectal resection the IMA was preserved ligating close to the colonic wall the sigmoids arteries.

Procedure: Inferior Mesenteric Artery Preservation

IMAS

ACTIVE COMPARATOR

Inferior Mesenteric Artery Ligation Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

Procedure: Inferior Mesenteric Artery Ligation

Interventions

Inferior Mesenteric Artery PreservationPROCEDURE

Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.

IMAP
Inferior Mesenteric Artery LigationPROCEDURE

Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

IMAS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diverticular disease
  • Diverticulitis
  • BMI under 35 Kg/mq
  • ASA score from I to III
  • Standardized sigmoid, left colon or rectal resection

You may not qualify if:

  • complicated diverticulitis (Hinchey III-IV)
  • previous abdominal surgery or prostatic and/or gynecological resections
  • adverse local condition or the need of multiorgan resection or stoma creation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Sant'Andrea

Rome, 00188, Italy

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 12, 2021

Study Start

January 1, 2012

Primary Completion

January 1, 2018

Study Completion

January 1, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)