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Completed

NCT Number: NCT04752241

Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease

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).

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Key information

Conditions

Sexual Function Disturbances Mental Disorders Sexual Dysfunctions, Psychological

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Sant'Andrea

Rome, 00188, Italy

About this study

Enrolled patients were randomly divided into 2 treatment groups. In the first group (IMAP) the IMA was preserved sectioning the sigmoid arteries near colonic wall while, in the second group (IMAS) the IMA was sectioned immediately below the origin of the left colic artery. Incidence and severity of sexual dysfunction and QoL were assessed by four validated questionnaire administered 6,12 months and 5 and 8 years after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Inferior Mesenteric Artery Preservation

Procedure

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

Inferior Mesenteric Artery Ligation

Procedure

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

Primary outcomes

  1. Sexual disfunction 1

    Time frame: 12 months after surgery

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

  2. Sexual disfunction 2

    Time frame: 6 years after surgery

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

Secondary outcomes

  1. Sexual Function Male 1

    Time frame: 12 month after surgery

    assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test

  2. Sexual Function Male 2

    Time frame: 6 years after surgery

    assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test

  3. Sexual Function Female 1

    Time frame: 12 months after surgery

    assess the patients' sexual disorders withFemale Sexual Function Index (FSFI) a 19-item test (score below 26.55 indicates the presence of sexual dysfunctions)

  4. Sexual Function Female 2

    Time frame: 6 years after surgery

    assess the patient's sexual disorders with Female Sexual Function Index (FSFI) 19-item test (score below 26.55 indicates the presence of sexual dysfunctions)

  5. Quality of Life 1

    Time frame: 12 months after surgery

    The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30 ( European organisation for research and treatment of cancer- quality of life questionnaire)

  6. Quality of Life 2

    Time frame: 6 years after surgery

    The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30( European organisation for research and treatment of cancer- quality of life questionnaire)

  7. Quality of life SF-36 1

    Time frame: 12 months after surgery

    The impact of sexual disorders in QoL was evaluated using SF-36 score (Short Form Health Survey 36)

  8. Quality of life SF-36 2

    Time frame: 6 years after surgery

    The impact of sexual disorders in QoL was evaluated using SF- 36 score ( Short Form Health Survey 36 )

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Acronym: IMAPSEX

Important dates

Study start
2012
Primary completion
2018
Study completion
2024
First posted
Feb 12, 2021
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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