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Completed

NCT Number: NCT06506552

Effects of Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease.

This is a prospective randomized study aimed to verifying the short and long-term results of inferior mesenteric artery preservation following colorectal resection for diverticular disease

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Key information

Conditions

Colonic Diverticuar Disease Constipation Defecatory Functions Digestive System Diseases Diverticular Diseases Fecal Incontinence Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study wants to demonstrate that the preservation of the inferior mesenteric artery allow to improve postoperative defecatory function and improve patient's quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI < 35
  • ASA I-III
  • Hinchey I-III

Exclusion criteria

  • BMI > 35
  • ASA IV
  • Hinchey IV
  • Previous procedures that could have been modified the nervous mesenteric pattern (surgery, radiotherapy or chemotherapy)

Treatment and study plan

IMA preserving

Procedure

Performing left hemicolectomy, sigmoidectomy or rectal resection the IMA was preserved ligating the sigmoids arteries close to the colonic wall

IMA sectioning

Procedure

Performing left emicolectomy, sigmoidectomy or rectal resection the IMA is sectioned after the origin of left colic artery.

Primary outcomes

  1. Defecatory disorders

    Time frame: 6 months from surgery

    the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)

  2. Defecatory disorders

    Time frame: 12 months from surgery

    the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)

  3. Defecatory disorders

    Time frame: 6 years from surgery

    the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)

Secondary outcomes

  1. Constipation

    Time frame: 6 months from surgery

    The incidence and severity of postoperative constipation was evaluated with Cleveland Clinic Constipation Score ( score range from 0 to 30, the higher score defines worse constipation status)

  2. Constipation

    Time frame: 12 months from surgery

    The incidence and severity of postoperative constipation was evaluated with Cleveland Clinic Constipation Score ( score range from 0 to 30, the higher score defines worse constipation status)

  3. Constipation

    Time frame: 6 years from surgery

    The incidence and severity of postoperative constipation was evaluated with Cleveland Clinic Constipation Score ( score range from 0 to 30, the higher score defines worse constipation status)

  4. Incontinence

    Time frame: 6 months from surgery

    The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score range from 0 to 20, the higher score defines worse symptoms)

  5. Incontinence

    Time frame: 12 months from surgery

    The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score range from 0 to 20, the higher score defines worse symptoms)

  6. Incontinence

    Time frame: 6 years from surgery

    The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score ranges from 0 to 20, the higher score defines worse symptoms)

  7. Anorectal Muscles function

    Time frame: 6 months from surgery

    The anorectal muscles function was evaluated with anorectal manometry( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)

  8. Anorectal Muscles function

    Time frame: 6 years from surgery

    the anorectal muscles function was evaluated with anorectal manometry ( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)

  9. Postoperative quality of life

    Time frame: 6 months from surgery

    the postoperative QOL(quality of life) was evaluated with EORTC-30 tests( European organization for research and treatment of cancer, scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms)

  10. Postoperative quality of life

    Time frame: 12 months from surgery

    the postoperative QOL was evaluated with EORTC-30 tests( European organization for research and treatment of cancer,scores range from 0 to 100; a higher score represents a higher "better" level of functioning, or a higher "worse" level of symptoms

  11. Postoperative quality of life

    Time frame: 6 years from surgery

    The postoperative QOL was evaluated with EORTC-30 tests( European organization for research and treatment of cancer,scores range from 0 to 100; a higher score represents a higher "better" level of functioning, or a higher "worse" level of symptoms)

  12. Postoperative quality of life

    Time frame: 12 months from surgery

    The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)

  13. Postoperative quality of life

    Time frame: 6 years from surgery

    The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)

  14. Postoperative quality of life

    Time frame: 6 months from surgery

    The postoperative QOL was evaluated with EORTC-29 tests (European organization for research and treatment of cancer each question goes from 1 to 4 , the higher score defines worse symptoms)

  15. Postoperative quality of life

    Time frame: 6 months from surgery

    The postoperative QOL(quality of life) was evaluated with SF-36 score (Short form-36 score, each item scored from 0 to 100, the higher scores defines a favorable health state)

  16. Postoperative quality of life

    Time frame: 12 months from surgery

    The postoperative QOL was evaluated with SF-36 score (Short form-36 score, each item scored from 0 to 100, the higher scores defines a favorable health state)

  17. Postoperative quality of life

    Time frame: 6 years from surgery

    The postoperative QOL was evaluated with SF-36 score (Short form-36 score, each item scored from 0 to 100, the higher scores defines a favorable health state)

  18. Postoperative surgical complication

    Time frame: 1 month from surgery

    The incidence of postoperative surgical complications was evaluated

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease; Short and Long Term Effects in Defecatory Function

Acronym: EIMAP

Important dates

Study start
2012
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Jul 23, 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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