An interventional study of Inferior Mesenteric Artery Preservation and Inferior Mesenteric Artery Ligation in Sexual Function Disturbances, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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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).
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.
138 studies on the registry are indexed under Sexual Dysfunctions, Psychological; 10 are open to participants now.
This study's enrollment of 300 is above the median of 100 across 114 interventional studies indexed under Sexual Dysfunctions, Psychological.
Browse Sexual Dysfunctions, Psychological studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
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)
Time frame: 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)
Time frame: 6 years after surgery
Sexual Function Male 1
assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test
Time frame: 12 month after surgery
Sexual Function Male 2
assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test
Time frame: 6 years after surgery
Sexual Function Female 1
assess the patients' sexual disorders withFemale Sexual Function Index (FSFI) a 19-item test (score below 26.55 indicates the presence of sexual dysfunctions)
Time frame: 12 months after surgery
Sexual Function Female 2
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)
Time frame: 6 years after surgery
Quality of Life 1
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)
Time frame: 12 months after surgery
Quality of Life 2
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)
Time frame: 6 years after surgery
Quality of life SF-36 1
The impact of sexual disorders in QoL was evaluated using SF-36 score (Short Form Health Survey 36)
Time frame: 12 months after surgery
Quality of life SF-36 2
The impact of sexual disorders in QoL was evaluated using SF- 36 score ( Short Form Health Survey 36 )
Time frame: 6 years after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2012 to primary completion in Jan 2018, 72 months.
Of 30 non-industry interventional studies with no phase under Sexual Dysfunctions, Psychological, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 72 months is above that.
Counting every sponsor, half of 30 studies reached it within 21 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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