An interventional study of IMA preserving and IMA sectioning in Colonic Diverticuar Disease, Defecatory Functions and Fecal Incontinence, sponsored by University of Roma La Sapienza. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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
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.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
This study's enrollment of 300 is above the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Performing colorectal resection for diverticular disease the IMA was preserved ligating the sigmoids arteries close to colonic wall.
Procedure: IMA preserving
Performing colorectal resection the IMA was sectioned just below the origin of left colic artery.
Procedure: IMA sectioning
Performing left hemicolectomy, sigmoidectomy or rectal resection the IMA was preserved ligating the sigmoids arteries close to the colonic wall
Performing left emicolectomy, sigmoidectomy or rectal resection the IMA is sectioned after the origin of left colic artery.
Defecatory disorders
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
Time frame: 6 months from surgery
Defecatory disorders
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
Time frame: 12 months from surgery
Defecatory disorders
the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)
Time frame: 6 years from surgery
Constipation
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)
Time frame: 6 months from surgery
Constipation
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)
Time frame: 12 months from surgery
Constipation
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)
Time frame: 6 years from surgery
Incontinence
The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score range from 0 to 20, the higher score defines worse symptoms)
Time frame: 6 months from surgery
Incontinence
The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score range from 0 to 20, the higher score defines worse symptoms)
Time frame: 12 months from surgery
Incontinence
The presence of fecal incontinence was evaluated with Cleveland Clinic Incontinence Score( score ranges from 0 to 20, the higher score defines worse symptoms)
Time frame: 6 years from surgery
Anorectal Muscles function
The anorectal muscles function was evaluated with anorectal manometry( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)
Time frame: 6 months from surgery
Anorectal Muscles function
the anorectal muscles function was evaluated with anorectal manometry ( sphincter lenght, maximum squeeze pression, resting anal pressure, squeeze duration, maximum pressure sustained)
Time frame: 6 years from surgery
Postoperative quality of life
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)
Time frame: 6 months from surgery
Postoperative quality of life
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
Time frame: 12 months from surgery
Postoperative quality of life
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)
Time frame: 6 years from surgery
Postoperative quality of life
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)
Time frame: 12 months from surgery
Postoperative quality of life
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)
Time frame: 6 years from surgery
Postoperative quality of life
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)
Time frame: 6 months from surgery
Postoperative quality of life
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)
Time frame: 6 months from surgery
Postoperative quality of life
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)
Time frame: 12 months from surgery
Postoperative quality of life
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)
Time frame: 6 years from surgery
Postoperative surgical complication
The incidence of postoperative surgical complications was evaluated
Time frame: 1 month from surgery
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2012 to primary completion in Jan 2024, 144 months.
Of 70 non-industry interventional studies with no phase under Fecal Incontinence, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's 144 months is above that.
Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
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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