Effects of Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease.
NCT Number: NCT06506552
Acronym: EIMAP
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colonic Diverticuar Disease|Defecatory Functions|Fecal Incontinence|Constipation
Interventions: PROCEDURE: IMA preserving|PROCEDURE: IMA sectioning
Sponsor: University of Roma La Sapienza
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2012-01-01
Completion Date: 2024-01-20

Summary:
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

Primary Outcome Measures: Defecatory disorders, the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence), 6 months from surgery|Defecatory disorders, the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence), 12 months from surgery|Defecatory disorders, the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence), 6 years from surgery
Secondary Outcome Measures: 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), 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), 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), 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), 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), 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), 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), 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), 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), 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, 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), 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), 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), 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), 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), 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), 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), 6 years from surgery|Postoperative surgical complication, The incidence of postoperative surgical complications was evaluated, 1 month from surgery