Sexual Function Disturbances
Conditions
Keywords
Sexual function, Colonic diverticular disease, Inferior mesenteric artery-preserving, Neosigmoid Denervation, Postoperative sexual dysfunction
Brief summary
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).
Detailed description
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.
Interventions
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
PROCEDUREInferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual disfunction 1 | 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) |
| Sexual disfunction 2 | 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
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function Female 1 | 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) |
| Sexual Function Female 2 | 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) |
| Quality of Life 1 | 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) |
| Sexual Function Male 1 | 12 month after surgery | assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test |
| Quality of life SF-36 1 | 12 months after surgery | The impact of sexual disorders in QoL was evaluated using SF-36 score (Short Form Health Survey 36) |
| Quality of life SF-36 2 | 6 years after surgery | The impact of sexual disorders in QoL was evaluated using SF- 36 score ( Short Form Health Survey 36 ) |
| Quality of Life 2 | 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) |
| Sexual Function Male 2 | 6 years after surgery | assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test |
Countries
Italy
Outcome results
None listed