Fecal Incontinence, Postoperative Complications, Quality of Life
Conditions
Brief summary
Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection
Interventions
DEVICELinear cutter-Circular stapler
a 5 to 6 cm-long colonic pouch will be created with a 80 mm linear cutting-closing stapler. The anastomosis of j-pouch will be routinely strengthened with 3:0 vicryl sutures. Then, a pouch to anal anastomosis will be performed
DEVICECircular stapler
a 5 to 6 cm-long colonic segment will be left at the distal part and a side-to-end anastomosis will be performed.
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope
Exclusion criteria
* refusal of the patient to participate * pregnancy, * previous radiation therapy, * those have cancers other than adenocarcinoma, * those planned to have local excision or abdominoperineal resection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short Form 36 Quality of life Questionnaire | Change from baseline scores at 4th, 8th and 12th months after stoma reversal |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complications | 30 days postoperatively |
| Functional outcome measured with Fecal Incontinence Severity Index | Change from baseline scores at 4th, 8th and 12th months after stoma reversal |
| Functional outcome measured with Sexual Health Inventory | Change from baseline scores at 4th, 8th and 12th months after stoma reversal |
| Functional outcome measured with Overactive Bladder validated 8 scale | Change from baseline scores at 4th, 8th and 12th months after stoma reversal |
Outcome results
None listed