J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer

Not Applicable

Completed

• Conditions: Fecal Incontinence; Quality of Life; Postoperative Complications
• Interventions: Device: Circular stapler; Device: Linear cutter-Circular stapler

• Registration Number: NCT02627729
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2012-04
• Study Completion: 2014-02
• Status Verified: 2015-12
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Last Update Submitted: 2015-12-09
• Study First Posted: 2015-12-11
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circular stapler Side-to-end anastomosis	Circular stapler	side to end coloanal anastomosis after laparoscopic low anterior resection
Linear cutter-Circular stapler J pouch	Linear cutter-Circular stapler	J pouch anal anastomosis after laparoscopic low anterior resection

Primary Outcome Measures

Name	Time	Method
Short Form 36 Quality of life Questionnaire	Change from baseline scores at 4th, 8th and 12th months after stoma reversal

Secondary Outcome Measures

Name	Time	Method
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