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

J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer: Short and Long-Term Outcomes of a Prospective Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Postoperative Complications; Fecal Incontinence
• Intervention / Treatment: Device: Linear cutter-Circular stapler; Device: Circular stapler

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Linear cutter-Circular stapler J pouch; J pouch anal anastomosis after laparoscopic low anterior resection	Device: Linear 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
Active Comparator: Circular stapler Side-to-end anastomosis; side to end coloanal anastomosis after laparoscopic low anterior resection	Device: Circular 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Fecal Incontinence
• Other Study ID Numbers: DrLutfi2