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

NCT02627729 | Completed

• 1 other identifier: DrLutfi2
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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

Conditions

Quality of Life; Fecal Incontinence; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Short Form 36 Quality of life Questionnaire

  Change from baseline scores at 4th, 8th and 12th months after stoma reversal

Secondary Outcomes (4)

• 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

Study Arms (2)

Linear cutter-Circular stapler J pouch

ACTIVE COMPARATOR

J pouch anal anastomosis after laparoscopic low anterior resection

Device: Linear cutter-Circular stapler

Circular stapler Side-to-end anastomosis

ACTIVE COMPARATOR

side to end coloanal anastomosis after laparoscopic low anterior resection

Device: Circular stapler

Interventions

Linear cutter-Circular stapler DEVICE

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

Linear cutter-Circular stapler J pouch

Circular stapler DEVICE

a 5 to 6 cm-long colonic segment will be left at the distal part and a side-to-end anastomosis will be performed.

Circular stapler Side-to-end anastomosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Fecal Incontinence; Postoperative Complications

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 11, 2015
• Study Start: June 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: February 1, 2014
• Last Updated: December 11, 2015

Record last verified: 2015-12