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

Dr. Lutfi Kirdar Kartal Training and Research Hospital74 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Quality of Life Fecal Incontinence Postoperative Complications

Interventions

Linear cutter-Circular staplerDEVICE

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

Circular staplerDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Short Form 36 Quality of life Questionnaire

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

Secondary Outcomes

Postoperative complications

Time frame: 30 days postoperatively

Functional outcome measured with Fecal Incontinence Severity Index

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

Functional outcome measured with Sexual Health Inventory

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

Functional outcome measured with Overactive Bladder validated 8 scale

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

Data from ClinicalTrials.gov

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