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

NCT ID: NCT02627729

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Quality of Life Fecal Incontinence Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Linear cutter-Circular stapler J pouch

J pouch anal anastomosis after laparoscopic low anterior resection

Group Type ACTIVE_COMPARATOR

Linear cutter-Circular stapler

Intervention Type 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

Circular stapler Side-to-end anastomosis

side to end coloanal anastomosis after laparoscopic low anterior resection

Group Type ACTIVE_COMPARATOR

Circular stapler

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nuri Okkabaz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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DrLutfi2

Identifier Type: -

Identifier Source: org_study_id