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Completed

NCT Number: NCT02627729

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

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

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Key information

Conditions

Quality of Life Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Short Form 36 Quality of life Questionnaire

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

Secondary outcomes

  1. Postoperative complications

    Time frame: 30 days postoperatively

  2. Functional outcome measured with Fecal Incontinence Severity Index

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

  3. Functional outcome measured with Sexual Health Inventory

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

  4. Functional outcome measured with Overactive Bladder validated 8 scale

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

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Dec 11, 2015
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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