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

Quality of Life Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627729
• Other study ID #: DrLutfi2
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: December 9, 2015
• Start date: June 2009
• Est. completion date: February 2014

Study information

• Verified date: December 2015
• Source: Dr.Lütfi Kirdar Kartal Egitim ve Arastirma Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2014
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence
• Postoperative Complications
• Quality of Life

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr.Lütfi Kirdar Kartal Egitim ve Arastirma Hastanesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form 36 Quality of life Questionnaire		Change from baseline scores at 4th, 8th and 12th months after stoma reversal	No
Secondary	Postoperative complications		30 days postoperatively	No
Secondary	Functional outcome measured with Fecal Incontinence Severity Index		Change from baseline scores at 4th, 8th and 12th months after stoma reversal	No
Secondary	Functional outcome measured with Sexual Health Inventory		Change from baseline scores at 4th, 8th and 12th months after stoma reversal	No
Secondary	Functional outcome measured with Overactive Bladder validated 8 scale		Change from baseline scores at 4th, 8th and 12th months after stoma reversal	No