Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer

NCT02770911 | Unknown Phase 3 DMC

• 1 other identifier: FJMU-20160424
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.

Conditions

Rectal Carcinoma; Laparoscopy; Anastomotic Leak

Keywords

Rectal Carcinoma; Laparoscopy; Anastomotic Leak; Double-stapling technique

Outcome Measures

Primary Outcomes (1)

• anastomotic leakage rate

  30 days since the date of surgery

Secondary Outcomes (5)

• Intra-operative and post-operative complications

  30 days since the date of surgery

• post-operative Mortality

  30 days since the date of surgery

• re-operation rate

  30 days since the date of surgery

• QLQ 30

  at postoperative 3,6 and 12 months

• Wexner's scoring

  at postoperative 3,6 and 12 months

Study Arms (2)

without "Dog Ear" group

EXPERIMENTAL

Before anastomosis, the surgeon made a laparoscopic suturing on the two dog ears by using 3-0 monofilament sutures, and pull two dogears of staple line around the trocar by a tied suture through two dog ears. By this way, the staple line was kept within the circular knife when the circular stapler was closed. Then a true end-to-end anastomosis was performed after stapler firing.

Procedure: without "Dog Ear" group

with "Dog Ear" group

ACTIVE COMPARATOR

traditional double-stapled anastomosis was used for laparoscopic anterior resection

Procedure: with "Dog Ear" group

Interventions

without "Dog Ear" group PROCEDURE

a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection

Also known as: modified laparoscopic double-stapled anastomosis

without "Dog Ear" group

with "Dog Ear" group PROCEDURE

a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection

Also known as: traditional laparoscopic double-stapled anastomosis

with "Dog Ear" group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility rule of enrollment
• Rectal adenocarcinoma above the peritoneal reflection
• at least 18 years old \& at most 80 years old
• Clinically diagnosed cT1-T4aN0-2 disease
• no contraindication to laparoscopic surgery
• without other malignancies in medical history

You may not qualify if:

• concurrent or previous diagnosis of invasive cancer within 5 years
• locally advanced cancers requiring en bloc multivisceral resection
• intestinal obstruction
• intestinal perforation
• American Society of Anesthesiologists(ASA) class 4 or 5
• pregnant or breast-feeding women
• history of mental disorder
• participation in another rectal cancer clinical trial relating to surgical technique

Sponsors & Collaborators

• Fujian Medical University: lead

Related Publications (5)

• Roumen RM, Rahusen FT, Wijnen MH, Croiset van Uchelen FA. "Dog ear" formation after double-stapled low anterior resection as a risk factor for anastomotic disruption. Dis Colon Rectum. 2000 Apr;43(4):522-5. doi: 10.1007/BF02237198.

  PMID: 10789750 RESULT

• Kang J, Lee HB, Cha JH, Hur H, Min BS, Baik SH, Kim NK, Sohn SK, Lee KY. Feasibility and impact on surgical outcomes of modified double-stapling technique for patients undergoing laparoscopic anterior resection. J Gastrointest Surg. 2013 Apr;17(4):771-5. doi: 10.1007/s11605-012-2122-0. Epub 2013 Jan 4.

  PMID: 23288715 RESULT

• Kim HJ, Choi GS, Park JS, Park SY. Comparison of intracorporeal single-stapled and double-stapled anastomosis in laparoscopic low anterior resection for rectal cancer: a case-control study. Int J Colorectal Dis. 2013 Jan;28(1):149-56. doi: 10.1007/s00384-012-1582-8. Epub 2012 Sep 27.

  PMID: 23014975 RESULT

• Chen ZF, Liu X, Jiang WZ, Guan GX. Laparoscopic double-stapled colorectal anastomosis without "dog-ears". Tech Coloproctol. 2016 Apr;20(4):243-7. doi: 10.1007/s10151-016-1437-3. Epub 2016 Feb 22. No abstract available.

  PMID: 26902367 RESULT

• Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.

  PMID: 20004450 RESULT

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guo-xian Guan, MD,PhD

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo-xian Guan, MD,PhD

CONTACT

86-13609592321; gxguan1108@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 12, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: May 12, 2016

Record last verified: 2016-05