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

Laparoscopy Clinical Trial

Official title:

Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02770911
• Other study ID #: FJMU-20160424
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 8, 2016
• Last updated: May 11, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2016
• Source: Fujian Medical University
• Contact: Guo-xian Guan, MD,PhD
• Phone: 86-13609592321
• Email: gxguan1108[@]126.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Interventional

Clinical Trial 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.

Description:

Laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. But the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. The lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. Previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. But because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. In this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Leak
• Laparoscopy
• Rectal Carcinoma

Intervention

Procedure:
• without "Dog Ear" group
a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
• with "Dog Ear" group
a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

References & Publications (5)

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. — View Citation

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. — View Citation

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- — View Citation

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, Büchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal b — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomotic leakage rate		30 days since the date of surgery	Yes
Secondary	Intra-operative and post-operative complications		30 days since the date of surgery	Yes
Secondary	post-operative Mortality		30 days since the date of surgery	Yes
Secondary	re-operation rate		30 days since the date of surgery	Yes
Secondary	QLQ 30		at postoperative 3,6 and 12 months	No
Secondary	Wexner's scoring		at postoperative 3,6 and 12 months	No