Clinical trial NCT02770911: Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer
Official title: Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rectal Carcinoma
Laparoscopy
Anastomotic Leak
Keywords: Rectal Carcinoma
Laparoscopy
Anastomotic Leak
Double-stapling technique
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: anastomotic leakage rate
timeFrame: 30 days since the date of surgery
Secondary outcomes:
measure: Intra-operative and post-operative complications
timeFrame: 30 days since the date of surgery
measure: post-operative Mortality
timeFrame: 30 days since the date of surgery
measure: re-operation rate
timeFrame: 30 days since the date of surgery
measure: QLQ 30
timeFrame: at postoperative 3,6 and 12 months
measure: Wexner's scoring
timeFrame: at postoperative 3,6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Guo-xian Guan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/BF02237198.
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. doi: 10.1007/s11605-012-2122-0. Epub 2013 Jan 4.
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/s00384-012-1582-8. Epub 2012 Sep 27.
citation: 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.
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, 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.