A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler

Rectal Neoplasms Clinical Trial

Official title:

A Prospective Randomized Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02565667
• Other study ID #: FudanKOL
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2015
• Last updated: March 24, 2016
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: Fudan University
• Contact: Li Xin-Xiang, M.D & Ph.D.
• Phone: +86-18017312900
• Email: lxx1149[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Up to now, kinds of surgical devices have been employed to reduce anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the problem of "dog ear" phenomena. In the present clinical trial, the investigators use a double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The investigators aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.

Description:

About 5-10% of patients receiving low rectal resection using traditional anastomosis occurred anastomotic leak, risk factors for which included patient related (age, gender, tumor distance from the anal verge), hypoproteinemia, diabetes mellitus, etc), procedure related (emergency) and technical related (one stapler, double stapler or handsewn).

Anastomotic leak caused prolonged hospital stay, delayed post-operative adjuvant radiochemotherapy and need of stoma in some cases. Besides, anastomotic leak was reported to be associated with increased local recurrence rate. Thus, it's of great importance to develop new surgical devices to prevent "dog ear" problem and reduce the anastomotic leak rate.

Double stapled pursestring anastomosis was the one of the most widely used methods in lower rectal resection. One major problem of this procedure was creating one or double side "dog ear" phenomenon (Dis Colon Rectum. 2000 Apr;43(4):522-5. Fig 1). This weak spot was theoretically responsible for post-operative anastomotic leak as demonstrated by animal experiments and clinical practice.

In this clinical trial, we used a transanal double purse-string rectal anastomosis preformed with KOL stapler for lower rectal resection. This procedure would resolve the dog ear problem through circular anastomosis taking care that the anastomotic site contained only gut tissues without any staples. We aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. pathological confirmed rectal adenocarcinoma

2. less than 10 cm of distal tumor margin from the anal edge

3. less than 4 cm of maximum tumor diameter and less than 1/2 of circumference diameter

4. tumor stage earlier than cT1-3N0M0 before surgery or that following neoadjuvant radiochemotherapy

5. normal defecation function (Wexner score < 4)

6. open or laparoscopic operation

Exclusion Criteria:

1. recurrent cases

2. emergency including obstruction, bleeding or perforation

3. severe abdominal adhesions

4. severe malnutrition can not be improved before surgery

5. can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney

6. refractory hypoproteinemia or diabetes mellitus

Study Design

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Device:
• KOL
KOL staple was used for rectal anastomosis
• traditional staple
traditional staple was used for rectal anastomosis

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (6)

Espín E, Ciga MA, Pera M, Ortiz H; Spanish Rectal Cancer Project. Oncological outcome following anastomotic leak in rectal surgery. Br J Surg. 2015 Mar;102(4):416-22. doi: 10.1002/bjs.9748. Epub 2015 Jan 26. — View Citation

Midura EF, Hanseman D, Davis BR, Atkinson SJ, Abbott DE, Shah SA, Paquette IM. Risk factors and consequences of anastomotic leak after colectomy: a national analysis. Dis Colon Rectum. 2015 Mar;58(3):333-8. doi: 10.1097/DCR.0000000000000249. — View Citation

Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929. Review. — View Citation

Morse BC, Simpson JP, Jones YR, Johnson BL, Knott BM, Kotrady JA. Determination of independent predictive factors for anastomotic leak: analysis of 682 intestinal anastomoses. Am J Surg. 2013 Dec;206(6):950-5; discussion 955-6. doi: 10.1016/j.amjsurg.2013.07.017. Epub 2013 Sep 24. — 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

Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomotic leak rate	percentage of patients occuring anastomotic leak within 30 days since surgery	30 days since the date of surgery	Yes
Secondary	post-operative anal function		within one year since the date of surgery	No
Secondary	30-day mortality rate		within 30 days since the date of surgery	Yes