Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique

NCT02879370 | Completed DMC

• 1 other identifier: 65/14
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The technique the investigators propose to perform colorectal and colo-anal anastomosis in patients underwent low and ultra-low anterior resection for rectal cancer could potentially reduce the anastomotic leakage rate by better trans-anal introduction of the circular stapler, elimination of the previous suture lines and dog ears, combined with direct inspection of the anastomosis, easy performance of trans-anal air leak tests and eventually direct repair of any small anastomotic defects. Another important point in cancer surgery is the easily identification of the distal margin. In fact, this technique is simple to perform, reproducible and safe in terms of complications.

Conditions

Anastomotic Leak

Keywords

Anastomotic Leak; Rectal cancer; Double stapling technique

Outcome Measures

Primary Outcomes (1)

• Incidence of anastomotic leakage after intervention

  The authors adapted these criteria for diagnosis of anastomotic leakage; fecal material from the drain or the wound, extravasation of dye on contrast enema, anastomotic defect visualized by colonoscopy, or the presence of peri-anastomotic air or fluid visualized by CT scan.

  1 year

Secondary Outcomes (2)

• Safety margin after tumor resection

  1 year

• Postoperative morbidities and mortalities

  1 year

Study Arms (1)

TICRANT

EXPERIMENTAL

Transanal Inspection and management of low ColoRectal Anastomosis

Procedure: Transanal Inspection and management of low ColoRectal Anastomosis

Interventions

Transanal Inspection and management of low ColoRectal Anastomosis PROCEDURE

Low anterior resection with total mesorectal excision (TME), either performed open, laparoscopic or robotic Closure of the rectum with linear or curved stapler with transanal inspection Transanal placement of four 2-0 prolene sutures on the rectal stump, respectively 2 at the extremities of the suture line (left and right) and other two 1 cm medial to each of the previous two sutures Circular stapler is introduced, the 4 tails of the prolene stitches are introduced through the windows (2 in the left and 2 in the right side of the instrument) and gently pulled, to obtain a gradual and homogeneous traction of the tissue and elimination of both previous suture lines and doggy ears, then the stapler is fired The termino-terminal anastomosis is carefully inspected A leak test can be performed (if negative the protective stoma is not performed) An eventual leak can be transanally repaired

TICRANT

Eligibility Criteria

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

You may qualify if:

• Patients undergoing low or ultra-low anterior resection for biopsy proven primary rectal cancer

You may not qualify if:

• Patients younger than 18 years old,
• pregnant,
• recurrent disease,
• cancer less than 4 cm from the anal verge,
• abdomeno-perineal resection,
• emergency surgery

Sponsors & Collaborators

• University of Rome Tor Vergata: lead
• San Giuseppe Moscati Hospital: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator
• Casa di Cura San Pio X, Milano, Italy: collaborator
• Policlinico Abano Terme: collaborator
• Ospedale Maggiore, Bologna Italy: collaborator

Study Sites (1)

University of Rome Tor Vergata

Rome, RM, 00133, Italy

Location

Related Publications (12)

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  PMID: 9718009 BACKGROUND

• Edwards DP, Leppington-Clarke A, Sexton R, Heald RJ, Moran BJ. Stoma-related complications are more frequent after transverse colostomy than loop ileostomy: a prospective randomized clinical trial. Br J Surg. 2001 Mar;88(3):360-3. doi: 10.1046/j.1365-2168.2001.01727.x.

  PMID: 11260099 BACKGROUND

• Heuschen UA, Hinz U, Allemeyer EH, Autschbach F, Stern J, Lucas M, Herfarth C, Heuschen G. Risk factors for ileoanal J pouch-related septic complications in ulcerative colitis and familial adenomatous polyposis. Ann Surg. 2002 Feb;235(2):207-16. doi: 10.1097/00000658-200202000-00008.

  PMID: 11807360 BACKGROUND

• Kockerling F, Rose J, Schneider C, Scheidbach H, Scheuerlein H, Reymond MA, Reck T, Konradt J, Bruch HP, Zornig C, Barlehner E, Kuthe A, Szinicz G, Richter HA, Hohenberger W. Laparoscopic colorectal anastomosis: risk of postoperative leakage. Results of a multicenter study. Laparoscopic Colorectal Surgery Study Group (LCSSG). Surg Endosc. 1999 Jul;13(7):639-44. doi: 10.1007/s004649901064.

  PMID: 10384066 BACKGROUND

• Marusch F, Koch A, Schmidt U, Geibetaler S, Dralle H, Saeger HD, Wolff S, Nestler G, Pross M, Gastinger I, Lippert H. Value of a protective stoma in low anterior resections for rectal cancer. Dis Colon Rectum. 2002 Sep;45(9):1164-71. doi: 10.1007/s10350-004-6384-9.

  PMID: 12352230 BACKGROUND

• Merad F, Hay JM, Fingerhut A, Yahchouchi E, Laborde Y, Pelissier E, Msika S, Flamant Y. Is prophylactic pelvic drainage useful after elective rectal or anal anastomosis? A multicenter controlled randomized trial. French Association for Surgical Research. Surgery. 1999 May;125(5):529-35.

  PMID: 10330942 BACKGROUND

• Moran BJ. Stapling instruments for intestinal anastomosis in colorectal surgery. Br J Surg. 1996 Jul;83(7):902-9. doi: 10.1002/bjs.1800830707.

  PMID: 8813772 BACKGROUND

• Pakkastie TE, Ovaska JT, Pekkala ES, Luukkonen PE, Jarvinen HJ. A randomised study of colostomies in low colorectal anastomoses. Eur J Surg. 1997 Dec;163(12):929-33.

  PMID: 9449446 BACKGROUND

• Selvasekar CR, Cima RR, Larson DW, Dozois EJ, Harrington JR, Harmsen WS, Loftus EV Jr, Sandborn WJ, Wolff BG, Pemberton JH. Effect of infliximab on short-term complications in patients undergoing operation for chronic ulcerative colitis. J Am Coll Surg. 2007 May;204(5):956-62; discussion 962-3. doi: 10.1016/j.jamcollsurg.2006.12.044.

  PMID: 17481518 BACKGROUND

• Urbach DR, Kennedy ED, Cohen MM. Colon and rectal anastomoses do not require routine drainage: a systematic review and meta-analysis. Ann Surg. 1999 Feb;229(2):174-80. doi: 10.1097/00000658-199902000-00003.

  PMID: 10024097 BACKGROUND

• Vignali A, Fazio VW, Lavery IC, Milsom JW, Church JM, Hull TL, Strong SA, Oakley JR. Factors associated with the occurrence of leaks in stapled rectal anastomoses: a review of 1,014 patients. J Am Coll Surg. 1997 Aug;185(2):105-13. doi: 10.1016/s1072-7515(97)00018-5.

  PMID: 9249076 BACKGROUND

• Wexner SD, Cohen SM, Ulrich A, Reissman P. Laparoscopic colorectal surgery--are we being honest with our patients? Dis Colon Rectum. 1995 Jul;38(7):723-7. doi: 10.1007/BF02048029.

  PMID: 7607032 BACKGROUND

Related Links

• The published paper

MeSH Terms

Conditions

Anastomotic Leak; Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Francesco Crafa, MD

  San Giuseppe Moscati Hospital

  STUDY DIRECTOR

• Giovanni Romano, MD

  Fondazione G. Pascale

  STUDY CHAIR

• Jacques Megevand, MD

  Pavia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FACS Assistant Professor of Surgery

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: August 25, 2016
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

IT (1)