Lateral Invagination of the Colorectal Anastomosis by Double Stapling

NCT04553250 | Unknown

• 1 other identifier: HCB/2020/1057
• Study Type: interventional
• Target: 786
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anastomotic dehiscence is the most feared complication in colorectal surgery, occurring in 6.3% -13.7% in patients with pelvic anastomoses \[1-4\]. This complication significantly increases morbidity, mortality, costs, and generates a greater impact on quality of life. In addition, several studies point to an increased risk of locoregional recurrence \[5, 6\]. There are different risk factors for anastomotic dehiscence: some preoperative, such as malnutrition or obesity \[9\]; other intraoperative ones, such as hypoperfusion of the anastomotic tissue or the anastomotic technique; and others postoperative, such as some types of medication \[7\]. In colorectal anastomoses, there is some concern about the safety of the double stapling technique, since the extremes of the linear suture line (called "dog ears") and the number of staple lines have a direct relationship with the risk of dehiscence \[8-11\]. With the aim of reducing suture dehiscence rates, different intraoperative techniques have been developed, such as reinforcing the anastomosis with stitches, the use of indocyanine green \[12, 13\] or the application of anastomotic sealants \[14\], without finding a definitive solution. Recently, benefits have been published of using the double-staple colorectal anastomosis lateral invagination technique, with the aim of avoiding "dog ears" \[15-17\]. Several case series and retrospective comparative studies have shown a significant decrease in anastomotic dehiscence using this technique, with all the clinical and economic benefits that this entails \[15-17\]. In this sense, the present study aims to evaluate the effectiveness and safety of the lateral invagination technique of double-staple colorectal anastomosis in a randomized and controlled trial.

Conditions

Anastomotic Leak; Sigmoid Diseases

Keywords

anastomotic leak; doubled-stapled anastomosis

Outcome Measures

Primary Outcomes (1)

• Rate of anastomotic dehiscence diagnosed in the first 30 postoperative days

  anastomotic dehiscence diagnosis

  30 days

Secondary Outcomes (8)

• Duration of surgery

  1 day

• Rate of perioperative morbidity using the Clavien-Dindo classification.

  30 and 90 days PO or in-hospital stay

• Rate of perioperative mortality

  30 and 90 days PO or in-hospital stay

• Duration of hospital stay

  days

• Rate of hospital readmissions

  30 days

Study Arms (2)

Conventional technique

ACTIVE COMPARATOR

In this group, double-staple colorectal anastomosis will be performed following the technique described by Lee et al: Prior to firing the endostapler, a suture will be placed on the rectal stump that includes both "dog ears". After the punch comes out of the endostapler, the point will be tied, which will invaginate the two corners of the staple line on the same punch. Subsequently, the endostapler will be closed and fired, including the "dog ears" in the anastomotic rims

Procedure: Doubled-stapled colorectal anastomosis

Lateral invagination technique

ACTIVE COMPARATOR

In this group, the circular endostapler will be fired in a conventional way, that is, without having invaginated the two corners of the staple line.

Procedure: Doubled-stapled colorectal anastomosis

Interventions

Doubled-stapled colorectal anastomosis PROCEDURE

Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.

Conventional technique; Lateral invagination technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> 18 years
• Indication of resection of the left colon, sigmoid or upper rectum
• Minimally invasive approach
• Open surgery approach
• Double staple colorectal anastomosis

You may not qualify if:

• Patients \<18 years
• Pregnancy
• ASA\> III
• Absolute contraindication for anesthesia
• Patients who receive more than 1 gastrointestinal anastomosis during the same procedure
• Planned multi-organ resection during the same procedure
• Urgent / emergent surgery
• Reinforced anastomosis after positive intraoperative leak test
• Patients with simultaneous application of debulking and HIPEC
• Crohn's disease or active ulcerative colitis

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Related Publications (20)

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• Gorissen KJ, Benning D, Berghmans T, Snoeijs MG, Sosef MN, Hulsewe KW, Luyer MD. Risk of anastomotic leakage with non-steroidal anti-inflammatory drugs in colorectal surgery. Br J Surg. 2012 May;99(5):721-7. doi: 10.1002/bjs.8691. Epub 2012 Feb 9.

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  PMID: 18379795 BACKGROUND

• Kim JS, Cho SY, Min BS, Kim NK. Risk factors for anastomotic leakage after laparoscopic intracorporeal colorectal anastomosis with a double stapling technique. J Am Coll Surg. 2009 Dec;209(6):694-701. doi: 10.1016/j.jamcollsurg.2009.09.021.

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• Boni L, David G, Dionigi G, Rausei S, Cassinotti E, Fingerhut A. Indocyanine green-enhanced fluorescence to assess bowel perfusion during laparoscopic colorectal resection. Surg Endosc. 2016 Jul;30(7):2736-42. doi: 10.1007/s00464-015-4540-z. Epub 2015 Oct 20.

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  PMID: 26394738 BACKGROUND

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  PMID: 27917665 BACKGROUND

• Lee S, Ahn B, Lee S. The Relationship Between the Number of Intersections of Staple Lines and Anastomotic Leakage After the Use of a Double Stapling Technique in Laparoscopic Colorectal Surgery. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):273-281. doi: 10.1097/SLE.0000000000000422.

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  PMID: 29185063 BACKGROUND

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  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak; Sigmoid Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Gastrointestinal Surgery Department

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: March 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share